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Table of content Pharmaceutical impurities

Code Product Price Unit 4-Aminobenzoic Acid MM 0094.00 Imp. B (EP): Benzocaine O (A) 500 mg O

H2N MM 0093.17 Imp. C (EP) as Hydrochloride: Aniline Hydrochloride (B) 100 mg x HCl H2N Acebutolol Hydrochloride MM 0435.00 Acebutolol Hydrochloride O (A) 500 mg OH H O N O N H x HCl MM 0435.01 Imp. A (EP): N-[3-Acetyl-4-[(2RS)-oxiran- O (A) 50 mg 2-ylmethoxy]phenyl]butanamide O O O

N H O MM 0435.02 Imp. B (EP) as Hydrochloride:N-[3-Acetyl-4-[(2RS)- OH (A) 100 mg 2-hydroxy-3-[(1-methylethyl)amino]- H O N propoxy]phenyl]acetamide Hydrochloride O x HCl (Diacetolol Hydrochloride) N H MM 0435.03 Imp. C (EP): N-(3-Acetyl-4-hydroxyphenyl)butanamide O (A) 100 mg OH O

N H O MM 0435.04 Imp. D (EP) as Hydrochloride: 1-[5-Amino-2- OH (A) 50 mg [(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- H O N x 2 HCl propoxy]phenyl]ethanone Dihydrochloride

H2N OH MM 0435.05 Imp. E (EP) as Hydrochloride: N-[4-[(2RS)-2- H (A) 50 mg O N Hydroxy-3-[(1-methylethyl)amino]propoxy]- O x HCl phenyl]butanamide Hydrochloride N H O MM 0435.06 Imp. F (EP): N-[3-Acetyl-4-[(2RS)- OH (A) 50 mg 2,3-dihydroxypropoxy]phenyl]butanamide O OH O

N H O O MM 0435.07 Imp. G (EP): N,N'-[[(1-Methylethyl)imino]- OH OH (A) 50 mg bis[(2-hydroxypropane-1,3-diyl)oxy(3-acetyl- O N O 1,4-phenylene)]]dibutanamide (Acebutolol Biamine) HN NH

O O O O MM 0435.08 Imp. H (EP): N,N'-[(2-Hydroxypropane- OH (A) 50 mg 1,3-diyl)bis[oxy(3-acetyl-1,4-phenylene)]]di- O O butanamide HN NH

O O O MM 0435.09 Imp. I (EP): N-[3-Acetyl-4-[(2RS)-3-(ethylamino)- OH (A) 50 mg 2-hydroxypropoxy]phenyl]butanamide H O N O

N H O MM 0435.10 Imp. J (EP) as Hydrochloride: N-[3-Acetyl-4- OH (A) 50 mg H [(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- O N x HCl propoxy]phenyl]propanamide Hydrochloride O N H O MM 0435.11 Imp. K (EP) as Hydrochloride: N-[3-Butanoyl- OH (A) 50 mg 4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- H O N x HCl propoxy]phenyl]butanamide Hydrochloride O N H

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Code Product Price Unit Aceclofenac MM 0181.00 Aceclofenac O (A) 250 mg O OH O NH Cl Cl

MM 0006.20 Imp. A (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid OH (A) 100 mg (Diclofenac) O NH Cl Cl

MM 0006.10 Imp. B (EP): Methyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate O (A) 100 mg (Methyl Ester of Diclofenac) O NH Cl Cl

MM 0006.11 Imp. C (EP): Ethyl 2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetate O (A) 100 mg (Ethyl Ester of Diclofenac) O NH Cl Cl

MM 0181.01 Imp. D (EP): Methyl [[[2-[(2,6-Dichloro- O (A) 100 mg O phenyl)amino]phenyl]acetyl]oxy]acetate O (Methyl Ester of Aceclofenac) O NH Cl Cl

MM 0181.02 Imp. E (EP): Ethyl [[[2-[(2,6-Dichlorophenyl)amino]- O (A) 100 mg O phenyl]acetyl]oxy]acetate O (Ethyl Ester of Aceclofenac) O NH Cl Cl

MM 0181.03 Imp. F (EP): ): Benzyl[[[2-[(2,6-Dichlorophenyl)amino]- O (A) 100 mg O phenyl]acetyl]oxy]acetate O (Benzyl Ester of Aceclofenac) O NH Cl Cl

MM 0181.04 Imp. G (EP): [[[[[2-[(2,6-Dichlorophenyl)amino]phenyl]- O (A) 100 mg O OH acetyl]oxy]acetyl]oxy]acetic Acid O (Acetic Aceclofenac) O O NH Cl Cl

MM 0181.05 Imp. H (EP): [[[[[[[2-[(2,6-Dichlorophenyl)- O O (A) 50 mg O O amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]- O OH oxy]acetic Acid O O (Diacetic Aceclofenac) NH Cl Cl

MM 0006.01 Imp. I (EP):1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one (A) 100 mg O N Cl Cl

MM 0181.06 Isopropyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate O (A) 100 mg (Isopropyl Ester of Diclofenac) O NH Cl Cl

Acesulfame Potassium MM 1093.01 Imp. A (EP): 3-Oxobutanamide (Acetylacetamide) O (A) 100 mg NH2

O Acetazolamide

MM 0648.00 Acetazolamide H O O (A) 500 mg N S S NH2 O N N

H MM 0648.04 Imp. A (EP): N-(5-Chloro-1,3,4-thiadiazol-2-yl)acetamide S (A) 50 mg Cl N N N O

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Code Product Price Unit

H MM 0648.01 Imp. B (EP): N-(1,3,4-Thiadiazol-2-yl)acetamide S (A) 50 mg N N N O Acetylcysteine MM 0024.00 N-Acetyl-L-cysteine O (A) 500 mg HS OH HN O MM 0024.03 Imp. A (EP): L-Cystine NH2 O (B) 100 mg HO S S OH O NH2 MM 0024.02 Imp. B (EP): L-Cysteine O (B) 100 mg HS OH NH2 MM 0024.04 Imp. C (EP): N,N’-Diacetyl-L-cystine O (A) 100 mg NH O HO S S OH O HN O MM 0024.01 Imp. D (EP): N,S-Diacetyl-L-cysteine O O (A) 100 mg S OH HN O MM 0024.05 Sodium 2-Methyl-4,5-dihydro-1,3-thiazol-4-carboxylate O (A) 100 mg N ONa S MM 0024.06 N-Propionyl-L-cysteine O (A) 100 mg HS OH HN

O Acetylsalicylic Acid MM 0133.00 Acetylsalicylic Acid O O (A) 500 mg HO O

MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg HO OH MM 0045.02 Imp. B (EP): 4-Hydroxybenzene-1,3-dicarboxylic Acid O O (A) 100 mg (4-Hydroxyisophthalic Acid) HO OH OH MM 0045.00 Imp. C (EP): Salicylic Acid O (A) 500 mg OH

OH MM 0133.01 Imp. D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid O (A) 100 mg (Acetylsalicylsalicylic Acid) OH O

O O

O

MM 0133.03 Imp. E (EP):2-[(2-Hydroxybenzoyl)oxy]benzoic Acid O (A) 100 mg (Salicylsalicylic Acid) OH

O OH

O

MM 0133.02 Imp. F (EP): 2-(Acetyloxy)benzoic Anhydride O (A) 100 mg (Acetylsalicylic Anhydride) O O O

O

O

O

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Code Product Price Unit MM 0133.04 2-(2,4-Dihydroxybenzoyl)benzoic Acid O (A) 100 mg OH O

OH

OH MM 0133.08 4-Acetoxyisophthalic Acid O O (A) 50 mg HO OH

O

O MM 0133.09 Acetylsalicylsalicylsalicylic Acid O (A) 50 mg OH

O

O O

O O

O

N-Acetyltryptophan

H MM 1267.01 Imp. A (EP): Tryptophan N (A) 100 mg NH2 OH

O H MM 0172.03 Imp. D (EP): (S)-2-Amino-3-(5-hydroxy- N (A) 100 mg NH2 1H-indol-3-yl)propanoic Acid (5-Hydroxy-tryptophan) OH O HO Aciclovir MM 0061.00 Aciclovir O (A) 500 mg HN N OH N H2 N N O MM 0061.01 Imp. A (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin- O (A) 100 mg N 9-yl)methoxy]ethyl Acetate HN O N O H2N N O MM 0061.02 Imp. B (EP): 2-Amino-1,7-dihydro-6H-purin-6-one O (B) 100 mg H (Guanine) HN N N H2N N O New MM 0061.03 Imp. C (EP): 2-Amino-7-[(2-hydroxy- O OH (A) 100 mg ethoxy)methyl]-1,7-dihydro-6H-purin- N HN 6-one N H2N N

MM 0061.04 Aciclovir Imp. D (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- O (A) 100 mg 9H-purin-9-yl)methoxy]ethylBenzoate N HN O N O H2N N O MM 0061.06 Imp. F (EP): N-[9-[(2-Hydroxyethoxy)methyl]-6-oxo- O (A) 100 mg N 6,9-dihydro-1H-purin-2-yl]acetamide O HN OH N N N H O MM 0061.07 Imp. G (EP): 2-[[(2-(Acetylamino)-6-oxo-1,6-dihydro- O (A) 100 mg N O 9H-purin-9-yl]methoxy]ethyl Acetate O HN O N N N H O

MM 0061.08 Aciclovir Imp. H (EP): 2-[[2-(Acetylamino)-6-oxo- O (A) 100 mg 1,6-dihydro-9H-purin-9-yl]methoxy]ethyl Benzoate N O HN O N N N O H O MM 0061.10 2,6-Dichloropurine Cl (B) 100 mg N N Cl N N H

24 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Adapalene MM 0681.03 Imp. A (EP): 2,2'-Binaphthalene-6,6'-dicarboxylic Acid O (A) 50 mg HO

OH

O MM 0681.01 Imp. C (EP): 1-(2-Methoxyphenyl)tricyclo- O (A) 50 mg 3,7 [3.3.1.1 ]decane

New MM 0681.02 Imp. D (EP): 1,1'-[4,4'Bis(methoxy)biphenyl-3,3'- O (A) 50 mg 3,7 diyl]bis(tricyclo[3.3.1.1 ]decane)

O Adenosine MM 0784.00 Adenosine NH 2 (A) 500 mg N N HO N N O

OH OH

MM 0784.01 Imp. A (EP) as Sulphate: 7H-Purin-6-amine NH2 (A) 100 mg Sulphate (Adenine Sulphate) N N x H2SO4

N N H 2 MM 0784.02 Imp. F (EP): 1- -D-Ribofuranosylpyrimidine- O (A) 100 mg 2,4(1H,3H)-dione (Uridine) HN

HO O N O

OH OH MM 0784.03 Imp. G (EP): 9- -D-Ribofuranosyl-1,9-dihydro- O (A) 100 mg N 6H-purin-6-one (Inosine) HN HO N N O

OH OH MM 0784.04 Imp. H (EP): 2-Amino-9- -D-ribofuranosyl- O (A) 100 mg N 1,9-dihydro-6H-purin-6-one (Guanosine) HN N H2N N HO O

OH OH Adiphenine Hydrochloride

MM 1172.00 Adiphenine Hydrochloride O (A) 250 mg N O x HCl

Adrenaline Tartrate

OH MM 0614.00 Adrenaline Tartrate H (A) 500 mg N OH O x HO OH HO O OH OH

MM 0614.02 L-Adrenaline OH H (A) 500 mg N

HO OH O MM 0614.13 Imp. C (EP) as Hydrochloride: 1-(3,4-Di- H (A) 100 mg HO N hydroxyphenyl)-2-(methylamino)ethanone x HCl Hydrochloride (Adrenalone Hydrochloride) HO

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Code Product Price Unit SO 3 H MM 0614.01 (1R)-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanesulphonic Acid H (A) 100 mg (Adrenaline  N

HO OH Alanine

MM 0566.00 Alanine NH2 (A) 500 mg OH O Albendazole

MM 0382.00 Albendazole H O (A) 500 mg N O NH S N MM 0382.01 Imp. A (EP): 5-(Propylsulphanyl)-1H-benzimidazol-2-amine H (A) 100 mg N NH2 S N MM 0382.02 Imp. B (EP): Methyl [5-Propylsulphinyl)-1H-benzimidazol- H O (A) 100 mg N O 2-yl]carbamate NH S N O O MM 0382.03 Imp. C (EP): Methyl [5-Propylsulphonyl)-1H-benzimidazol- H (A) 100 mg 2-yl]carbamate N O NH S N O O MM 0382.04 Imp. D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2-amine H (A) 100 mg N NH2 S N O O O MM 2500.00 Imp. E (EP): Methyl (1H-Benzimidazol-2-yl)carbamate H (A) 100 mg (Carbendazim) N O NH N Alfuzosin Hydrochloride MM 0085.04 Imp. B (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine O N Cl (A) 100 mg N O NH2 MM 1004.04 Imp. D (EP) as Dihydrochloride: (A) 50 mg O N N NH2 N-(4-Amino-6,7-dimethoxyquinazolin-2-yl)- x 2 HCl N-methylpropane-1,3-diamine Dihydrochloride N O NH2 Allobarbital MM 0899.00 Allobarbital [Controlled Substance] H (A) 100 mg O N O NH

O Allopurinol MM 0034.00 Allopurinol O (A) 500 mg NH N N N H MM 0034.01 Imp. A (EP) as Hemisulphate: 5-Amino-1H-pyrazole- O (A) 100 mg 4-carboxamide Hemisulphate NH2 1 N x /2 H2SO4 N NH2 H MM 0034.05 Imp. D (EP): Ethyl 5-Amino1H-pyrazole-4-carboxylate O (A) 100 mg O N N NH2 H MM 0034.06 Imp. E (EP): Ethyl 5-(Formylamino)-1H-pyrazole-4-carboxylate O (A) 100 mg O N N N O H H MM 0034.07 Oxypurinol O (A) 100 mg NH N N N O H H

26 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Alprazolam New MM 0136.00 Alprazolam [Controlled Substance] N (A) 100 mg N N

Cl N

MM 0028.03 Imp. E (EP): (2-Amino-5-chlorophenyl)phenylmethanone NH2 (B) 100 mg O Cl

Alverine Citrate MM 0454.00 Alverine Citrate O (A) 250 mg OH N OH x O OH OH O MM 0454.02 Imp. A (EP): 1-Chloro-3-phenyl-propane (A) 100 mg Cl MM 0454.03 Imp. B (EP): 3-Phenylpropan-1-ol (A) 100 mg OH MM 0454.04 Imp. C (EP) as Hydrochloride: N-Ethyl- (A) 100 mg x HCl 3-phenylpropan-1-amine Hydrochloride NH MM 0454.05 Imp. D (EP) as Hydrochloride: N-(3- (A) 100 mg x HCl Cyclohexylpropyl)-N-ethyl-3-phenyl- N propan-1-amine Hydrochloride MM 0454.06 Imp. E (EP) as Hydrochloride: 3-Phenyl- (A) 100 mg N,N-bis(3-phenylpropyl)propan-1-amine Hydrochloride x HCl

N Amantadine Hydrochloride MM 0564.00 Amantadine Hydrochloride NH2 (A) 500 mg x HCl

Ambroxol Hydrochloride MM 0005.00 Ambroxol Hydrochloride OH (A) 500 mg Br N x HCl H NH2 Br Br MM 0005.01 Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol OH (A) 100 mg NH2 Br MM 0005.04 Imp. B (EP) as Hydrochloride: trans-4-(6,8-Dibromo- OH (A) 100 mg 1,4-dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride Br N x HCl N Br H MM 0005.03 Imp. C (EP): trans-4-[[(E)-2-Amino- OH (A) 100 mg 3,5-dibromobenzyliden]amino]cyclohexanol Br N NH2 Br MM 0005.05 Imp. D (EP) as Hydrochloride: cis-4-[(2-Amino- OH (A) 100 mg 3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride Br N x HCl H NH2 Br MM 0005.02 Imp. E (EP): 2-Amino-3,5-dibromobenzaldehyde Br (A) 100 mg O NH2 Br MM 0005.06 trans-4-Aminocyclohexanol Hydrochloride OH (A) 100 mg x HCl H2 N

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Code Product Price Unit MM 0005.07 cis-4-Aminocyclohexanol Hydrochloride OH (A) 100 mg x HCl H2 N Amfetamine Sulfate

New MM 0741.00 Amfetamine Sulfate [Controlled Substance] NH2 (A) 100 mg x H2SO4 2 Amiloride Hydrochloride MM 0560.00 Amiloride Hydrochloride Dihydrate O NH (A) 500 mg Cl N N NH2 x HCl H x 2 H2O H2N N NH2 Aminocaproic Acid MM 0896.00 Aminocaproic Acid O (A) 500 mg H 2N OH Amiodarone Hydrochloride MM 0697.00 Amiodarone Hydrochloride O (A) 250 mg I O x HCl N O I MM 0697.11 Imp. A (EP) as Oxalate: O (A) 100 mg (2-Butylbenzofuran-3-yl)- HO O [4-[2-(diethylamino)ethoxy]- O x N phenyl]methanone Oxalate O HO O

MM 0697.03 Imp. B (EP) as Hydrochloride: O (D) 100 mg (2-Butylbenzofuran- I 3-yl)[4-[2-(ethylamino)ethoxy]-3,5- O H x HCl N diiodophenyl]methanone Hydrochloride O (Desethylamiodarone Hydrochloride) I

MM 0697.04 Imp. C (EP) as Hydrochloride: O (A) 100 mg (2-Butylbenzofuran- I 3-yl)[4-[2-(diethylamino)ethoxy]- O x HCl N 3-iodophenyl]methanone Hydrochloride O

MM 0697.05 Imp. D (EP): (2-Butylbenzofuran-3-yl) O (A) 100 mg (4-hydroxy-3,5-diiodophenyl)methanone I O OH I MM 0697.06 Imp. E (EP): (2-Butylbenzofuran- O (A) 100 mg 3-yl)(4-hydroxyphenyl)methanone O OH

MM 0697.07 Imp. F (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy- O (A) 100 mg 3-iodophenyl)methanone I O OH

MM 0697.09 Imp. H (EP) as Hydrochloride: 2-Chloro-N,N-diethylethanamine (C) 100 mg x HCl Hydrochloride (2-Chlorotriethylamine Hydrochloride; N (2-Chloroethyl)diethylamine Hydrochloride) Cl MM 0697.10 Amiodarone N-Oxide Hydrochloride O (A) 100 mg I O O x HCl N O I Amisulpride

MM 0051.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine H2N (A) 100 mg N

New MM 0793.02 Imp. B (EP): 4-Amino-N-[[(2RS)-1-ethyl- O O O (A) 50 mg S pyrrolidin-2-yl]methyl]-5-(ethylsulphonyl)- N 2-hydroxybenzamide H N H2N OH

28 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0793.03 Imp. C (EP): 4-Amino-N-[[(2RS)-1-ethyl-pyrrolidin- O (A) 50 mg I 2-yl]methyl]-5-iodo-2-methoxy-benzamide N H N H2N O

MM 0793.04 Imp. D (EP): 4-Amino-N-[[(2RS)-1-ethyl-pyrrolidin-2-yl]methyl]- O O O (A) 50 mg S 2-methoxy-5-(methylsulphonyl)benzamide N H N H2N O

MM 0793.05 Imp. E (EP): 4-Amino-5-(ethylsulphonyl)- O O O (A) 100 mg S 2-methoxybenzoic Acid OH

H2N O Amitraz MM 1018.01 Imp. A (BP): 2,4-Dimethylaniline NH2 (A) 100 mg (2,4-Xylidine)

MM 1018.02 Imp. B (BP): Form-2',4'-xylidide H (A) 100 mg N O

Amitriptyline Hydrochloride MM 0062.00 Amitriptyline Hydrochloride (A) 500 mg

N x HCl

MM 0062.01 Imp. A (EP): 10,11-Dihydro-5H-dibenzo- (B) 100 mg [a,d][7]annulen-5-one (Dibenzosuberone) O

MM 0062.02 Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo[a,d][7] (A) 100 mg annulen-5-ylidene)-N,N-dimethylpropan-1-amine N Hydrochloride (Cyclobenzaprine Hydrochloride) x HCl

MM 0079.00 Imp. C (EP) as Hydrochloride: 3-(10,11-Dihydro-5H- (A) 500 mg dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1- amine Hydrochloride (Nortriptyline Hydrochloride) N x HCl H

MM 0062.03 Imp. D (EP): 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H- (A) 100 mg OH dibenzo[a,d][7]annulen-5-ol N

MM 0062.05 Imp. F (EP): (5EZ,10RS)-5-[3-(Dimethyl-amino)propylidene]- (A) 100 mg 10,11-dihydro-5H-dibenzo[a,d][7]annulen-10-ol N

HO MM 0062.14 Imp. G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ol (A) 100 mg (Dibenzosuberol) OH

MM 0062.12 Amitriptyline N-Oxide Hydrochloride (B) 10 mg

N x HCl O

MM 0062.13 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene (Dibenzosuberane) (A) 100 mg

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Code Product Price Unit Amlodipine Besilate MM 0383.00 Amlodipine Besilate H (D) 100 mg N NH 2 O O O O O S OH O O Cl x

MM 0383.06 Amlodipine H (A) 100 mg N NH2 O O O O O Cl

MM 0383.01 Imp. A (EP): 3-Ethyl-5-Methyl (4RS)-4-(2-Chlorophenyl)- O (D) 100 mg 2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]- H N N 6-methyl-1,4-dihydropyridine-3,5-dicarboxylate O O O O O O Cl

MM 0383.02 Imp. B (EP): 3-Ethyl 5-Methyl (4RS)- H H (D) 100 mg N N O 4-(2-Chlorophenyl)-6-methyl- O O 2-[[2-[[2-(methylcarbamoyl)benzoyl]amino]- O O N ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate H O O Cl

MM 0383.03 Ethyl Methyl (4RS)-2,6-Bis[(2-aminoethoxy)methyl]- H (D) 100 mg H2N N NH2 4-(2-chlorophenyl)-1,4-dihydropyridine- O O 3,5-dicarboxylate Dihydrochloride O O O O Cl x 2 HCl

N NH2 MM 0383.04 Imp. D (EP): 3-Ethyl-5-Methyl 2-[(2-Aminoethoxy)methyl]- O (D) 100 mg 4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate O O O O Cl

MM 0383.10 Imp. E (EP): Diethyl (4RS)-2-[(2-Amino- H on request N NH2 ethoxy)methyl]-4-(2-chlorophenyl)-6- O methyl-1,4-dihydropyridine-3,5-dicarboxylate O O O O Cl

MM 0383.09 Imp. F (EP): Dimethyl (4RS)-2-[(2-Amino- H (D) 100 mg N NH2 ethoxy)methyl]-4-(2-chlorophenyl)-6- O methyl-1,4-dihydropyridine-3,5-dicarboxylate O O O O Cl

MM 0383.07 Imp. G (EP): Dimethyl 4-(2-Chlorophenyl)- H (A) 100 mg N 2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate O O

O O Cl

MM 0383.11 Imp. H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- (D) 100 mg H H 3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- N N methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- O O O O carbamoyl]benzoic Acid O OH O O Cl

MM 0383.05 Benzenesulfonic Acid O (B) 100 mg O S OH

Amlodipine Maleate MM 0631.00 Amlodipine Maleate H (D) 100 mg N NH2 O O O O OH x OH O O Cl O

30 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Amlodipine Mesilate MM 0592.00 Amlodipine Mesilate H (D) 100 mg N NH2 O O O O O x S O O HO Cl

Amobarbital New MM 1353.00 Amobarbital [Controlled Substance] H (A) 100 mg O N O NH

O

Amodiaquine Dihydrochloride Dihydrate MM 0617.00 Amodiaquine Dihydrochloride Dihydrate Cl N (A) 500 mg

N x 2 HCl HN x 2 H2O

OH MM 0617.01 4-Acetamido-2-diethylaminomethylphenol (A) 100 mg H N N O OH MM 0617.02 7-Chloro-4-(4-hydroxyphenylamino)quinoline Cl N (A) 100 mg

HN

OH MM0617.03 4,7-Dichloroquinoline Cl N (C) 100 mg

Cl MM 0617.04 Monodesethylamodiaquine Dihydrochloride Cl N (A) 100 mg

HN x 2 HCl HN

OH Amoxicillin Trihydrate O MM 0232.00 Amoxicillin Trihydrate OH (A) 500 mg O NH 2 N H x 3 H2O N S H O HO O MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- OH (B) 100 mg 7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O (6-Aminopenicillanic Acid) N S H2N H O MM 0232.02 Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino-2- OH (D) 100 mg (4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl- O NH2 N 7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane- H 2-carboxylic Acid (L-Amoxicillin) N S H O HO O MM 0232.03 Imp. C (EP): (4S)-2-[5-(4-Hydroxyphenyl)- OH (A) 100 mg 3,6-dioxopiperazin-2-yl]-5,5-dimethyl-thiazolidine- 4-carboxylic Acid HN H (Amoxicillin Diketopiperazines) O N S

N O H HO O MM 0232.04 Imp. D (EP) as Sodium Salt:(4S)-2-[[[(2R)-2-Amino- ONa (A) 100 mg 2-(4-hydroxyphenyl)acetyl]amino]carboxymethyl]- 5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt NH 2 HN H (Penicilloic Acids of Amoxicillin Sodium Salt) N S O HO HO O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 31 Table of content Pharmaceutical impurities

Code Product Price Unit O MM 0232.05 Imp. E (EP): (2RS,4S)-2-[[[(2R)-2-Amino- OH (A) 50 mg 2-(4-hydroxyphenyl)acetyl]amino]methyl]- 5,5-dimethylthiazolidine-4-carboxylic Acid NH 2 HN H (Penilloic Acids of Amoxicillin) N S O HO MM 0232.06 Imp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol HO N (A) 100 mg

N HO New MM 0232.07 Imp. G (EP): (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2- NH2 (A) 100 mg O Amino-2-(4-hydroxyphenyl)acetyl]amino]-2- O OH (4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl- O NH N 7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- HO H carboxylic Acid (D-(4-Hydroxyphenyl)- N S H glycylamoxicillin) O HO MM 0232.08 Imp. H (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2- O (A) 100 mg (4-hydroxyphenyl)acetic Acid NH OH

O HO MM 0232.09 Imp. I (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid NH 2 (B) 100 mg OH

O HO MM 0232.12 (2R)-2-Amino-2-(4-hydroxy-phenyl)-acetamide NH2 (A) 100 mg NH2 O HO Ampicillin Sodium O MM 0253.00 Ampicillin Sodium ONa (A) 500 mg O NH2 N H N S H O O MM 0253.15 Ampicillin Trihydrate OH (A) 500 mg O NH 2 N H x 3 H2O N S H O O MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo- OH (B) 100 mg 4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O (6-Aminopenicillanic Acid) N S H2N H O MM 0253.02 Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino- OH (A) 100 mg 2-phenylacetyl]amino]-3,3- O NH2 N dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- H carboxylic Acid N S (L-Ampicillin) H O

O MM 0253.03 Imp. C (EP): (4S)-2-(3,6-Dioxo-5-phenylpiperazin-2-yl)- OH (A) 100 mg 5,5-dimethylthiazolidine-4-carboxylic Acid (Diketopiperazines of Ampicillin) HN H O N S

N O H

O MM 0253.04 Imp. D (EP) as Sodium Salt: (4S)-2-[[[(2R)-2-Amino- ONa (A) 100 mg 2-phenylacetyl]amino]carboxymethyl]- NH2 HN 5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt H (Penicilloic Acids of Ampicillin Sodium Salt) N S O HO O O MM 0253.06 Imp. F (EP): (2RS,4S)-2-[[[(2R)-2-Amino- OH (A) 100 mg 2-phenylacetyl]amino]methyl]-5,5-dimethyl-thiazolidine- 4-carboxylic Acid (Penilloic Acids of Ampicillin) NH 2 HN H N S O MM 0253.08 Imp. H (EP): 3-Phenylpyrazin-2-ol HO N (A) 100 mg

N

32 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0253.11 Imp. K (EP): (2R)-2-[(2,2-Dimethylpropanoyl)-amino]-2- O (A) 100 mg phenylacetic Acid NH OH

O MM 0253.12 Imp. L (EP): (2R)-2-Amino-2-phenylacetic Acid NH 2 (B) 100 mg (D-Phenylglycine) OH O O MM 0253.16 Ampicillin, anhydrous OH (A) 500 mg O NH 2 N H N S H O MM 0565.00 Androstanolone OH (A) 250 mg

O Anise Oil

MM 0164.01 trans- (C) 100 mg O MM 0164.02 Estragole (C) 100 mg

O MM 0164.03 Anisaldehyde O (C) 100 mg O MM 0164.05 Linalol (C) 100 mg

HO

MM 0164.06 cis-Anethole (D) 100 mg

O Antazoline Hydrochloride MM 0171.00 Antazoline Hydrochloride (A) 500 mg N x HCl N N H MM 0171.01 Imp. A (EP) as Dihydrochloride: N-(2-Aminoethyl)- (A) 100 mg 2-(benzylphenylamino)acetamide Dihydrochloride O x 2 HCl N NH 2 N H MM 0171.04 Imp. B (Pharmeuropa) as Hydrochloride: 2-(Chloro- N (A) 100 mg x HCl methyl)-4,5-dihydro-1H-imidazole Hydrochloride N H Cl

MM 0171.03 N-Benzylaniline NH (B) 100 mg

Antazoline Phosphate

MM 0561.00 Antazoline Phosphate H (A) 500 mg N N N x H3PO4

Apomorphine Hydrochloride Hemihydrate

MM 0562.00 Apomorphine Hydrochloride Hemihydrate OH (A) 250 mg HO x HCl x ½ H2O N H MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: (A) 250 mg N Morphine Hydrochloride Trihydrate [Controlled Substance] x HCl x 3 H2O

HO O OH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 33 Table of content Pharmaceutical impurities

Code Product Price Unit Aprindine Hydrochloride MM 0467.00 Aprindine Hydrochloride on request N

N HCl

Arginine

MM 0568.00 Arginine H NH2 (A) 500 mg H2N N OH NH O Arginine Hydrochloride

MM 0569.00 Arginine Hydrochloride H NH2 (A) 500 mg H2N N OH x HCl NH O Aripiprazole New MM 0961.00 Aripiprazole (A) 100 mg

Cl N Cl N

O N O H Articaine Hydrochloride O MM 0369.00 Articaine Hydrochloride O (A) 100 mg H N x HCl N S H O MM 0369.01 Imp. A (EP) as Hydrochloride: Methyl O (A) 100 mg O H 3-[[2-(Propylamino)acetyl]amino]-4-methylthiophene- N x HCl N S 2-carboxylate Hydrochloride O H (Acetamidoarticaine Hydrochloride)

MM 0369.02 Imp. B (EP) as Hydrochloride: 4-Methyl-3-[[(2RS)- O (A) 50 mg HO H 2-(propylamino)propanoyl]amino]thiophene-2-carboxylic N x HCl N Acid Hydrochloride (Articaine Acid Hydrochloride) S H O

MM 0369.03 Imp. C (EP) as Hydrochloride: 1-Methylethyl 4-Methyl- O (A) 100 mg O H 3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene- N x HCl N 2-carboxylate Hydrochloride S H O (Articaine Isopropyl Ester Hydrochloride)

MM 0369.04 Imp. D (EP) as Hydrochloride: Methyl 3-[[(2RS)- O (B) 10 mg O H 2-(Ethylamino)propanoyl]amino]-4-methylthiophene- N x HCl N S 2-carboxylate Hydrochloride (Ethylarticaine Hydrochloride) O H

MM 0369.05 Imp. E (EP) as Hydrochloride: Methyl 4-Methyl-3-[[(2RS)- O (A) 100 mg O H 2-[(1-methylethyl)amino]propanoyl]amino]thiophene- N x HCl N S 2-carboxylate Hydrochloride O H (Isopropylarticaine Hydrochloride)

MM 0369.06 Imp. F (EP) as Hydrochloride: 4-Methyl-N-propyl- H O (A) 50 mg N H 3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene- N x HCl N 2-carboxamide Hydrochloride S H O (Articaine Acid Propionamide Hydrochloride)

MM 0369.07 Imp. G (EP) as Hydrochloride: Methyl 3-[[(2RS)- O (A) 100 mg O H 2-(Butylamino)propanoyl]amino]-4-methylthiophene- N x HCl N S 2-carboxylate Hydrochloride (Butylarticaine Hydrochloride) O H

MM 0369.08 Imp. H (EP) as Hydrochloride: Methyl 3-[[(2RS)- O (A) 100 mg O H 2-(Dipropylamino)propanoyl]amino]-4-methylthiophene- N x HCl N S 2-carboxylate Hydrochloride O (Dipropylarticaine Hydrochloride)

O MM 0369.09 Imp. I (EP): Methyl 3-Amino-4-methylthiophene-2-carboxylate O (C) 100 mg (3-Aminoarticaine) NH2 S

MM 0369.10 Imp. J (EP): Methyl 3-[[(2RS)-2-Bromopropanoyl]amino]- O (B) 10 mg O H 4-methylthiophene-2-carboxylate N Br S (Bromo Compound) O

34 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Ascorbic Acid

OH MM 0166.00 L-Ascorbic Acid HO (A) 500 mg O O HO OH Asparagine Monohydrate

MM 0765.01 Phenylacetylasparagine O (C) 50 mg

O HN OH H 2N O Aspartame

MM 0314.00 Aspartame O NH2 H O (A) 500 mg N HO O O

MM 0314.01 Imp. A (EP): 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid O (A) 100 mg (Diketopiperazine) O HN NH HO O MM 0314.02 Imp. B (EP): L-Aspartyl-L-phenylalanine O NH2 H O (A) 100 mg N HO OH O

MM 0314.03 Imp. C Aspartame (EP): Phenylalanine O (B) 100 mg H2N OH

Aspartic Acid

MM 0567.00 Aspartic Acid O NH2 (A) 500 mg OH HO O MM 0460.10 Imp. B (Pharmeuropa): (E)-Butenedioic Acid O (B) 100 mg HO (Fumaric Acid) OH O MM 0566.00 Imp. D (Pharmeuropa): (S)-2-Aminopropanoic NH2 (A) 500 mg Acid (Alanine) OH O MM 0169.00 Imp. F (Pharmeuropa): (2S)-2,5-Diamino-5- NH2 (A) 500 mg oxopentanoic Acid (L-Glutamine) H2N OH O O Astemizole MM 0184.00 Astemizole (A) 250 mg F HN N N N O

MM 0184.13 Desmethyl Astemizole Hydrochloride (B) 10 mg F HN N N N OH

x HCl Atenolol

OH MM 0013.00 Atenolol H (A) 500 mg O N O H2 N

OH MM 0013.03 Imp. A (EP): 2-(4-Hydroxyphenyl)acetamide O (B) 100 mg H2 N MM 0013.05 Imp. B (EP): 2-[4-[(2RS)- OH (A) 100 mg O OH 2,3-Dihydroxypropoxy)phenyl]acetamide O H2 N

O MM 0013.01 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]acetamide O (A) 100 mg O H2 N

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Code Product Price Unit MM 0013.06 Imp. D (EP): 2-[4-[(2RS)-3-Chloro- OH (A) 50 mg O Cl 2-hydroxypropoxy]phenyl]acetamide O H2 N MM 0013.07 Imp. E (EP): 2,2'-[(2-Hydroxypropane-1,3- OH (A) 50 mg O O diyl)bis(oxy-4,1-phenylene)]diacetamide O O H2 N NH2 Imp. F (EP): 2,2'-[[(1-Methylethyl)- MM 0013.02 OH OH (A) 50 mg imino]bis[(2-hydroxypropane-3,1- O N O diyl)oxy-4,1-phenylene]]diacetamide O O H2 N NH2

OH MM 0013.04 Imp. G (EP): 2-[4-[(2RS)-2-Hydroxy- H (A) 50 mg O N 3-[(1-methylethyl)amino]propoxy]phenyl]acetic Acid O HO OH MM 0013.08 Imp. H (EP): 2-[4-[(2RS)-2-Hydroxy- H (A) 100 mg 3-[(1-methylethyl)amino]propoxy]phenyl]acetonitrile O N N

OH MM 0013.17 Imp. I (EP): 2-[4-[(2RS)-3-(Ethylamino)-2- H (A) 50 mg O N hydroxypropoxy]phenyl]acetamide O

H2N OH MM 0013.13 4-Hydroxyphenylacetic Acid O (B) 100 mg HO Atorvastatin Trihydrate

MM 0400.00 Atorvastatin Calcium O (D) 100 mg - O OH O

N N OH H Ca2+

F 2

New MM 0400.11 Imp. D (EP): 3-[(4-Fluorophenyl)carbonyl]-2-(2- O (D) 100 mg methylpropanoyl)-N,3-diphenyloxirane-2-carbox- N O amide H O F O MM 0400.12 Imp. G (Pharmeuropa) as Calcium Salt: O (D) 100 mg (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4- - O OH O (phenylcarbamoyl)-5-(propan-2-yl)-1H- pyrrol-1-yl]-5-hydroxy-3-methoxyheptanoic N N O Acid Calcium Salt H Ca2+ (3-O-Methylatorvastatin Calcium Salt)

F 2 MM 0400.16 Imp. G (Pharmeuropa) as Lithium Salt: (3R,5R)-7- O (D) 100 mg [2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)- O OH OLi 5-(propan-2-yl)-1H-pyrrol-1-yl]-5-hydroxy-3-methoxy- heptanoic Acid Lithium Salt N N O H (3-O-Methylatorvastatin Lithium Salt)

F MM 0400.01 Imp. H (Pharmeuropa): (2R,4R)-2-[2-[2-(4-Fluoro- O (D) 100 mg phenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan- O O 2-yl)-1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2H- pyran-6-one N N OH H (Atorvastatin Lactone)

F MM 0400.04 1,1-Dimethylethyl (4R-cis)- (A) 100 mg 6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)- O O O O 3-phenyl-4-[(phenylamino)carbonyl]-1-H-pyrrol- N N O 1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate H

F MM 0400.05 1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2-dimethyl- (A) 100 mg 1,3-dioxane-4-acetate O O O

H2N O

36 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0400.13 1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]-ethyl]- O (A) 100 mg 5-(4-fluorophenyl)-2-(1-methylethyl)-N,4-diphenyl-1H- O O pyrrole-3-carboxamide (Atorvastatin eliminated Lactone) N N H

F Atracurium Besilate MM 0858.13 Imp. J (EP): Methyl Benzenesulphonate O O (A) 100 mg S O

Atropine MM 0289.18 Atropine H (A) 250 mg O H N O HOH and enantiomer MM 0289.00 Atropine Sulphate H (A) 500 mg O H x H2SO4 N x H2O O and enantiomer OH H 2 MM 0289.01 Imp. A (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl- H (D) 100 mg O 8-azabicyclo[3.2.1]oct-3-yl 2-Phenylpropenoate H N x HCl Hydrochloride O (Apoatropine Hydrochloride) H MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid O (A) 100 mg (Tropic Acid) OH

OH MM 0546.00 Imp. F (EP) as Hydrobromide Trihydrate: H H (A) 500 mg O Hyoscine Hydrobromide Trihydrate H x HBr N O O x 3 H2O H H OH MM 0289.03 Atropic Acid O (A) 100 mg

OH

Avobenzone MM 0902.00 Avobenzone O O (A) 500 mg

O

Azelaic Acid MM 0687.00 Azelaic Acid O O (A) 500 mg HO OH Azelastine Hydrochloride

MM 0362.00 Azelastine Hydrochloride O (A) 100 mg N N N x HCl

Cl MM 0362.04 Imp. A (EP): Benzoyldiazane O (C) 100 mg (Benzohydrazide) NH NH2 MM 0362.07 Imp. B (EP) as Dihydrochloride: 1-Benzoyl- (A) 100 mg H N 2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl] N x 2 HCl diazane Dihydrochloride N H O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 37 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0362.05 Imp. C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid O (A) 100 mg OH O

Cl MM 0362.01 Imp. D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one O (A) 100 mg NH N

Cl MM 0362.06 Imp. E (EP) Z-Isomer: (Z)-3-(4-Chlorobenzylidene)- O (A) 100 mg isobenzofuran-1(3H)-one O

Cl MM 0362.03 1-Methylazepan-4-one Hydrochloride (A) 100 mg N x HCl O Azithromycin MM 1075.00 Azithromycin (A) 100 mg N OH HO HO O O O N OH OO O O OH

MM 1075.01 Imp. A (EP): 6-Demethylazithromycin H (D) 100 mg N (Azaerythromycin A) OH HO HO OO O N OH OO O OH O

Baclofen MM 1235.03 Imp. B (EP): (3RS)-5-Amino-3-(4-chlorophenyl)- O (A) 100 mg 5-oxopentanoic Acid H2N O

OH

Cl MM 1235.01 3-(4-Chlorophenyl)glutaric Acid O (A) 100 mg HO O

OH

Cl Bambuterol Hydrochloride MM 0773.04 Imp. D (EP): 5-[(1RS)-1-Hydroxyethyl]-1,3-phenylene OH (A) 100 mg Bis(dimethylcarbamate) N O O

N O

O MM 0773.05 Imp. E (EP): 5-Acetyl-1,3-phenylene Bis-(dimethylcarbamate) O (A) 100 mg N O

O

N O

O Basic Butylated Methacrylate Copolymer

MM 0753.01 Imp. A (EP): Butyl Methacrylate O (A) 100 mg O

MM 0753.02 Imp. B (EP): Methyl Methacrylate O (A) 100 mg O

38 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0753.03 Imp. C (EP): 2-(Dimethylamino)ethyl Methacrylate O (A) 100 mg N O

Beclometasone Dipropionate MM 0199.00 Dipropionate O (A) 250 mg O O O HO O

Cl O MM 0199.02 Imp. A (EP): 9-Chloro- -dihydroxy- - O (A) 100 mg O methyl-3,20-dioxopregna-1,4-dien-21-yl O Propanoate (Beclometasone 21-Propionate) HO OH

Cl O MM 0199.06 Imp. B (EP): 21-(Acetyloxy)-9-chloro- - O (A) 100 mg hydroxy- -methyl-3,20-dioxopregna-1,4- O O O dien-17-yl Propanoate (Beclometasone 21-Acetate 17-Propionate) HO O

Cl O MM 0199.05 Imp. C (EP): 9-Chloro- -hydroxy- -methyl- O (A) 100 mg 3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien- O O O 21-yl Butanoate (Beclometasone 21-Butyrate 17-Propionate) HO O

Cl O OH MM 0199.01 Imp. H (EP): 9-Chloro- -dihydroxy- - O (A) 100 mg O methyl-3,20-dioxopregna-1,4-dien-17-yl Propanoate HO O (Beclometasone 17-Propionate) Cl O 9-Chloro- -trihydroxy- -methylpregna- OH MM 0199.03 O (A) 100 mg 1,4-diene-3,20-dione (Beclometasone) HO OH

Cl O Benazepril Hydrochloride

MM 1229.00 Benazepril Hydrochloride O (A) 100 mg H OH N N x HCl O O O

Bendroflumethiazide

MM 0674.01 Imp. A (EP): 4-Amino-6-(trifluoromethyl)benzene- OO O O (A) 100 mg H2N S S 1,3-disulphonamide NH2 F NH2 F F Benfluorex Hydrochloride O New MM 1298.01 Imp. A (EP) as Hydrochloride: 2-[[(1RS)- H (A) 50 mg N 1-Methyl-2-[2-(trifluoromethyl)phenyl] O ethyl]amino]ethyl Benzoate Hydrochloride F x HCl F F O New MM 1298.02 Imp. B (EP) as Hydrochloride: 2-[[(1RS)-1- H (A) 50 mg N Methyl-2-[4-(trifluoromethyl)phenyl]ethyl]- O x HCl amino]ethyl Benzoate Hydrochloride F F F MM 0278.01 Imp. C (EP): Benzoic Acid O (B) 100 mg HO

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 39 Table of content Pharmaceutical impurities

Code Product Price Unit New MM 1298.05 Imp. E (EP): N-(2-Hydroxyethyl)-N-[(1RS)-1-methyl- (A) 50 mg 2-[3-(trifluoromethyl)phenyl]ethyl]benzamide O

N OH

F F F New MM1298.06 Imp. F (EP): 2-[Benzoyl[(1RS)-1-methyl-2-[3-(tri- (A) 50 mg fluoromethyl)phenyl]ethyl]amino]ethyl Benzoate O O N O

F F F Benperidol MM 0113.00 Benperidol O (A) 100 mg NH N O N

F MM 0113.03 Imp. A (EP): 1-(Piperidin-4-yl)-1,3-dihydro-2H- O (A) 100 mg benzimidazol-2-one NH N

HN MM 0113.07 4-Chloro-4'-fluorobutyrophenone O (B) 100 mg Cl

F Benzalkonium Chloride

MM 0224.00 Benzalkonium Chloride Cl (A) 500 mg N n MM 0795.00 Imp. A (EP): Benzyl Alcohol (A) 500 mg OH

MM 0224.01 Benzyldimethyldodecylammonium Chloride Cl (A) 500 mg N 5

MM 0224.02 Benzyldimethyltetradecylammonium Chloride Cl (A) 500 mg N 6

MM 0224.03 Benzyldimethylhexadecylammonium Chloride Cl (A) 500 mg N 7 Benzbromarone MM 0456.00 Benzbromarone O (A) 500 mg Br O OH Br Benzocaine MM 0094.00 Benzocaine O (A) 500 mg O

H2N MM 0094.01 Benzocaine Acetylsalicylamide O (C) 50 mg O O

N H O

O MM 0094.02 N-Acetylbenzocaine O (A) 100 mg O O

N H MM 0094.03 4-Aminobenzoic Acid O (B) 100 mg OH

H2N

40 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0094.04 Ethyl 4-Nitrobenzoate O (B) 100 mg O

O 2N Benzydamine Hydrochloride MM 0142.00 Benzydamine Hydrochloride (A) 500 mg N N x HCl O N

MM 0142.04 Imp. C (BP): 1-Benzyl-1H-indazol-3-ol (A) 100 mg N N

OH MM 0142.08 Benzydamine N-Oxide Hydrochloride (A) 100 mg N N x HCl

O N O MM 0290.02 1-Chloropropyl(dimethyl)amine Hydrochloride (B) 100 mg Cl N x HCl (N,N-Dimethyl-3-chloropropylamine Hydrochloride) Benzyl Alcohol MM 0795.00 Benzyl Alcohol (A) 500 mg OH

MM 0795.02 Imp. B (EP): Cyclohexylmethanol OH (A) 100 mg

Benzyl Benzoate MM 0570.00 Benzyl Benzoate O (A) 500 mg O

Benzyl Nicotinate MM 0104.00 Benzyl Nicotinate O (A) 500 mg N O

MM 0553.00 Nicotinic Acid O (A) 500 mg N OH

Benzylpenicillin Benzathine MM 0513.00 Benzylpenicillin Benzathine O (A) 500 mg OH H O N N x H N S N H H O 2

NH2 MM 0513.02 Imp. A (EP): Monobenzylethylendiamine HN (C) 100 mg

MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] OH (B) 100 mg O MM 0160.07 Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7a- O (A) 100 mg OH tetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid N (Penillic Acid of Benzylpenicillin) N S H HO O MM 0160.01 Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]- O (A) 100 mg OH 5,5-dimethylthiazolidine-4-carboxylic Acid HN (Penicilloic Acids of Benzylpenicillin) H N S O O OH O MM 0160.05 Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]- OH (A) 100 mg 5,5-dimethylthiazolidine-4-carboxylic Acid HN (Penilloic Acids of Benzylpenicillin) H N S O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 41 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0513.01 N,N’-Dibenzylethylenediamine Diacetate (C) 100 mg H N O x HO N 2 H

Benzylpenicillin Potassium

MM 0160.00 Benzylpenicillin Potassium O (A) 250 mg OK O O N N S H H MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia- O (B) 100 mg OH 1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O N (6-Aminopenicillanic Acid) H2 N S H

MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] O (B) 100 mg OH MM 0160.07 Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7a- O (A) 100 mg OH tetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid N (Penillic Acid of Benzylpenicillin) N S H HO O MM 0160.01 Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]- O (A) 100 mg OH 5,5-dimethyl-thiazolidine-4-carboxylic Acid HN (Penicilloic Acids of Benzylpenicillin) H N S O O OH MM 0160.05 O (A) 100 mg Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]- OH 5,5-dimethylthiazolidine-4-carboxylic Acid HN (Penilloic Acids of Benzylpenicillin) H N S O Benzylpenicillin Procaine MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid O (B) 100 mg OH

H2N O MM 0160.01 Imp. B (EP): (4S)-2-[Carboxy[(phenyl-acetyl)amino]methyl]- OH (A) 100 mg 5,5-dimethyl-thiazolidine-4-carboxylic Acid HN (Penicilloic Acids of Benzylpenicillin) H N S O O OH O MM 0160.05 Imp. C (EP): (2RS,4S)-2-[[(Phenylacetyl)-amino]methyl]- OH (A) 100 mg 5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin) HN H N S O MM 0160.07 O (A) 100 mg Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7a- OH tetrahydroimidazo[5,1-b]thiazole-3,7-dicarboxylic Acid N (Penillic Acid of Benzylpenicillin) N S H HO O MM 0160.03 Imp. E (EP): Phenylacetic Acid [Drug Precursor] OH (B) 100 mg O Betahistine Dihydrochloride MM 0587.00 Betahistine Dihydrochloride H (A) 500 mg N N x 2 HCl

MM 0587.01 Imp. A (EP): 2-Ethenylpyridine (2-Vinylpyridine) N (C) 100 mg

MM 0587.02 Imp. B (EP): 2-(Pyridin-2-yl)ethanol (2-(2-Hydroxyethyl)pyridine) N OH (B) 100 mg

MM 0587.03 Imp. C (EP) as Trihydrochloride: N-Methyl-2-(pyridin- (A) 100 mg N N N 2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine Trihydrochloride x 3 HCl

MM 0587.04 Imp. C (EP) as Trimesilate: N-Methyl-2-(pyridin-2-yl)- (A) 100 mg N N N O O N-[2-(pyridin-2-yl)ethyl]ethanamine Trimesilate x3 S OH

42 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Betaine Hydrochloride MM 0611.00 Betaine Hydrochloride O (A) 500 mg N Cl OH MM 0200.00 Betamethasone O (A) 250 mg OH HO OH

F O MM 0213.00 Imp. A (EP): O (A) 250 mg OH HO OH

F O MM 0200.01 Imp. B (EP): 21-Chloro-9-fluoro- -dihydroxy- - O (A) 100 mg Cl methylpregna-1,4-diene-3,20-dione () HO OH

F O MM 0201.00 Betamethasone Acetate O (A) 250 mg O O HO OH

F O O MM 0200.00 Imp. A (EP): Betamethasone OH (A) 250 mg HO OH

F O MM 0445.00 Imp. B (EP): O (A) 250 mg O O HO OH

F O O MM 0201.03 Imp. C (EP): Betamethasone 11,21-Diacetate O O (A) 100 mg O O OH

F O Betamethasone Dipropionate

OH MM 0200.00 Imp. A (Pharmeuropa): 9-Fluoro- - O (A) 250 mg trihydroxy- -methylpregna-1,4-diene-3,20- HO dione (Betamethasone) OH

F O MM 0202.00 Betamethasone Dipropionate O (A) 250 mg O O O HO O

F O MM 0202.04 Imp. C (Pharmeuropa): 9-Fluoro- -dihydroxy- O (A) 100 mg O -methyl-3,20-dioxopregna-1,4-dien-21-yl Propanoate O (Betamethasone 21-Propionate) HO OH

F O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 43 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0199.00 Imp. E (Pharmeuropa): 9-Chloro- -hydroxy- O (A) 250 mg -methyl-3,20-dioxopregna-1,4-diene-17,21- O O O diyl Dipropanoate (Beclometasone Dipropionate) HO O

Cl O Betamethasone Sodium Phosphate MM 0303.00 Betamethasone Sodium Phosphate O (A) 250 mg O P ONa ONa O HO OH

F O Betamethasone 17-Valerate MM 0203.00 Betamethasone 17-Valerate OH (A) 250 mg O O HO O

F O OH MM 0200.00 Imp. A (EP): Betamethasone O (A) 250 mg

HO OH

F O Betaxolol Hydrochloride

OH MM 0436.01 Imp. A (EP) as Hydrochloride: (2RS)- H (A) 50 mg O 1-(4-Ethylphenoxy)-3-[(1-methylethyl)amino]- N x HCl propan-2-ol Hydrochloride Imp. B (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]- OH MM 0027.10 3-[(1-methylethyl)amino]propan-2-ol H (A) 100 mg O N

HO MM 0436.03 Imp. C (EP): 2-[[4-[2-(Cyclopropylmethoxy)- O (A) 50 mg O ethyl]phenoxy]methyl]oxirane O

MM 0436.04 Imp. D (EP): 4-[2-(Cyclopropylmethoxy)ethyl]phenol OH (A) 50 mg

O

OH MM 0436.05 Imp. E (EP) as Hydrochloride: (2RS)- H (A) 50 mg 1-[4-(2-Butoxyethyl)phenoxy]- O N 3-[(1-methylethyl)amino]propan-2-ol Hydrochloride O x HCl OH MM 0436.06 1-[4-(2-Cyclobutoxyethyl)phenoxy]- H (D) 50 mg 3-(isopropylamino)propan-2-ol Hydrochloride O N

O x HCl Bezafibrate MM 0063.00 Bezafibrate O (A) 500 mg O O OH N H Cl OH MM 0063.01 Imp. A (EP): 4-Chloro-N-[2-(4-hydroxyphenyl)ethyl] O (A) 100 mg benzamide (4-Chlorobenzoyltyramine) N H Cl MM 0063.03 Imp. B (EP): 4-Chlorobenzoic Acid O (B) 100 mg OH Cl MM 0063.04 Imp. C (EP): Methyl- O (A) 100 mg O 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]- O O 2-methylpropanoate N H Cl

44 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0063.02 Imp. D (EP): Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]- O (A) 100 mg O ethyl]phenoxy]-2-methylpropanoate O O N H Cl MM 0063.05 Imp. E (EP): Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]- O (A) 100 mg O ethyl]phenoxy]-2-methylpropanoate O O N H Cl MM 0063.06 Tyramine OH (B) 100 mg

H2 N MM 0063.07 N,O-Bis-(4-chlorobenzoyl)tyramine Cl (A) 100 mg O O O N H Cl N MM 0894.00 Bicalutamide F (A) 100 mg O F S N O O OH H F F MM 0894.01 N-[4-Cyano-3-(trifluoromethyl)phenyl]- O HO F F (A) 50 mg S H N 3-[(4-fluorophenyl)sulfinyl]-2-hydroxy- F 2-methylpropanamide O F N Bifonazole MM 0318.00 Bifonazole (A) 500 mg

N N MM 0318.01 Imp. A (EP): (RS)-(Biphenyl-4-yl)phenylmethanol (A) 100 mg

OH MM 0015.02 Imp. C (EP): 1H-Imidazole (Imidazole) H (B) 100 mg N N MM 0318.03 Imp. D (EP) as Chloride: 1,3-Bis[(biphenyl-4-yl)- (D) 100 mg phenylmethyl]-1H-imidazolium Chloride

N+ Cl- N

Bisacodyl MM 0031.00 Bisacodyl O O (A) 500 mg O O

N

MM 0031.01 Imp. A (EP): 4,4'-(Pyridin-2-ylmethylene)diphenol HO OH (A) 100 mg

N

MM 0031.04 Imp. B (EP): 2-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl) OH OH (A) 50 mg methyl]phenol

N

MM 0031.02 Imp. C (EP): 4-[(RS)-(4-Hydroxyphenyl)(pyridin- HO O (A) 100 mg 2-yl)methyl]phenyl Acetate O

N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 45 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0031.03 Imp. E (EP): 2-[(RS)-[4-(Acetyloxy)phenyl](pyridin- O (A) 50 mg 2-yl)methyl]phenyl Acetate O O

O

N

HO O ONa MM 0054.01 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)-methyl]phenyl S (A) 100 mg Sodium Sulphate O O (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl Sodium Sulphate) N

NaO O MM 0054.02 2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)- S (D) 50 mg phenyl]methyl]phenyl Disodium Sulphate O O (2,4'-[(Pyridin-2-yl)methylene]bisphenyl Bis (Sodium Sulphate)) O ONa N S O O

Bisoprolol Fumarate

MM 0460.00 Bisoprolol OH H (A) 100 mg O N O O MM 0460.08 Bisoprolol Fumarate OH OH (A) 100 mg H O N O x O O O 2 HO OH MM 0460.01 Imp. A (EP): (RS)-1-(4-Hydroxymethyl- H (A) 100 mg phenoxy)-3-isopropylaminopropan-2-ol O N

OH OH MM 0460.07 Imp. B (EP): (RS)-1-Isopropylamino-3-[4-(2- H (A) 100 mg propoxyethoxymethyl)phenoxy]propan-2-ol O N

O O OH OH MM 0460.15 Imp. C (EP): (RS)-1-[4-[4-(2-Hydroxy- H H (A) 100 mg 3-isopropylaminopropoxy)benzyl]- N O O N phenoxy]-3-isopropylaminopropan-2-ol

OH MM 0460.21 Imp. G (EP): (2RS)-1-[4-[[(2-Isopropoxy- H (D) 100 mg ethoxy)methoxy]methyl]phenoxy]-3-iso- O N propylaminopropan-2-ol

O O O MM 0460.24 Imp. J (Pharmeuropa): (2RS)-3-[4-((2-Isopropoxy- OH (A) 100 mg O OH ethoxy)methyl)phenoxy]-1,2-propanediol O O OH MM 0460.18 Imp. K (EP): 2-Isopropoxyethyl 4-[[(2RS)- H (A) 100 mg O N 2-Hydroxy-3-(isopropylamino)propyl]oxy]- O benzoate (Bisoprolol Ester) O

O Imp. L (EP) as Hydrochloride: 4-[[(2RS)-2-Hydroxy- OH MM 0027.24 H (A) 100 mg 3-(isopropylamino)propyl]oxy]benzaldehyde O N Hydrochloride x HCl (4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]- benzaldehyde Hydrochloride) O Imp. M (Pharmeuropa): 4-[(2-Isopropoxyethoxy) MM 0460.02 methyl]phenol (A) 100 mg OH O O OH MM 0460.25 Imp. N (EP): [(2RS)-1-[4-[(2-Ethoxyethoxy)- H (A) 100 mg O N methyl]phenoxy]-3-isopropylaminopropan-2-ol O O OH MM 0460.05 Imp. Q (EP): (2RS)-1-(Isopropylamino)-3-[4-(2- H (A) 100 mg O N methoxyethoxy)methyl]phenoxypropan-2-ol O O OH MM 0460.28 Imp. R (EP): (2RS)-1-(Isopropylamino)-3-(4- H (A) 50 mg methylphenoxy)propan-2-ol O N

46 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0460.14 Imp. S (EP): 4-Hydroxybenzaldehyde OH (C) 100 mg O MM 0460.17 Imp. T (EP): 4-[(3-Isopropyl-2-oxo-1,3-oxazolidin-5- O (A) 50 mg yl)methoxy]benzaldehyde (Bisoprolol Oxazolidinone- O N benzaldehyde) O

O MM 0460.16 Imp. U (EP): 5-[[4-(Hydroxymethyl)phenoxy]- O (A) 50 mg methyl]-3-isopropyl-1,3-oxazolidin-2-one O N (Bisoprolol Oxazolidinonebenzylalcohol) O HO OH MM 0460.27 (2RS)-4-[2-Hydroxy-3-(isopropylamino)propoxy]- H (A) 50 mg benzoic Acid Hydrochloride O N x HCl HO

O O MM 0460.03 2-[4-(2-Isopropoxyethoxymethyl)phenoxymethyl]oxirane O (A) 100 mg O O MM 0460.06 4-Hydroxybenzyl Alcohol OH (B) 100 mg HO MM 0460.10 Fumaric Acid O (B) 100 mg HO OH O OH MM 0460.23 (2RS)-1-[4-((2-Hydroxyethoxy)methyl)phenoxy]- H (A) 50 mg O N 3-(isopropylamino)-2-propanol HO O MM 0864.00 Boldenone OH (A) 100 mg

O Brimonidine Tartrate

N OH O MM 1324.00 Brimonidine Tartrate N (A) 100 mg x HO OH N N N H H O OH Br Bromazepam MM 0064.00 Bromazepam [Controlled Substance] H O (A) 100 mg N

Br N N

MM 0064.01 Imp. A (EP): (2-Amino-5-bromophenyl)(pyridin-2-yl)methanone NH2 (A) 100 mg O Br N

O MM 0064.02 Imp. B (EP): N-[4-Bromo-2-(pyridin-2- Cl (A) 50 mg ylcarbonyl)phenyl]-2-chloroacetamide NH

O Br

N

MM 0064.09 Imp. C (EP): 7-Bromo-5-(6-methylpyridin-2-yl)-1,3-dihydro-2H- H O (A) 50 mg N 1,4-benzodiazepin-2-one Br N N

MM 0064.04 Imp. D (EP): 3-Amino-6-bromo-4-(pyridin- H (A) 50 mg N O 2-yl)quinolin-2(1H)-one

Br NH2

N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 47 Table of content Pharmaceutical impurities

Code Product Price Unit O MM 0064.07 Imp. E (EP): 2-Bromo-N-[4-bromo-2-(pyridin- Br (A) 50 mg 2-ylcarbonyl)phenyl]acetamide NH

O Br

N

Bromhexine Hydrochloride MM 0065.00 Bromhexine Hydrochloride Br (A) 500 mg

N x HCl Br NH 2

Br MM 0005.01 Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol OH (A) 100 mg NH2 Br MM 0005.02 Imp. B (EP): 2-Amino-3,5-dibromobenzaldehyde Br (A) 100 mg O NH2 Br MM 0065.02 Imp. C (EP): N-(2-Aminobenzyl)-N-methylcyclohexanamine (A) 100 mg N

NH 2 MM 0065.03 Imp. D (EP) as Dihydrochloride: N-(2-Amino-5-bromobenzyl)-N- Br (A) 100 mg methylcyclohexanamine Dihydrochloride x 2 HCl N NH2

MM 0065.01 N-(2-Nitrobenzyl)-N-cyclohexyl-N-methylamine (A) 100 mg N NO2 MM 0065.05 6,8-Dibromo-3-cyclohexyl-3,4-dihydro-2(1H)-quinazolinone Br (A) 100 mg

Br HN N

O MM 0065.09 Bromhexine N-Oxide Br (A) 100 mg

N Br O NH2 Bromisoval MM 1128.01 Ethyl 2-Bromoisovalerate O (A) 100 mg O Br Brompheniramine Maleate

MM 0060.00 Brompheniramine Maleate O (A) 500 mg N OH x OH N O Br MM 0090.00 Imp. A (EP) as Maleate: Chlorphenamine Maleate O (A) 500 mg N OH x OH N O Cl MM 1114.00 Imp. B (EP) as Maleate: Dexchlorpheniramine Maleate O (A) 100 mg N OH x OH N O Cl MM 0059.01 Imp. C (EP): (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)- (A) 100 mg propan-1-amine (Pheniramine) N

N

48 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0059.00 Imp. C (EP) as Maleate: (3RS)-N,N-Dimethyl- O (A) 100 mg 3-phenyl-3-(pyridin-2-yl)propan-1-amine Maleate N OH (Pheniramine Maleate) x OH N O MM 0060.12 Brompheniramine N-Oxide on request N

N O Br

MM 0060.16 Desmethylbrompheniramine Maleate O (A) 100 mg N OH x OH N H O Br Buclizine Hydrochloride MM 0380.04 Imp. A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine (A) 100 mg (1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine)

Cl N N Cl

MM 0380.09 4-Chlorobenzhydrol Cl (B) 100 mg OH

MM 0380.10 4-Chlorobenzophenone Cl (B) 100 mg O

Cl MM 0380.01 1-(4-Chlorobenzhydryl)piperazine((RS)- NH (A) 100 mg 1-[(4-Chlorophenyl)phenylmethyl]piperazine) N

Budesonide MM 0204.01 Imp. A -Tetrahydroxy- O (A) 100 mg pregna-1,4-diene-3,20-dione HO OH OH -Hydroxy-) OH

O OH MM 0204.02 Imp. B -[(1RS)-Ethylidenebis(oxy)]- O (A) 50 mg -dihydroxypregna-1,4-diene-3,20-dione HO O O

O OH New MM 0204.07 Imp. G -[(1RS)-Butylidenebis(oxy)]- O (A) 50 mg -dihydroxypregn-4-ene-3,20-dione HO O (1,2-Dihydrobudesonide) O

O OH New MM 0204.12 Imp. H -[(1RS)-Butylidenebis(oxy)]- O (A) 50 mg 21-hydroxypregna-1,4,9(11)-triene-3,20-dione O O

O OH New MM 0204.13 Imp. I -Trihydroxy-3,20-dioxopregna- O (A) 50 mg 1,4-dien- -yl Butanoate HO OH O

O O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 49 Table of content Pharmaceutical impurities

Code Product Price Unit OH New MM 0204.14 Imp. J -[(1RS)-Butylidenebis(oxy)]- - O (A) 50 mg bromo- -dihydroxypregna-1,4-diene-3,20-dione HO O O

Br O Bufexamac

MM 0179.00 Bufexamac H (A) 500 mg N OH O O MM 0179.01 Imp. A (EP): 2-(4-Butoxyphenyl)acetic Acid OH (A) 100 mg O O MM 0179.02 Imp. B (EP): Methyl 2-(4-Butoxyphenyl)acetate O (A) 100 mg O O MM 0179.03 Imp. C (EP): Butyl 2-(4-Butoxyphenyl)acetate O (A) 100 mg O O MM 0179.04 Imp. D (EP): 2-(4-Butoxyphenyl)acetamide NH2 (A) 100 mg O O MM 0179.05 4'-Butoxyacetophenone O (A) 100 mg

O MM 0179.06 Ethyl 2-(4-Butoxyphenyl)acetate O on request O O Buflomedil Hydrochloride

MM 0066.00 Buflomedil Hydrochloride O O (A) 500 mg N x HCl O O MM 0066.01 Imp. A (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)-1- OH O (A) 100 mg (2-hydroxy-4,6-dimethoxyphenyl)butan-1-one Hydrochloride N (o-Desmethyl-Buflomedil Hydrochloride) x HCl O O

MM 0066.02 Imp. B (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)- O O (A) 100 mg 1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one Hydrochloride N (p-Desmethyl-Buflomedil Hydrochloride) x HCl HO O MM 0066.03 4-(1-Pyrrolidino)butyronitrile (C) 100 mg N N

MM 0066.05 1,3,5-Trimethoxybenzene O (C) 100 mg

O O Bunolol Hydrochloride

MM 0642.00 Bunolol Hydrochloride OH (A) 100 mg H O N O x HCl

Buphenine Hydrochloride MM 0710.00 Buphenine Hydrochloride OH (A) 500 mg

x HCl HN HO

Bupivacaine Hydrochloride MM 0613.00 Bupivacaine Hydrochloride Monohydrate (A) 500 mg H x HCl N N x H2O O MM 0368.03 Imp. A (EP): N-(2,6-Dimethylphenyl)pyridine- (A) 100 mg H 2-carboxamide N N O

MM 0613.05 Imp. E (EP) as Hydrochloride: 6-(Butylamino)-N- H (A) 50 mg N (2,6-dimethylphenyl)hexanamide Hydrochloride N H O x HCl MM 0102.02 Imp. F (EP): 2,6-Dimethylaniline (B) 100 mg NH2

50 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0613.07 Bupivacaine N-Oxide (A) 100 mg H N N O O Buprenorphine

New MM 0120.00 Buprenorphine [Controlled Substance] N (A) 100 mg

OH

H HO O O Bupropion Hydrochloride

O MM 0745.00 Bupropion Hydrochloride H (A) 100 mg Cl N x HCl

O MM 0745.02 2-(tert-Butylamino)-4'-chloropropiophenone Hydrochloride H (A) 100 mg N x HCl Cl

O MM 0745.03 2-(tert-Butylamino)-3'-bromopropiophenone Hydrochloride H (A) 100 mg Br N x HCl

O MM 0745.05 2-(tert-Butylamino)propiophenone Hydrochloride H (A) 100 mg N x HCl

MM 0745.07 1-(3-Chlorophenyl)-1-hydroxy-2-propanone OH (D) 100 mg Cl O

MM 0745.08 3-Chloropropiophenone O (B) 100 mg Cl

New MM 0745.14 Hydroxybupropion (as (RS,RS)-cyclic Hemiketal) (A) 100 mg O HO Cl NH

and Enantiomer Buspirone Hydrochloride

MM 0464.00 Buspirone Hydrochloride O N (A) 500 mg N N N x HCl N O

MM 0464.02 Imp. A (EP) as Dihydrochloride: 2-(Piperazin- HN (A) 100 mg 1-yl)pyrimidine Dihydrochloride N N x 2 HCl N

MM 0464.04 Imp. C (EP): 2,2'-[Butane- N (A) 50 mg 1,4-diylbis(piperazine- N N 1,4-diyl)]dipyrimidine N N N N

N New MM 0464.19 Imp. E (EP) as Hydrochloride: [1-[2-Oxo-2-[[4-[4- (A) 50 mg O (pyrimidin-2-yl)piperazin-1-yl]butyl]amino]ethyl]- cyclopentyl]acetic Acid Hydrochloride O HN N OH N N x HCl N New MM 0464.20 Imp. F (EP) as Dioxalate: 4-[4-(Pyrimidin-2-yl)- (A) 50 mg O piperazin-1-yl]butyl [1-[2-Oxo-2-[[4-[4-(pyrimidin- 2-yl)piperazin-1-yl]butyl]amino]ethyl]cyclopentyl]- O HN N acetate Dioxalate O N N N N N N O OH x2 N O OH MM 0464.12 Imp. G (EP): 2,2'-(Piperazine-1,4-diyl)dipyrimidine N (A) 50 mg

N N N N

N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 51 Table of content

Pharmaceutical impurities

Code Product Price Unit Butalbital MM 0899.00 5,5-Diallybarbituric acid (Allobarbital) H (A) 100 mg O N O [Controlled Substance] NH

O Butetamate Citrate MM 0606.00 Butetamate Citrate O (A) 500 mg OH OH x O O N OH O OH O Butorphanol Tartrate New MM 1192.00 Butorphanol Tartrate (A) 100 mg N OH O x HO HO OH O OH

HO Butyl Parahydroxybenzoate MM 0496.00 Butyl Parahydroxybenzoate O (A) 500 mg O HO MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg OH HO MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate O (A) 500 mg (Methyl Parahydroxybenzoate) O

HO MM 0498.00 Imp. C (EP): Ethyl 4-Hydroxybenzoate O (A) 500 mg (Ethyl Parahydroxybenzoate) O HO MM 0432.00 Imp. D (EP): Propyl 4-Hydroxybenzoate O (A) 500 mg (Propyl Parahydroxybenzoate) O HO MM 0496.05 Imp. E (Pharmeuropa): 2-Methylpropyl 4- O (A) 100 mg Hydroxybenzoate (Isobutyl Parahydroxybenzoate) O

HO

Butylhydroxytoluene MM 0679.00 Butylhydroxytoluene (A) 500 mg OH

Caffeine MM 0494.00 Caffeine O (A) 500 mg N N O N N

O MM 0176.00 Imp. A (EP): Theophylline H (A) 500 mg N N O N N

MM 0176.02 Imp. B (EP): N-(6-Amino-1,3-dimethyl-2,4-dioxo- O H (A) 100 mg N O 1,2,3,4-tetrahydropyrimidin-5-yl)formamide N

O N NH2

MM 0494.03 Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro- O (A) 50 mg 1H-purine-2,6-dione (Isocaffeine) N N O N N

52 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Butylhydroxytoluene MM 0679.00 Butylhydroxytoluene (A) 500 mg OH

Caffeine MM 0494.00 Caffeine O (A) 500 mg N N O N N

O MM 0176.00 Imp. A (EP): Theophylline H (A) 500 mg N N O N N

MM 0176.02 Imp. B (EP): N-(6-Amino-1,3-dimethyl-2,4-dioxo- O H (A) 100 mg N O 1,2,3,4-tetrahydropyrimidin-5-yl)formamide N

O N NH2

MM 0494.03 Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro- O (A) 50 mg N 1H-purine-2,6-dione (Isocaffeine) N O N N

MM 0577.00 Imp. D (EP): Theobromine O (A) 500 mg N HN

O N N

MM 0494.06 Imp. E (EP) as Nitrate: N,1-Dimethyl-4- O (A) 100 mg N (methylamino)-1H-imidazole-5-carbox- N x HNO3 amide Nitrate (Caffeidine Nitrate) H HN N

MM 0494.04 Imp. F (EP): 1,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione O (D) 50 mg N (Paraxanthine; 1,7-Dimethylxanthine) N

O N N H New MM 0494.10 Sodium 4-[N-Methyl-N-(N-methylaminocarbonyl)amino]- O (A) 50 mg N 1-methylimidazole-5-carboxylate NaO

N N

HN O

Candesartan Cilexetil MM 0776.00 Candesartan Cilexetil (A) 100 mg O O O O O N N N NH N N O

MM 0776.01 Imp. A (Pharmeuropa): Ethyl 2-Ethoxy-1-[[2'-(1H-tetrazol- O (A) 100 mg 5-yl)-4-biphenylyl]methyl]-1H-benzimidazole-7-carboxylate O N N N NH N N O

MM 0776.07 Imp. H (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]- (A) 100 mg oxy]ethyl 2-Ethoxy-1-[[2'-[1-(triphenylmethyl)-1H- O tetrazol-5-yl]biphenyl-4-yl]methyl]-1H-benz- O O imidazole-7-carboxylate O O (N-Tritylcandesartan Cilexetil) N N N N N N O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 53 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0776.09 Imp. G (EP): 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)- O (A) 100 mg biphenyl-4-yl]methyl]-1H-benzimidazole-7- OH N N carboxylic Acid (Candesartan) N NH N N O

MM 0776.08 Trityl Candesartan O (A) 100 mg OH N N N N N N O

Capecitabine MM 0992.00 Capecitabine O (A) 100 mg HN O F N

O N O

OH OH MM 0992.02 2,3-O-Carbonyl-5-deoxy-5-fluoro- O (A) 100 mg N4-(pentyloxycarbonyl)cytidine HN O F N

O N O

O O

O Captopril

MM 0067.00 Captopril O OH (A) 500 mg O HS N

MM 0067.01 Imp. A (EP): 1,1'-[Disulfanediylbis-[(2S)-2-methyl- O OH (A) 100 mg O 1-oxopropane-3,1-diyl]]- N S bis[(2S)-pyrrolidine-2-carboxylic] Acid S N O (Captopril Disulfide) HO O

O New MM 0067.07 OH (A) 50 mg Imp. B (EP): (2S)-1-[(2S)-3-Bromo-2- O methylpropanoyl]pyrrolidine-2-carboxylic Acid Br N

MM 0067.02 Imp. C (EP): (2RS)-2-Methyl-3-sulfanylpropanoic Acid O (A) 100 mg HS OH

MM 0067.06 Imp. D (EP): (2RS)-3-Bromo-2-methylpropanoic Acid O (A) 100 mg Br OH

MM 0067.08 Imp. E (EP): (2S)-1-[2-Methylpropanoyl]pyrrolidine-2- O OH (A) 100 mg O carboxylic Acid N

MM 0067.05 Imp. J (EP) as Hydrate: (2S)-1-[(2S)-3- O OH (A) 100 mg O O (Acetylsulfanyl)-2-methylpropanoyl]- x H2O S N pyrrolidine-2-carboxylic Acid Hydrate

MM 0067.04 Imp. K (Pharmeuropa): (2S)-3-(Acetylthio)-2- O O (C) 100 mg methylpropanoic Acid S OH

MM 0067.15 Imp. N (EP): 3,3'-Disulfanediylbis[(2S)-2-methylpropanoic] O (A) 50 mg HO S Acid S OH O O O New MM 0067.16 Imp. O (EP): 1,1'-[Propane-2,2-diylbis- HO OH (A) 50 mg O O [sulfanediyl[(2S)-2-methyl-1-oxopropane- 3,1-diyl]]]bis[(2S)-pyrrolidine-2-carboxylic] N S S N Acid

MM 0067.03 Captopril Ethyl Ester O O on request O HS N

54 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Carbamazepine

MM 0076.00 Carbamazepine O (A) 250 mg

N NH2

MM 0076.04 Imp. A (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine- O (A) 100 mg 5-carboxamide (10,11-Dihydrocarbamazepine) N NH2

MM 0076.09 Imp. B (EP): 9-Methylacridine (A) 100 mg

N

MM 0076.12 Imp. C (EP): (5H-Dibenzo[b,f]azepin-5-yl-carbonyl)urea O O (A) 100 mg (N-Carbamoylcarbamazepine) N N NH2 H

MM 0076.08 Imp. D (EP): 5H-Dibenzo[b,f]azepine (Iminostilbene) (B) 100 mg

NH

MM 0076.06 Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (B) 100 mg (Iminodibenzyl) NH

MM 0076.05 Imp. G (EP): 10-Bromo-5H-dibenzo[b,f]azepine- O (A) 100 mg 5-carboxamide (10-Bromocarbamazepine) N NH2

Br

MM 0076.01 Carbamazepine 10,11-Epoxide O (A) 100 mg

N NH2

O

MM 0076.10 10-Hydroxy-10,11-dihydrocarbamazepine O (A) 100 mg

N NH2

HO

MM 0076.17 Oxcarbazepine O (A) 100 mg

N NH2

O Carbasalate Calcium MM 0133.02 Imp. A (EP): 2-(Acetyloxy)benzoic Anhydride O (A) 100 mg (Acetylsalicylic Anhydride) O O O

O

O

O MM 0133.01 Imp. B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid O (A) 100 mg (Acetylsalicylsalicylic Acid) OH O

O O

O

MM 0045.00 Imp. C (EP): Salicylic Acid O (A) 500 mg OH

OH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 55 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0133.03 Imp. D (EP): 2-[(2-Hydroxybenzoyl)oxy]benzoic Acid O (A) 100 mg (Salicylsalicylic Acid) OH

O OH

O

Carbendazim O MM 2500.00 Carbendazim H (A) 100 mg N O NH N MM 2500.01 2,3-Diaminophenazine N NH2 (A) 100 mg

N NH2

MM 2500.02 2-Amino-3-hydroxyphenazine N NH2 (A) 100 mg

N OH Carbenicillin Sodium O MM 0805.00 Carbenicillin Sodium ONa (A) 250 mg O O N

N S H H O ONa Carbocisteine MM 0236.00 Carbocisteine O (A) 500 mg HO S OH O NH2 MM 0236.01 (S)-Carboxymethyl-L-cysteine O (A) 100 mg HO (R/S)-Sulphoxide S OH O O NH2 MM 0236.02 Lactam of (S)-Carboxymethyl-L-cysteine O (A) 100 mg NH S OH O MM 0236.03 L-Cysteinesulfinic Acid O (C) 100 mg HO S OH O NH2 Carisoprodol

MM 0782.03 Imp. C (EP): 2-Methyl-2-propylpropane-1,3-diol HO OH (A) 100 mg

Carvedilol OH MM 0291.00 Carvedilol H (A) 100 mg O N O O

HN

MM 0291.02 Imp. B (EP): 1,1'-[[2-(2-Methoxyphenoxy)- (A) 100 mg ethyl]nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol] OH O NH OH O N O O

HN

MM 0291.03 Imp. C (EP): (2RS)-1-[Benzyl[2-(2-methoxyphenoxy)- (A) 100 mg ethyl]amino]-3-(9H-carbazol-4-yloxy)propan-2-ol OH O N O O

HN

MM 0291.04 Toluene (C) 100 mg

56 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0291.10 4-(2,3-Epoxypropoxy)carbazole O (A) 100 mg O

HN

H2N MM 0291.11 2-(2-Methoxyphenoxy)ethylamine Hydrochloride O (A) 100 mg O x HCl

Cefaclor MM 0326.00 Cefaclor Monohydrate O OH (A) 100 mg O Cl NH 2 N H x H2O N S H O MM 0253.12 Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid NH 2 (B) 100 mg (D-Phenylglycine) OH O MM 0253.08 Imp. F (EP): 3-Phenylpyrazin-2-ol N OH (A) 100 mg

N

Cefadroxil Monohydrate MM 0232.09 Imp. A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid NH2 (B) 100 mg OH

O HO MM 0811.01 Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo- O OH (A) 100 mg 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid O (7-ADCA; 7-Aminodesacetoxycephalosporanic Acid) N

H2N S H Cefalexin Monohydrate MM 0605.00 Cefalexin Monohydrate O OH (A) 500 mg O NH2 H N x H2O N S H O

MM 0253.12 Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid NH 2 (B) 100 mg (D-Phenylglycine) OH O MM 0811.01 Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia- O OH (A) 100 mg 1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid O (7-Aminodesacetoxycephalosporanic Acid; 7-ADCA) N

H 2N S H Cefazolin Sodium MM 0238.00 Cefazolin Sodium O ONa (A) 100 mg O N S H N N S S N N H N O N N MM 0238.05 Imp. E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol (MMTD) SH (A) 100 mg S N N

O OH MM 0238.08 Imp. H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo- O (A) 100 mg 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) O N O

H2N S H Cefetamet MM 0811.01 7-Aminodesacetoxycephalosporanic Acid O OH (A) 100 mg O N

S H 2N H

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 57 Table of content Pharmaceutical impurities

Code Product Price Unit Cefoperazone Sodium MM 0853.03 Imp. C (EP): 1-Methyl-1H-tetrazole-5-thiol SH (A) 100 mg N N N N O OH MM 0238.08 Imp. E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo- O (A) 100 mg 5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) O N O

H2N S H Cefradine MM 0811.01 Imp. A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia- O OH (A) 100 mg 1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid O (7-Aminodeacetoxycephalosporanic Acid, 7-ADCA) N

S H2N H Celecoxib MM 0344.00 Celecoxib (D) 100 mg O O S NH2

N N F F F MM 0344.02 4-[5-[4-(Hydroxymethyl)phenyl]-3-(trifluoromethyl)- HO (D) 100 mg 1H-pyrazol-1-yl]-benzenesulfonamide O O S NH2

N N F F F O MM 0344.03 4-[1-[4-(Aminosulfonyl)phenyl]-3-(trifluoromethyl)- HO (D) 100 mg 1H-pyrazol-5-yl]benzoic Acid O O S NH2

N N F F F Celiprolol Hydrochloride O MM 0128.00 Celiprolol Hydrochloride OH (A) 100 mg H O N O x HCl N N H

O MM 0128.01 Imp. A (EP): 1-[5-Amino-2-[(2RS)- OH (A) 100 mg 3-[(1,1-dimethylethyl)amino]- H O N 2-hydroxypropoxy]phenyl]ethanone

H2N O MM 0128.03 Imp. C (EP): 1-[3-Acetyl-4-[(2RS)- OH (A) 100 mg 3-[(1,1-dimethylethyl)amino]- H O N 2-hydroxypropoxy]phenyl]-3-(1,1-dimethylethyl)urea O N N H H O MM 0128.10 Imp. D (EP):3-[3-Acetyl-4-[(RS)-3-(diethylamino)- OH (D) 100 mg 2-hydroxypropoxy]phenyl]-1,1-diethylurea O N O

N N H

MM 0128.05 Imp. E (EP): 1,1'-[[(1,1-Dimethylethyl)- O O (D) 50 mg OH OH imino]bis[(2-hydroxypropane-1,3-diyl)- O N O oxy(3-acetyl- 1,4-phenylene)]]bis(3,3-diethylurea) HN NH

O N N O

58 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0128.07 Imp. F (EP): 3-(3-Acetyl-4-hydroxyphenyl)- O (A) 100 mg 1,1-diethylurea OH O

N N H

MM 0128.06 Imp. G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]methoxy] O (A) 100 mg O phenyl]-1,1-diethylurea O O

N N H

O MM 0128.04 Imp. H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo- OH (A) 100 mg 2-hydroxypropoxy]phenyl]-1,1-diethylurea O Br (Bromhydrin Compound) O N N H

MM 0128.11 3-Acetyl-4-hydroxyaniline Hydrochloride O (A) 100 mg OH x HCl

H2N MM 0128.58 5-Acetamido-2-hydroxyacetophenone O (A) 100 mg OH O

N H Cethexonium Bromide

MM 0501.01 rac-trans-2-Dimethylaminocyclohexanol Hydrochloride N (A) 100 mg OH x HCl

and enantiomer Cetirizine Dihydrochloride MM 0380.00 Cetirizine Dihydrochloride O (A) 100 mg Cl O N OH N x 2 HCl

MM 0380.01 Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl] (A) 100 mg piperazine

N NH Cl Cl OH MM 0380.02 Imp. B (EP) as Dihydrochloride: (RS)- N (A) 100 mg 2-[4-[(4-Chlorophenyl)phenylmethyl]- N O piperazin-1-yl]acetic Acid Dihydrochloride x 2 HCl

MM 0380.03 Imp. C (EP) as Dihydrochloride: (RS)-2-[2-[4-[(2-Chloro- O (A) 100 mg O phenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid N OH Dihydrochloride N Cl x 2 HCl

MM 0380.04 Imp. D (EP): 1,4-Bis[(4-chlorophenyl)- (A) 100 mg phenylmethyl]piperazine

Cl N N Cl

Cl O OH MM 0380.05 Imp. E (EP) as Dihydrochloride: (RS)- N O (D) 100 mg 2-[2-[2-[4-[(4-Chlorophenyl)phenyl- N O methyl]piperazin-1-yl]ethoxy]ethoxy]- acetic Acid Dihydrochloride x 2 HCl (Ethoxycetirizine Dihydrochloride)

MM 0380.06 Imp. F (EP) as Dihydrochloride: O (A) 100 mg O [2-[4-[Diphenylmethyl]piperazin-1-yl]ethoxy] N OH acetic Acid Dihydrochloride N x 2 HCl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 59 Table of content Pharmaceutical impurities

Code Product Price Unit Cl OH MM 0380.11 Imp. G (EP) as Dihydrochloride: 2-[4-[(RS)- N (A) 100 mg (4-Chlorophenyl)phenylmethyl]piperazin-1-yl] N ethanol Dihydrochloride x 2 HCl

MM 0380.08 Isopropyl Ester of Cetirizine O (A) 100 mg Cl O N O N

MM 0380.09 4-Chlorobenzhydrol (B) 100 mg

OH

Cl MM 0380.10 4-Chlorobenzophenone (B) 100 mg

O

Cl O MM 0380.13 Cetirizine N-Oxide O (A) 100 mg Cl O N OH N

MM 0380.15 Ethyl Ester of Cetirizine Dihydrochloride O (A) 100 mg Cl O N O N x 2 HCl

MM 0380.16 Methyl Ester of Cetirizine Dihydrochloride O (A) 100 mg Cl O N O N

x 2 HCl

MM 0380.17 3-Chlorocetirizine Dihydrochloride ((RS)- O (A) 100 mg O 2-[2-[4-[(3-Chlorophenyl)phenylmethyl]piperazin- N OH 1-yl]ethoxy]acetic Acid Dihydrochloride) N Cl x 2 HCl

Chlorambucil MM 0821.00 Chlorambucil OH (A) 500 mg Cl O N

Cl

Chloramphenicol

OH NO2 MM 0516.00 Chloramphenicol O (A) 500 mg Cl N H Cl OH MM 0516.01 (D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3-propanediol OH NO2 (A) 100 mg

H2N OH Chlordiazepoxide Hydrochloride New MM 0028.08 Chlordiazepoxide [Controlled Substance] H (A) 100 mg N N

Cl N O

60 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0028.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro- H O (A) 100 mg N 2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam) Cl N O

N MM 0028.04 Imp. B (EP): 6-Chloro-2-(chloromethyl)-4-phenylquinazoline Cl (A) 100 mg 3-Oxide N Cl O

MM 0028.03 Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl-methanone NH2 (B) 100 mg (Aminochlorobenzophenone) O Cl

Chlorhexidine Diacetate Cl MM 0162.00 Chlorhexidine Diacetate NH NH (A) 500 mg H H H N N N N N N H H H NH NH Cl O x2 OH MM 0162.05 4-Chloroaniline NH2 (B) 100 mg

Cl MM 0162.07 (4-Chlorophenyl)urea H (A) 100 mg N NH2 O Cl MM 0162.08 (4-Chlorophenyl)guanidine Hydrochloride H (C) 50 mg N NH2 x HCl NH Cl Chlorhexidine Dihydrochloride MM 0946.00 Chlorhexidine Dihydrochloride H H H (A) 500 mg N N N NH NH Cl x 2 HCl Cl NH NH

N N N H H H Chlormezanone MM 0017.00 Chlormezanone Cl (A) 250 mg O O S N O MM 0017.02 2-(4-Chlorophenyl)-3-methylperhydro-1,3-thiazin-4-one Cl on request S N O MM 0017.03 4-Chlorobenzaldehyde O (B) 100 mg Cl H Chlorobutanol Hemihydrate

OH MM 0535.00 Chlorobutanol Hemihydrate Cl (A) 500 mg x ½ H2O Cl Cl Chlorocresol MM 0459.00 Chlorocresol OH (A) 500 mg

Cl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 61 Table of content Pharmaceutical impurities

Code Product Price Unit Chlorphenamine Maleate MM 0090.00 Chlorphenamine Maleate Cl (A) 500 mg O

OH x N OH N O MM 0090.03 Imp. A (EP) as Dihydrochloride: 2-(4-Chlorophenyl)- Cl (D) 100 mg 4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile N Dihydrochloride x 2 HCl

N N

MM 0090.04 Imp. B (EP): N-(Pyridin-2-yl)pyridin-2-amine H (A) 100 mg N N (2,2'-Dipyridylamine) N MM 0090.13 Imp. C (EP) as Maleate: (3RS)-3-(4-Chloro-phenyl)-N- Cl (A) 100 mg methyl-3-(pyridin-2-yl)propan-1-amine Maleate O OH x OH N NH O

MM 0090.05 Imp. D (EP) as Maleate: (2RS)-2-(4-Chloro-phenyl)-4- Cl (D) 100 mg O (dimethylamino)-2-(pyridin-2-yl)butanenitrile Maleate N OH x OH N N O

MM 0090.11 Chlorphenamine N-Oxide Dihydrochloride Cl (A) 100 mg

x 2 HCl N N O

Chlorphenoxamine Hydrochloride MM 1291.00 Chlorphenoxamine Hydrochloride (A) 100 mg

x HCl N O

Cl Hydrochloride MM 0420.00 Chlorpromazine Hydrochloride (A) 500 mg

N N x HCl S

Cl MM 0420.01 Imp. A (EP): 3-(2-Chloro-10H-phenothiazin- (A) 100 mg 10-yl)-N,N-dimethylpropan-1-amine S-Oxide (Chlorpromazine Sulfoxide) N N S O

Cl MM 0420.06 Imp. B (EP) as Dihydrochloride: N-[3-(2-Chloro- (A) 100 mg 10H-phenothiazin-10-yl)propyl]-N,N',N'-trimethyl- propane-1,3-diamine Dihydrochloride N N N S x 2 HCl Cl MM 0290.00 Imp. C (EP) as Hydrochloride: 3-(10H-Phenothiazin- (A) 500 mg 10-yl)-N,N-dimethylpropan-1-amine Hydrochloride N N (Promazine Hydrochloride) x HCl S

MM 0420.07 Imp. D (EP) as Hydrochloride: 3-(2-Chloro-10H- (A) 100 mg phenothiazin-10-yl)-N-methylpropan-1-amine Hydrochloride N NH (Desmethylchlorpromazine Hydrochloride) x HCl S

Cl

62 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0420.04 Imp. E (EP): 2-Chloro-10H-phenothiazine (A) 100 mg

NH S

Cl MM 0420.02 Chlorpromazine Sulphoxide N-Oxide Maleate O (B) 10 mg

N N OH O x S OH O O Cl Chlorprothixene Hydrochloride MM 1321.01 Imp. A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)- (A) 100 mg OH propyl]-9H-thioxanthen-9-ol N S

Cl MM 1321.07 Imp. B (EP) as Hydrochloride: N,N-Dimethyl-3- (A) 50 mg (9H-thioxanthen-9-ylidene)propan-1-amine Hydrochloride N x HCl S

MM 1321.05 Imp. E (EP): 2-Chloro-9H-thioxanthen-9-one (A) 100 mg O

S

Cl Chlorquinaldol MM 0390.00 Chlorquinaldol OH (A) 500 mg Cl N

Cl Chlortalidone MM 0297.00 Chlortalidone O (A) 250 mg HN O O HO S H2N

Cl Chlortetracycline Hydrochloride MM 0607.00 Chlortetracycline Hydrochloride OH O OH O O (A) 500 mg OH NH2 H H x HCl OH Cl OH N MM 0636.00 Imp. B (EP) as Hydrochloride: OH O OH O O (A) 250 mg OH Demeclocycline Hydrochloride NH2 H H x HCl OH Cl OH N

MM 0452.00 Tetracycline Hydrochloride OH O OH O O (A) 500 mg OH NH2 H H x HCl OH HO N Cholecalciferol MM 0249.02 Imp. B (EP): Cholesta-5,7-dien- -ol (A) 100 mg (7,8-Didehydrocholesterol; Provitamin D3)

HO Ciclopirox Olamine

MM 0418.00 Ciclopirox Olamine OH (A) 250 mg N O x OH H2N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 63 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0418.03 Imp. C (EP): 6-Cyclohexyl-4-methylpyridin-2(1H)-one (A) 50 mg H N O

Cimetidine Hydrochloride MM 0020.00 N (A) 500 mg

N N HN S N N H H MM 0020.08 Imp. A (EP): 3-Cyano-2-methyl-1-[2- N (A) 100 mg [[(5-methyl-1H-imidazol-4-yl)methyl]- sulphanyl]ethyl]isothiourea N N HN S N S H MM 0020.12 Imp. B (EP): 3-Cyano-2-methyl-1-[2-[[(5-methyl- N (A) 100 mg 1H-imidazol-4-yl)methyl]sulphanyl]ethyl]isourea N N HN S N O H MM 0020.03 Imp. C (EP) as Dihydrochloride: O NH2 (A) 100 mg 1-[(Methylamino)[[2-[[(5-methyl-1H-imidazol-4-yl)- N N x 2 HCl methyl]sulphanyl]ethyl]amino]methylene]urea HN S Dihydrochloride N N H H (Cimetidine Amide Dihydrochloride)

MM 0020.06 Imp. D (EP) as Dihydrochloride:1-Methyl- N NH (A) 100 mg HN S x 2 HCl 3-[2-[[(5-methyl-1H-imidazol- N N 4-yl)methyl]sulphanyl]ethyl]guanidine Dihydrochloride H H MM 0020.04 Imp. E (EP): 2-Cyano-1-methyl-3-[2-[[(5-methyl- N (A) 100 mg 1H-imidazol-4-yl)methyl]sulphinyl]ethyl]guanidine (Cimetidine Sulphoxide) N O N HN S N N H H MM 0020.15 Imp. G (EP): 2-Cyano-1,3-dimethylguanidine N (A) 100 mg

N

N N H H MM 0020.07 Imp. H (EP): 1,1'-(Disulphanediyldiethylene)bis N (A) 100 mg (2-cyano-3-methylguanidine) N H H S N N N N S H H N

N MM 0020.50 Imp. J (EP) as Dihydrobromide: 2-[[(5-Methyl-1H- N (A) 100 mg HN imidazol-4-yl)methyl]sulphanyl]ethanamine S x 2 HBr NH2 Dihydrobromide 1,1-Dimethyl-3-cyanoguanidine MM 0020.10 H (A) 100 mg N N N NH MM 0056.01 Cyanoguanidine H (B) 100 mg H2 N N N NH Cinchocaine Hydrochloride

MM 0604.00 Cinchocaine Hydrochloride O (A) 500 mg O N N H N x HCl

MM 0604.02 Imp. B (EP): 2-Hydroxyquinoline-4-carboxylic Acid O (A) 100 mg HO OH N

New MM 0604.03 Imp. C (EP): N-[2-(Diethylamino)ethyl]-2- O (A) 50 mg hydroxyquinoline-4-carboxamide HO N N H N

64 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0604.05 Cinchocaine N-Oxide O (A) 100 mg O N N H O N

Cinnarizine

MM 1038.01 Imp. A (EP): 1-(Diphenylmethyl)piperazine NH (A) 100 mg N

MM 1038.03 Imp. B (EP): (Z)-1-(Diphenylmethyl)-4- (A) 100 mg (3-phenylprop-2-enyl)piperazine

N N

MM 1038.04 Imp. C (EP): (4-(Diphenylmethyl)-1,1-bis[(E)- (A) 100 mg N+ 3-phenylprop-2-enyl]piperazinium Chloride N Cl-

MM 1038.06 Imp. E (EP): 1,4-Bis(diphenylmethyl)piperazine (A) 100 mg

N N

Ciprofloxacin Hydrochloride MM 0018.06 Ciprofloxacin Hydrochloride Monohydrate (A) 500 mg HN N N x HCl x H2O OH F O O MM 0018.01 Imp. A (EP): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo- (A) 100 mg 1,4-dihydroquinoline-3-carboxylic Acid Cl N (Fluoroquinolonic Acid) OH F O O MM 0018.05 Imp. B (EP): 1-Cyclopropyl-4-oxo-7-(piperazin-1-yl)- (A) 100 mg HN 1,4-dihydroquinoline-3-carboxylic Acid N N (Desfluoro Compound) OH O O MM 0018.04 Imp. C (EP): 7-(2-Aminoethylamino)-1-cyclopropyl-6- (D) 50 mg fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid H N N (Ethylenediamine Compound) H2 N OH F O O MM 0018.02 Imp. D (EP): 7-Chloro-1-cyclopropyl-4-oxo-6- (D) 50 mg (piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid Cl N

OH N HN O O MM 0018.03 Imp. E (EP): 1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)- (A) 100 mg HN quinolin-4(1H)-one (Decarboxylated Compound) N N

F O MM 0018.10 6-(2-Aminoethylamino)-7-chloro-1-cyclopropyl-4-oxo- (D) 100 mg 1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride Cl N x HCl H2N OH N H O O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 65 Table of content Pharmaceutical impurities

Code Product Price Unit Citalopram Hydrobromide MM 0242.00 Citalopram Hydrobromide F (A) 250 mg x HBr

N O

N MM 0242.14 Imp. A (EP): (1RS)-1-[3-(Dimethylamino)- F (A) 100 mg propyl]-1-(4-fluorophenyl)-1,3-dihydro- isobenzofuran-5-carboxamide (Citalopram- Amide) N O H2N

O MM 0242.17 Imp. C (EP): (3RS)-6-Cyano-3-[3-(dimethyl- F (A) 100 mg amino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one

N O

N O MM 0242.09 Imp. D (EP) as Hydrochloride: (1RS)-1-(4-Fluorophenyl)- F (A) 100 mg 1-[3-(methylamino)propyl]-1,3-dihydroisobenzofuran- 5-carbonitrile Hydrochloride x HCl (Desmethylcitalopram Hydrochloride) N O H

N MM 0242.12 Imp. E (EP) as Oxalate: 3-[(1RS)-5-Chloro- F (A) 50 mg 1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]- N,N-dimethylpropan-1-amine Oxalate HO O x N HO O O Cl MM 0242.13 Imp. F (EP) as Hydrogen Oxalate: 3-[(1R)-5-Bromo- F HO O (A) 100 mg 1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]- x N,N-dimethylpropan-1-amine Hydrogen Oxalate HO O

N O Br Citric Acid Anhydrous

MM 0988.00 Citric Acid Anhydrous O OH (A) 250 mg O HO O HO OH Citric Acid Monohydrate

MM 0575.00 Citric Acid Monohydrate O OH (A) 500 mg O HO O x H 2O HO OH Clarithromycin MM 0057.05 Imp. E (EP): 6,11-Di-O-methylerythromycin A O (D) 100 mg

OH O O OO O N OH OO O OH O

Clindamycin Hydrochloride

MM 0259.00 Clindamycin Hydrochloride N Cl (A) 100 mg H N x HCl O HO O OH S OH

66 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Clioquinol MM 0312.00 Clioquinol OH (A) 500 mg I N

Cl MM 0312.01 Imp. A (EP): 5-Chloroquinolin-8-ol OH (B) 100 mg N

Cl MM 0312.02 Imp. B (EP): 5,7-Dichloroquinolin-8-ol OH (B) 100 mg Cl N

Cl MM 0312.03 Imp. C (EP): 5,7-Diiodoquinolin-8-ol OH (B) 100 mg I N

I Clobenzorex Hydrochloride MM 0649.00 Clobenzorex Hydrochloride (A) 500 mg H N x HCl Cl MM 0769.00 Clobetasol Propionate Cl (A) 100 mg O O

HO O

F O Cl MM 0200.01 Imp. G (EP): 21-Chloro-9-fluoro- -dihydroxy- - O (A) 100 mg methylpregna-1,4-diene-3,20-dione (Clobetasol) HO OH

F O MM 0202.04 Imp. K (EP):9-Fluoro- -dihydroxy- O (A) 100 mg -methyl-3,20-dioxopregna-1,4-dien- O 21-yl Propanoate O (Betamethasone 21-Propionate) HO OH

F O Clobutinol Hydrochloride MM 0038.00 Clobutinol Hydrochloride on request N x HCl OH Cl MM 0038.01 1-Dimethylamino-2-methylbutan-3-one (A) 100 mg N O Citrate

MM 0650.00 Clomifene Citrate O (A) 250 mg O OH N OH x O Cl OH OH and Z-Isomer O MM 0650.01 Clomifene N-Oxide Hydrochloride (A) 100 mg O N O Cl and Z-Isomer x HCl

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Code Product Price Unit MM 0650.03 Desethylclomifene Hydrochloride (A) 100 mg O N H Cl and Z-Isomer x HCl

Clomipramine Hydrochloride MM 0545.00 Clomipramine Hydrochloride Cl (A) 500 mg

x HCl N N

MM 0545.01 Imp. A (EP) as Dihydrochloride: N-[3-(3- Cl on request Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin- 5-yl)propyl]-N,N',N'-trimethylpropane-1,3- diamine Dihydrochloride N N N

x 2 HCl

MM 0077.00 Imp. B (EP) as Hydrochloride: (A) 500 mg Imipramine Hydrochloride N N x HCl

MM 0545.03 Imp. C (EP) as Hydrochloride: 3-(3-Chloro-5H- Cl (C) 10 mg dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine Hydrochloride x HCl N N

MM 0545.04 Imp. D (EP) as Hydrochloride: 3-(3,7-Dichloro- Cl (A) 10 mg 10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N- dimethylpropan-1-amine Hydrochloride x HCl N N

Cl MM 0076.06 Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (B) 100 mg (Iminodibenzyl) NH

MM 0545.06 Imp. F (EP): 3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepine Cl (A) 100 mg

NH

MM 0545.07 Imp. G (EP): 3-Chloro-5-(prop-2-enyl)-10,11-dihydro-5H- Cl (C) 50 mg dibenzo[b,f]azepine

N

MM 0545.08 Desmethylclomipramine Hydrochloride Cl (A) 100 mg

x HCl N N H

MM 0545.09 Clomipramine N-Oxide Cl on request

N N O

68 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0545.13 3-Chloro-10-[3(dimethylamino)propyl]-9-acridanone Cl (A) 100 mg

N N

O

Clonazepam New MM 0945.00 Clonazepam [Controlled Substance] H O (A) 100 mg N

O 2N N

Cl

MM 0945.01 Imp. A (EP): (2-Amino-5-nitrophenyl)(2- NH2 (A) 100 mg chlorophenyl)methanone O O2 N Cl

MM 0945.02 Imp. B (EP): 3-Amino-4-(2-chlorophenyl)-6- H (A) 50 mg N O nitroquinolin-2(1H)-one

O2 N NH2 Cl

MM 0945.04 Methylclonazepam O (A) 50 mg N

O2 N N

Cl

O MM 0945.05 2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide Br (A) 50 mg NH

O O2 N Cl

Clonidine Hydrochloride MM 0983.00 Clonidine Hydrochloride Cl (A) 100 mg HN x HCl N N H Cl MM 0983.04 Imp. A (EP): 1-Acetylimidazolidin-2-one HN (A) 100 mg O N

O Cl MM 0983.03 Imp. B (EP): 1-Acetyl-2-[(2,6-dichloro- N (A) 50 mg phenyl)amino]-4,5-dihydro-1H-imidazole N N H Cl O MM 0006.21 Imp. C (EP): 2,6-Dichloroaniline Cl (B) 100 mg NH2

Cl Cl MM 0983.02 1-(2,6-Dichlorophenyl)thiourea S (A) 100 mg

N NH2 H Cl Clopidogrel Hydrogen Sulphate MM 0455.10 Clopidogrel Hydrogen Sulphate (A) 100 mg

Cl x H2SO4 O N O S MM 0455.09 Clopidogrel Alcohol (D) 100 mg

Cl OH N S

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 69 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0455.13 Imp. B (EP) as Racemate Hydrogen Sulfate: (A) 100 mg Methyl (2RS)-(2-Chlorophenyl)[4,7-dihydro- Cl thieno[2,3-c]pyridin-6(5H)-yl]acetate Hydrogen x H2SO4 S O N O MM 0455.12 Imp. C (EP) as Hydrogen Sulfate: Methyl (A) 100 mg (2R)-(2-Chlorophenyl)[6,7-dihydrothieno[3,2-c]- Cl pyridin-5(4H)-yl]acetate Hydrogen Sulfate x H2SO4 O N O S Clotrimazole MM 0015.00 Clotrimazole Cl (A) 500 mg

N N MM 0015.01 Imp. A (EP): (2-Chlorophenyl)diphenylmethanol (A) 100 mg

Cl OH

MM 0015.10 Imp. B (EP): 1-[(4-Chlorophenyl)diphenylmethyl]- Cl (A) 100 mg 1H-imidazole

N

N MM 0015.03 Imp. C (EP): 1-Chloro-2-(chlorodiphenylmethyl)benzene (A) 100 mg

Cl Cl MM 0015.02 Imp. D (EP): Imidazole H (B) 100 mg N

N MM 0015.06 Imp. E (EP): (2-Chlorophenyl)phenylmethanone (A) 100 mg (2-Chlorobenzophenone)

Cl O MM 0015.11 Imp. F (EP): 1-(Triphenylmethyl)-1H-imidazole (A) 100 mg (Deschloroclotrimazole)

N

N MM 0015.04 (2-Chlorophenyl)diphenylmethane (A) 100 mg

Cl

MM 0015.05 (2-Chlorophenyl)diphenylmethyl Ethyl Ether (A) 100 mg

Cl O

MM 0015.07 (2-Chlorophenyl)phenyldichloromethane (A) 100 mg

Cl Cl Cl MM 0015.08 (2-Chlorophenyl)trichlormethane (A) 100 mg Cl Cl Cl Cl MM 0015.09 1-[(2-Chlorophenyl)diphenylmethyl]-1H-pyrazole (C) 50 mg

Cl N N

Cloxacillin Sodium

MM 0682.00 Cloxacillin Sodium Monohydrate Cl O (A) 500 mg ONa O N N H x H2O O N S H O

70 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit O MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7- OH (B) 100 mg oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid O (6-Aminopenicillanic Acid) N S H2N H MM 0682.04 Imp. D (EP): 3-(2-Chlorophenyl)-5-methylisoxazole-4- Cl (A) 100 mg carboxylic Acid N O OH O Cloxiquine MM 0391.00 Cloxiquine OH (A) 500 mg N

Cl Clozapine

MM 0480.00 Clozapine Cl N (A) 100 mg N N

HN

Cl MM 0480.01 Imp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4] H (A) 100 mg diazepin-11-one N O

HN

MM 0480.03 Imp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H- Cl NH (A) 100 mg dibenzo[b,e][1,4]diazepine N N

HN

Cocaine Hydrochloride

New MM 1345.00 Cocaine Hydrochloride N O (A) 100 mg [Controlled Substance] O x HCl

O

O New MM 1345.04 Benzoylecgonine N O (A) 100 mg [Controlled Substance] OH

O

O Codeine MM 0442.00 Codeine Phosphate Hemihydrate (A) 100 mg N [Controlled Substance] x H3 PO 4 x ½ H2 O

O O OH MM 0004.00 Codeine Monohydrate (A) 100 mg N [Controlled Substance] x H2 O

O O OH MM 0004.03 Imp. A (EP): 7,8-Didehydro- -epoxy- -dimethoxy- (A) 100 mg N 17-methylmorphinan (O-Methylcodeine) [Controlled Substance]

O O O MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: Morphine (A) 250 mg N Hydrochloride Trihydrate [Controlled Substance] x HCl x 3 H2O

HO O OH MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate: (A) 250 mg Morphine Hemisulphate Pentahemihydrate N [Controlled Substance] x H 2SO 4x 5 H2O

HO O OH 2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 71 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0037.02 Imp. C (EP): 7,7',8,8'-Tetradehydro- -diepoxy- (A) 100 mg N 3,3'-dimethoxy-17,17'-dimethyl-2,2'-bimorphinanyl- - HO O O diol (Codeine Dimer; Dimethyl Pseudomorphine)

O O OH N

MM 0004.01 Codeine N-Oxide [Controlled Substance] O (A) 250 mg N

O O OH MM 0004.02 Codeinone (A) 100 mg N

O O O MM 0004.04 Codeimethine (C) 50 mg N

O O OH MM 0004.05 Norcodeine [Controlled Substance] HN (A) 100 mg

O O OH MM 0004.06 Acetylcodeine [Controlled Substance] (A) 100 mg N

O O O O

MM 0004.08 Isocodeine [Controlled Substance] (A) 100 mg N

O O OH MM 0037.01 Pseudomorphine (A) 100 mg N HO O OH

HO O OH N

Colchicine MM 1083.00 Colchicine O (A) 100 mg NH O O O O O MM 1083.04 Imp. D (EP): N-[(7S,12aRa)-3- -D-Glucopyranosyl- HO (A) 100 mg oxy)-1,2,10-trimethoxy-9-oxo-5,6,7,9-tetrahydro- O O benzo[a]heptalen-7-yl]acetamide (Colchicoside) OH NH HO O OH O O O O New MM 1083.06 Imp. F (EP): N-[(7S,12aRa)-10-Hydroxy-1,2,3- O (A) 50 mg trimethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a] NH heptalen-7-yl]acetamide O O (Colchiceine) O O OH MM 0214.00 Cortisone O (A) 500 mg OH O OH

O

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Code Product Price Unit

O MM 0186.00 Cortisone Acetate O (A) 500 mg O O OH

O O MM 0187.00 Imp. A (EP): Acetate O (A) 500 mg O HO OH

O Cyclizine Hydrochloride

MM 1265.01 Imp. A (EP): 1-Methylpiperazine N (A) 100 mg HN MM 0490.02 Imp. B (EP): Diphenylmethanol (Benzhydrol) (B) 100 mg OH

Cyclobenzaprine Hydrochloride MM 0062.02 Cyclobenzaprine Hydrochloride (A) 100 mg

N x HCl

Cyclopentolate Hydrochloride

MM 0580.00 Cyclopentolate Hydrochloride O (A) 500 mg N O x HCl HO

MM 0580.01 Imp. A (EP): (2RS)-(1-Hydroxycyclopentyl)(phenyl) O (A) 100 mg acetic Acid OH HO

MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] O (B) 100 mg

OH MM 0580.03 Imp. C (EP) as Hydrochloride: 2-(Dimethylamino)ethyl O (A) 100 mg x HCl Phenylacetate Hydrochloride N O Cynarine MM 0048.01 3,4-Dihydroxycinnamic Acid (Caffeic Acid) O (B) 100 mg HO OH HO Hydrochloride MM 0609.00 Cyproheptadine Hydrochloride Sesquihydrate (A) 500 mg N

x HCl x 11 /2 H2O

MM 0609.01 Imp. A (EP): 5H-Dibenzo[a,d][7]annulene (A) 50 mg (Dibenzocycloheptene)

MM 0062.01 Imp. B (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]- (B) 100 mg annulen-5-one (Dibenzosuberone) O

MM 0609.07 Imp. C (EP) as Hydrochloride: 5-(1-Methyl- N (A) 50 mg piperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5- OH ol Hydrochloride x HCl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 73 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0609.02 5H-Dibenzo[a,d]cyclohepten-5-one (C) 100 mg (Dibenzosuberenone) O

MM 0609.04 Demethylcyproheptadine Hydrochloride NH (A) 100 mg

x HCl

MM 0609.05 Cyproheptadine α-N-Oxide O (A) 100 mg N

MM 0609.06 Cyproheptadine β-N-Oxide O (A) 100 mg N

Cyproterone Acetate MM 0215.00 Acetate O (A) 250 mg O O

O Cl Dacarbazine MM 1289.00 Dacarbazine N (A) 50 mg HN NH2

N N O N

MM 1289.02 Imp. B (EP): 5-Amino-1H-imidazole-4-carboxamide N (A) 100 mg HN NH2

H2N O MM 0056.06 Imp. D (EP) as Hydrochloride: H (C) 100 mg N x HCl N-Methylmethanamine Hydrochloride DDT MM 2513.01 2,2-Bis(4-chlorophenyl)-1-chloroethane Cl (A) 100 mg

Cl Cl MM 2513.02 1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene (A) 100 mg Cl

Cl MM 2513.05 1,1-Bis(4-chlorophenyl)ethane (A) 100 mg

Cl Cl Delorazepam New MM 1371.00 Delorazepam [Controlled Substance] H O (A) 100 mg N

Cl N

Cl

Dembrexine Hydrochloride Monohydrate MM 1200.03 Imp. C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde O (A) 100 mg OH

Br Br MM 1200.04 Imp. D (EP): 2-Hydroxybenzaldehyde O (A) 100 mg (Salicylaldehyde) OH

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Code Product Price Unit MM 1200.05 Imp. E (EP): 2,4,6-Tribromophenol Br (A) 100 mg OH

Br Br Demeclocycline Hydrochloride MM 0636.00 Demeclocycline Hydrochloride OH O OH O O (A) 250 mg OH NH2 H H x HCl OH Cl OH N Desipramine Hydrochloride MM 0589.00 Desipramine Hydrochloride (A) 250 mg

x HCl N N H

MM 0077.00 Imipramine Hydrochloride (A) 500 mg

x HCl N N

MM 0076.06 Iminodibenzyl (B) 100 mg

NH

Dexamethasone MM 0213.00 Dexamethasone O (A) 250 mg OH HO OH

F O MM 0200.00 Imp. B (EP): Betamethasone O (A) 250 mg OH HO OH

F O MM 0213.01 Imp. C (EP): 9- -Fluoro- - O (D) 50 mg trihydroxy- -methylpregn-4-ene-3,20-dione OH HO OH

F O O MM 0445.00 Imp. G (EP): Dexamethasone Acetate O (A) 250 mg O HO OH

F O Dexamethasone Acetate O MM 0445.00 Dexamethasone Acetate O (A) 250 mg O HO OH

F O MM 0213.00 Imp. A (EP): 9-Fluoro- -trihydroxy- O (A) 250 mg -methylpregna-1,4-diene-3,20-dione OH HO OH (Dexamethasone)

F O O MM 0201.00 Imp. D (EP): 9-Fluoro- -dihydroxy- - O (A) 250 mg methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate O (Betamethasone Acetate) HO OH

F O

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Code Product Price Unit Dexamethasone Sodium Phosphate

MM 0210.00 Dexamethasone Sodium Phosphate O O (A) 250 mg ONa O P HO OH ONa

F O MM 0213.00 Imp. A (EP): 9-Fluoro- -trihydroxy- O (A) 250 mg -methylpregna-1,4-diene-3,20-dione HO OH OH (Dexamethasone)

F O MM 0303.00 Imp. B (EP) as Sodium Salt: 9-Fluoro- - O O (A) 250 mg ONa O P dihydroxy- -methyl-3,20-dioxopregna-1,4- HO OH ONa dien-21-yl Dihydrogen Phosphate Disodium Salt (Betamethasone Sodium Phosphate) F O Dexchlorpheniramine Maleate MM 1114.00 Dexchlorpheniramine Maleate Cl (A) 100 mg O

OH x OH N N O

MM 0059.00 Imp. A (EP) as Maleate: (3RS)-N,N-Dimethyl-3- O (A) 100 mg phenyl-3-(pyridin-2-yl)propan-1-amine Maleate OH (Pheniramine Maleate) x N OH N O Dexpanthenol New MM 1352.04 D,L-Pantolactone O (A) 100 mg HO O

MM 1352.05 Calcium (D,L)-Pantoate (Calcium (RS)-2,4-Dihydroxy- O (A) 50 mg HO 3,3-dimethylbutyrate) - Ca2+ O OH 2 Dextroamphetamine Sulfate

New MM 1359.00 Dextroamphetamine Sulfate [Controlled Substance] N O (A) 100 mg O x HCl

O

O Dextromethorphan Hydrobromide MM 0033.00 Dextromethorphan Hydrobromide Monohydrate (A) 500 mg N x HBr x H2 O

O MM 0033.10 Imp. A (EP) as Hydrochloride: HN (A) 100 mg ent-3-Methoxymorphinan Hydrochloride x HCl

O MM 0033.09 Imp. B (EP) as (L)-Tartrate: (A) 100 mg N ent-17-Methylmorphinan-3-ol (L)-Tartrate OH O x HO OH O OH HO MM 0033.02 Imp. C (EP): ent-3-Methoxy-17-methylmorphinan-10-one (D) 100 mg O N

O

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Code Product Price Unit MM 0033.11 Dextromethorphan N-Oxide Hydrochloride O (A) 100 mg N

x HCl

O Dextropropoxyphene Hydrochloride

MM 0098.01 Dextropropoxyphene Hydrochloride N (A) 50 mg [Controlled Substance] O x HCl O

MM 0098.00 Dextropropoxyphene N (A) 50 mg [Controlled Substance] O

O

MM 0098.06 Imp. A (EP): (2S,3R)-4-(Dimethylamino)-1,2-diphenyl- N (A) 100 mg 3-methylbutan-2-ol

OH

MM 0098.07 Imp. B (EP) as Hydrochloride: (1S,2R)-1-Benzyl- N (A) 100 mg 3-(dimethylamino)-2-methyl-1-phenylpropyl Acetate Hydrochloride O x HCl (Acetoxyphene Hydrochloride) O

MM 0098.08 Imp. C: (EP) as Hydrochloride: (1S,2R)-1-Benzyl- N (A) 50 mg 3-(dimethylamino)-2-methyl-1-phenyl-propyl Butanoate Hydrochloride O x HCl (Butyroxyphene Hydrochloride) O

MM 0291.04 Toluene (C) 100 mg

MM 0098.11 Imp. F (EP) as Hydrochloride: (2RS)-3-(Dimethyl- (A) 50 mg amino)-2-methyl-1-phenylpropan-1-one Hydro- N x HCl chloride O Diazepam

MM 0023.00 Diazepam O (A) 100 mg [Controlled Substance] N Cl N

MM 0023.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H- H O (A) 100 mg N 1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] Cl N

O MM 0023.04 Imp. B (EP): 2-Chloro-N-(4-chloro-2-benzoylphenyl)-N- Cl (A) 100 mg methylacetamide N

O Cl

MM 0023.03 Imp. C (EP): 3-Amino-6-chloro-1-methyl-4-phenylquinolin- (A) 100 mg N O 2(1H)-one

Cl NH2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 77 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0023.01 Imp. D (EP): [5-Chloro-2-(methylamino)phenyl]phenylmethanone (B) 100 mg NH (5-Chloro-2-(methylamino)benzophenone) O Cl

O MM 0023.05 2'-Benzoyl-2,4'-dichloroacetanilide Cl (A) 100 mg NH

O Cl

Dibutyl Sebacate MM 0925.00 Dibutyl Sebacate O O (A) 500 mg

O O Dichlorobenzyl Alcohol

MM 0739.01 Bis-(2,4-dichlorobenzyl)Ether O (A) 100 mg Cl Cl Cl Cl Diclofenac Sodium MM 0006.00 Diclofenac Sodium O ONa (A) 500 mg

NH Cl Cl

MM 0006.01 Imp. A (EP): 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one (A) 100 mg O N Cl Cl

MM 0006.03 Imp. B (EP): 2-[(2,6-Dichlorophenyl)amino]benzaldehyde O (A) 100 mg NH Cl Cl

MM 0006.04 Imp. C (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]methanol OH (A) 100 mg NH Cl Cl

MM 0006.09 Imp. D (EP): 2-[2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic Acid OH (D) 100 mg O NH Br Cl

MM 0006.05 Imp. D (EP) as Sodium Salt: Sodium 2-[2-[(2-Bromo- ONa (D) 100 mg 6-chlorophenyl)amino]phenyl]acetate O NH Br Cl

MM 0006.02 Imp. E (EP): 1,3-Dihydro-2H-indol-2-one (B) 100 mg O N H MM 0006.06 1-(2-Bromo-6-chlorophenyl)indolin-2-one (C) 10 mg O N Br Cl

MM 0006.10 Methyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate O (A) 100 mg (Methyl Ester of Diclofenac) O NH Cl Cl

MM 0006.11 Ethyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate O (A) 100 mg (Ethyl Ester of Diclofenac) O NH Cl Cl

78 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0181.06 Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate O (A) 100 mg (Isopropyl Ester of Diclofenac) O NH Cl Cl

MM 0006.12 2-(2,6-Dichlorophenylamino)benzoic Acid O (A) 100 mg OH NH Cl Cl

MM 0006.15 2,6-Dichlorodiphenylamine (A) 100 mg

NH Cl Cl

MM 0006.16 2-Bromo-6-chlorodiphenylamine (A) 100 mg

NH Br Cl

MM 0006.17 1-(2,6-Dichlorophenyl)indolin-2,3-dione O (A) 100 mg O N Cl Cl

MM 0006.18 Diclofenac Potassium OK (A) 100 mg O NH Cl Cl

MM 0006.19 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide Cl (A) 100 mg

N O Cl Cl

MM 0006.20 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid OH (A) 100 mg (Diclofenac) O NH Cl Cl

MM 0006.21 2,6-Dichloroaniline NH2 (B) 100 mg Cl Cl

MM 0006.22 2-Bromo-6-chloroaniline NH2 on request Br Cl

MM 0006.27 N-Acetyl-N-phenyl-2,6-dichloroaniline O (A) 100 mg N Cl Cl

MM 0006.28 Diethyl O (C) 100 mg O O

O Dicloxacillin Sodium

MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7- O (B) 100 mg OH oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O N (6-Aminopenicillanic Acid) H2 N S H Valerate MM 0600.00 Diflucortolone Valerate O (A) 100 mg O O HO

F O F

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Code Product Price Unit

MM 0336.01 Digitoxigenin O O (A) 50 mg

OH HO Digoxin

MM 0212.00 Digoxin O O (A) 250 mg OH

OH OO H

OO OH OO OH HO OH Dihydrocodeine Hydrogen Tartrate

MM 0812.07 Dihydrocodeine Hydrochloride N (A) 100 mg [Controlled Substance] x HCl

O O OH New MM 0812.00 Dihydrocodeine Hydrogen Tartrate N (A) 100 mg [Controlled Substance] OH O x HO OH O OH O O OH MM 0004.00 Imp. A (EP) as Monohydrate: N (A) 100 mg Codeine Monohydrate [Controlled Substance] x H2O

O O OH MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: N (A) 100 mg Codeine Phosphate Hemihydrate x H3PO4 [Controlled Substance] x 1/2 H2O

O O OH MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate: (A) 250 mg N Morphine Hemisulphate Pentahemihydrate [Controlled Substance] x H2SO4 x 5 H2O

HO O OH 2 MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: N (A) 250 mg Morphine Hydrochloride Trihydrate x HCl [Controlled Substance] x 3 H2O

HO O OH Diltiazem Hydrochloride MM 0068.00 Diltiazem Hydrochloride O (A) 500 mg

S O N O O x HCl N

MM 0068.02 Imp. B (EP): (2S,3S)-2-(4-Methoxyphenyl)-4-oxo- O (A) 100 mg 2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate S O N O H O

80 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0068.03 Imp. D (EP) as Hydrochloride: (2S,3S)-2-(4-Methoxyphenyl)- O (A) 100 mg 5-[2-(methylamino)ethyl]-4-oxo-2,3,4,5-tetrahydro- 1,5-benzothiazepin-3-yl Acetate Hydrochloride S (N-Desmethyldiltiazem Hydrochloride) O x HCl N O O

HN

MM 0068.04 Imp. E (EP):(2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)- O (A) 100 mg 2,3-dihydro-1,5-benzothiazepin-4(5H)-one S OH N H O MM 0068.05 Imp. F (EP):(2S,3S)-5-[2-(Dimethylamino)ethyl]-3- O (A) 100 mg hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5- benzothiazepin-4(5H)-one S OH N O

N

MM 0068.07 Diltiazem Sulphoxide O (A) 100 mg O S O N O O

N

MM 0068.08 Diltiazem Maleate O (A) 100 mg

O S O OH x OH N O O O N Dimenhydrinate

MM 0599.00 Dimenhydrinate O (A) 500 mg H O N N N x Cl O N N

MM 0176.00 Imp. A (EP): Theophylline O (A) 500 mg H N N

O N N

MM 0599.04 Dimenhydrinate Imp. B (Pharmeuropa): O (A) 100 mg H 8-[(2-(Diphenylmethoxy)-ethyl)(methlyl)amino]- N N 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione N O N N O

MM 0494.00 Imp. C (EP): Caffeine O (A) 500 mg N N

O N N

MM 0599.08 Imp. E (EP): 8-Chloro-1,3,7-trimethyl-3,7- O (A) 50 mg N dihydro-1H-purine-2,6-dione N (8-Chlorocaffeine) Cl O N N

MM 0490.03 Imp. F (EP) as Hydrochloride: (A) 100 mg 2-(Diphenylmethoxy)-N-methylethanamine Hydrochloride (Diphenhydramine Imp. A H x HCl N Hydrochloride; Nordiphenhydramine Hydrochloride) O

MM 0490.04 Imp. G (EP) as Hydrochloride: (A) 100 mg N,N-Dimethyl-2-[(4-methylphenyl)- (phenyl)methoxy]ethanamine Hydrochloride x HCl (4-Methyldiphenhydramine Hydrochloride) N O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 81 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0640.00 Imp. H (EP) as Hydrochloride: 2-[(RS)-(4- (A) 100 mg Bromophenyl)(phenyl)methoxy]-N,N-dimethyl- ethanamine Hydrochloride (4-Bromodiphen- x HCl N hydramine Hydrochloride; Bromazine Hydro- O chloride) Br MM 0490.02 Imp. I (EP): Diphenylmethanol (B) 100 mg (Benzhydrol)

OH

MM 0630.01 Imp. J (EP): Diphenylmethanone (B) 100 mg (Benzophenone)

O

MM 0599.14 Imp. K (EP): [Oxybis(methanetriyl)]tetrabenzene (A) 50 mg (Bis(diphenylmethyl) Ether)

O

MM 0490.00 Diphenhydramine Hydrochloride (A) 500 mg

x HCl N O

O MM 0155.02 8-Chlorotheophylline H (B) 100 mg N N Cl O N N

MM 0599.03 8-[N-(2-Diphenylmethoxyethyl)-N,N- O (A) 100 mg N- dimethylaminium]-1,3-dimethylxanthine N inner salt N+ O N N O

Dimetindene Maleate MM 0595.01 Imp. A (EP): 2-Ethylpyridine N (B) 100 mg

MM 0595.02 Imp. B (EP) as Hydrochloride: 2-(1H-Inden- (A) 50 mg 2-yl)-N,N-dimethylethanamine Hydrochloride x HCl N

New MM 0595.04 Imp. D (EP) as Hydrochloride: (2RS)-2-Benzyl- (A) 50 mg 4-(dimethylamino)butanoic Acid Hydrochloride x HCl HO N O MM 0595.10 Imp. E (EP) as Hydrochloride: (2RS)-2-[2-(Dimethyl- (A) 50 mg amino)ethyl]indan-1-one Hydrochloride x HCl N O MM 0595.06 Imp. F (EP) as Hydrochloride: 2-(3-Butyl-1H- (A) 50 mg inden-2-yl)-N,N-dimethylethanamine Hydro- x HCl chloride N

MM 0595.07 Imp. G (EP) as Hydrochloride: N,N-Dimethyl- (A) 50 mg 2-(3-phenyl-1H-inden-2-yl)ethanamine Hydro- x HCl chloride N

New MM 0595.11 Imp. I (EP) as Maleate: N-Methyl-2-[3-[(1RS)- O (A) 50 mg 1-( yridine-2-yl)ethyl]-1H-inden-2-yl]ethanamine N OH Maleate x H N OH O

82 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Diphemanil Metilsulfate MM 1163.00 Diphemanil Metilsulfate (D) 100 mg N+

O O x -O S O

Diphenhydramine Hydrochloride MM 0490.00 Diphenhydramine Hydrochloride (A) 500 mg

x HCl N O

MM 0490.03 Imp. A (EP) as Hydrochloride: 2-(Diphenylmethoxy)-N- (A) 100 mg methylethanamine Hydrochloride (Nordiphenhydramine Hydrochloride) H x HCl N O

MM 0490.04 Imp. B (EP) as Hydrochloride: 2-[(RS)- (A) 100 mg (4-Methylphenyl)phenylmethoxy]-N,N- dimethylethanamine Hydrochloride x HCl N (4-Methyldiphenhydramine Hydrochloride) O

MM 0640.00 Imp. C (EP) as Hydrochloride: 2-[(RS)- (A) 100 mg (4-Bromophenyl)phenylmethoxy]-N,N- dimethylethanamine Hydrochloride x HCl N (Bromazine Hydrochloride) O

Br MM 0490.02 Imp. D (EP): Diphenylmethanol (Benzhydrol) (B) 100 mg

OH

MM 0630.01 Imp. E (EP): Diphenylmethanone (Benzophenone) (B) 100 mg

O

MM 0490.01 Diphenhydramine N-Oxide (A) 100 mg

O N O

Diphenylpyraline Hydrochloride MM 0557.00 Diphenylpyraline Hydrochloride (A) 500 mg O x HCl N

MM 0155.01 Diphenylpyraline (A) 100 mg O N

MM 0490.02 Diphenylmethanol (Benzhydrol) (B) 100 mg OH

MM 0630.01 Diphenylmethanone (Benzophenone) (B) 100 mg O

MM 0557.04 Diphenylpyraline N-Oxide (A) 100 mg O

N O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 83 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0468.04 N-Desmethyldiphenylpyraline Hydrochloride (A) 100 mg (4-(Diphenylmethoxy)piperidine Hydrochloride) NH x HCl O

Dipipanone Hydrochloride MM 0760.01 1,1-Diphenylbut-1-ene (A) 100 mg

MM 0760.02 1-(1-Methyl-3,3-diphenylpropyl)piperidine Hydrochloride (A) 100 mg

x HCl N

Dipotassium Clorazepate MM 0028.03 Imp. A (EP): (2-Amino-5-chlorophenyl)phenylmethanone NH 2 (B) 100 mg (Aminochlorobenzophenone) O Cl

MM 0023.02 Imp. B (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H- H O (A) 100 mg N 1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] Cl N

Diprafenon Hydrochloride MM 0428.01 2'-Hydroxy-3-phenylpropiophenone O (A) 100 mg

OH Diprenorphine

New MM 1384.00 Diprenorphine N (D) 50 mg

OH HO O O Diprophylline MM 0176.01 Imp. A (EP): N-Methyl-5-(methylamino)-1H- O (A) 100 mg H imidazole-4-carboxamide (Theophyllidine) N N H HN N

MM 0176.00 Imp. B (EP): 1,3-Dimethyl-3,7-dihydro-1H- O (A) 500 mg H purine-2,6-dione (Theophylline) N N

O N N

MM 0603.00 Imp. C (EP): 7-(2-Hydroxyethyl)-1,3-dimethyl- O (A) 500 mg OH N 3,7-dihydro-1H-purine-2,6-dione (Etofylline) N

O N N

Dipyridamole

MM 0462.03 Imp. C (EP): 2,2'-[[6-Chloro-4,8-di(piperidin-1- OH (A) 100 mg yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N N N N OH N Cl N N

84 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Disopyramide MM 0108.00 Disopyramide (A) 500 mg N N

NH2

O

New MM 0108.03 Imp. B (EP) as Dihydrogen Phosphate: (3RS)- (A) 50 mg N,N-Bis(1-methylethyl)-3-phenyl-3-(pyridin-2- N yl)propan-1-amine Dihydrogen Phosphate x H3PO4 N

Dithranol MM 0137.00 Dithranol OH O OH (A) 500 mg

MM 0137.04 Imp. A (EP): Anthracen-9(10H)-one (Anthrone) O (A) 100 mg

MM 0137.01 Imp. B (EP): 1,8-Dihydroxyanthracene-9,10-dione OH O OH (A) 100 mg (Danthron)

O MM 0137.02 Imp. C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-bianthracenyl- OH O OH (A) 100 mg 10,10'(9H,9'H)-dione (Dithranol Dimer)

OH O OH Dobutamine Hydrochloride MM 0384.00 Imp. A (EP) as Hydrochloride: Dopamine Hydrochloride HO NH2 (A) 500 mg x HCl HO MM 0675.02 Imp. B (EP): 4-(4-Hydroxyphenyl)butan-2-one OH (C) 100 mg O

Dodecylguanidinium Acetate MM 0451.03 Dodecylnitrile N (B) 100 mg

MM 0451.05 Dimethyldodecylamine (B) 100 mg N

MM 0107.00 Domperidone O O (D) 100 mg HN N N N NH

Cl MM 0107.06 Imp. A (EP): 5-Chloro-1-(piperidin-4-yl)- O (A) 100 mg 1,3-dihydro-2H-benzimidazol-2-one HN N NH

Cl

O MM 0107.05 Imp. B (EP): 4-(5-Chloro-2-oxo-2,3-dihydro- O (A) 100 mg 1H-benzimidazol-1-yl)-1-formylpiperidine N NH N

Cl

MM 0107.03 Imp. F (EP): 1,3-Bis[3-[4-(5-chloro-2-oxo- O O O (A) 50 mg 2,3-dihydro-1H-benzimidazol-1-yl)piperidin- HN N N NH N N N N 1-yl]propyl]-1,3-dihydro-2H-benzimidazol- 2-one Cl Cl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 85 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0107.07 1,3-Dihydro-2H-benzimidazol-2-one H (B) 100 mg N O N H Donepezil Hydrochloride MM 0677.00 Donepezil Hydrochloride (D) 100 mg N O x HCl O

O MM 0677.01 Donepezil (D) 100 mg N O O

O MM 0677.02 2,3-Dihydro-5,6-dimethoxy-2-[(4-piperidinyl)- NH (A) 100 mg methyl]indan-1-one Hydrochloride O O x HCl

O MM 0677.16 1-Benzyl-4-[(5,6-dimethoxy-1H-inden- (A) 50 mg 2-yl)methyl]piperidine N

O

O New MM 0677.14 Donepezil N-Oxide (A) 50 mg O N O O

O New MM 0677.08 5,6-Dimethoxy-2-[(4-pyridyl)methyl]indan-1-one N (A) 100 mg O O

O New MM 0677.09 1,1-Dibenzyl-4-[(5,6-dimethoxy-1oxo-2,3-dihydro- (A) 50 mg 1H-inden-2-yl)methyl]piperidinium Bromide Br-

N+ O O

O Dopamine Hydrochloride

MM 0384.00 Dopamine Hydrochloride HO NH2 (A) 500 mg x HCl HO MM 0384.02 Imp. A (EP) as Hydrochloride: 5-(2-Aminoethyl)- HO NH2 (A) 100 mg 2-methoxyphenol Hydrochloride x HCl O (4-O-Methyldopamine Hydrochloride) MM 0384.04 Imp. C (EP): 2-(3,4-Dimethoxyphenyl)ethanamine O NH2 (A) 100 mg

O MM 0384.01 (R,S)-α-Methyldopamine Hydrobromide HO NH2 (A) 100 mg x HBr HO Dorzolamide Hydrochloride MM 0403.00 Dorzolamide Hydrochloride O O (A) 50 mg S O S O S x HCl H2N HN Dosulepin Hydrochloride

MM 0510.00 Dosulepin Hydrochloride N (A) 100 mg

x HCl S

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Code Product Price Unit MM 0510.02 Imp. B (EP): Dibenzo[b,e]thiepin-11(6H)-one (A) 100 mg O

S

MM 0510.08 Nordosulepin Hydrochloride N (A) 50 mg H x HCl S

Doxazosin Mesilate MM 0386.00 Doxazosin Mesilate O (A) 100 mg O N O N N O N O O O x S NH2 OH MM 0386.08 Doxazosin O (A) 100 mg O N O N N O N O NH2 MM 0386.04 Imp. A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-2- O (A) 100 mg carboxylic Acid HO O O

MM 0386.05 Imp. B (EP) as Hydrochloride: 1-[(2RS)-2,3-Dihydro- O (A) 100 mg 1,4-benzodioxin-2-ylcarbonyl]piperazine Hydrochloride N O x HCl HN O

MM 0386.06 Imp. C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin- O (A) 100 mg 2-ylcarbonyl)piperazine O N O O N O

O MM 0085.07 Imp. D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione H (C) 100 mg O N O

NH O O MM 0085.06 Imp. E (EP): 2,4-Dichloro-6,7-dimethoxyquinazoline O N Cl (A) 100 mg N O Cl MM 0386.01 Imp. F (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine O N Cl (A) 100 mg N O NH2 MM 0386.12 Imp. F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- O N Cl (A) 100 mg O O quinazolin-4-amine Mesilate x N S O OH NH2

MM 0085.01 Imp. G (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin- NH (A) 100 mg 4-amine O N N

N O NH2 MM 0085.03 Imp. H (EP): 2,2'-(Piperazine- NH2 (D) 100 mg O 1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) N

N N O O N N

N O NH2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 87 Table of content Pharmaceutical impurities

Code Product Price Unit Doxepin Hydrochloride

MM 0032.00 Doxepin Hydrochloride N (A) 500 mg

x HCl O

MM 0032.03 Imp. A (EP): Dibenzo[b,e]oxepin-11(6H)-one (A) 100 mg (Doxepinone) O

O

MM 0032.04 Imp. B (EP): (11RS)-11-[3-(Dimethylamino)- (A) 50 mg N propyl]-6,11-dihydrodibenzo[b,e]oxepin- OH 11-ol (Doxepinol)

O

MM 0032.08 Imp. C (EP) as E/Z-Mixture: (E,Z)-3-(Dibenzo[b,e]- (A) 50 mg NH oxepin-11(6H)-ylidene)-N-methylpropan-1-amine ((E,Z)-Desmethyldoxepin)

O

Doxycycline Hyclate New MM 0276.00 Doxycycline Hyclate OH O OH O O (A) 100 mg OH NH2 H H OH OH N x HCl x 1/2 C2H5OH x 1/2 H2O Doxylamine Hydrogen Succinate MM 0101.00 Doxylamine Hydrogen Succinate O (A) 500 mg OH N N x O OH O MM 0101.02 Imp. B (EP) as Hydrochloride: (1RS)-1-Phenyl- (A) 50 mg 1-(pyridin-2-yl)ethanol Hydrochloride x HCl N OH

MM 0101.03 Imp. C (EP) as Hydrogen Fumarate: N,N- O (A) 50 mg Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)- OH methoxy]ethanamine Hydrogen Fumarate x N N HO O O MM 0101.04 Imp. D (EP): Phenyl(pyridin-2-yl)methanone (A) 100 mg (2-Benzoylpyridine)

N O

MM 0101.05 Doxylamine N-Oxide Dihydrochloride (A) 100 mg

O x 2 HCl N N O

MM 0101.08 N-Desmethyldoxylamine Hydrogen Succinate O (A) 50 mg OH H x N N OH O O Drofenine Hydrochloride MM 0768.00 Drofenine Hydrochloride (A) 500 mg

x HCl O N O

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Code Product Price Unit MM 0768.01 Drofenine N-Oxide Hydrochloride (A) 100 mg

x HCl O N O O Droperidol

MM 0138.01 Imp. A (EP): 1-(1,2,3,6-Tetrahydropyridin- HN (A) 50 mg 4-yl)-1,3-dihydro-2H-benzimidazol-2-one N NH O New MM 0138.03 Imp. C (EP): 1-[4-(4-Fluorophenyl)-4-oxo- F (A) 50 mg Cl- butyl]-4-(2-oxo-2,3-dihydro-1H-benzimidazol- 1-yl)pyridinium Chloride N+ O N NH O MM 0138.04 Imp. D (EP) as Hydrochloride: (1RS)- F (A) 100 mg 1-[4-(4-Fluorophenyl)-4-oxobutyl]- O N 4-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)- x HCl 1,2,3,6-tetrahydro-pyridine 1-Oxide O N Hydrochloride NH O Dropropizine

MM 1017.00 Dropropizine N OH (A) 500 mg N OH

Duloxetine Hydrochloride MM 1122.00 Duloxetine Hydrochloride (A) 100 mg S x HCl

O N H MM 0043.04 Imp. D (EP): Naphthalen-1-ol (1-Naphthol) (B) 100 mg

OH Dydrogesterone New MM 0328.02 Imp. B (EP): Pregna-4,6-diene-3,20-dione O (A) 100 mg -)

O Ebastine MM 0468.00 Ebastine (A) 100 mg

N O O

MM 0490.02 Imp. A (EP): Diphenylmethanol (Benzhydrol) (B) 100 mg

OH

MM 0468.03 Imp. B (EP): 1-[4-(1,1-Dimethylethyl)phenyl]ethanone (A) 100 mg

O MM 0468.04 Imp. C (EP) as Hydrochloride: 4-(Diphenyl- (A) 100 mg methoxy)piperidine Hydrochloride NH x HCl O

MM 0468.05 Imp. D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]- (A) 100 mg 4-(4-hydroxypiperidin-1-yl)butan-1-one N O HO

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 89 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0468.06 Imp. E (EP) as Hydrogen Fumarate: (A) 100 mg 1-[4-(1,1-Dimethylpropyl)phenyl]- 4-[4-(diphenylmethoxy)piperidin- N 1-yl]butan-1-one Hydrogen Fumarate O O x O HO OH O Econazole Nitrate MM 0524.00 Econazole Nitrate Cl (A) 500 mg

Cl x HNO3 O N Cl N MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2- Cl (A) 100 mg (1H-imidazol-1-yl)ethanol

Cl

HO N

N MM 0524.02 Imp. B (EP) as Nitrate: (2RS)-2-[(4-Chlorobenzyl)oxy]- Cl (D) 100 mg 2-(2,4-dichlorophenyl)ethanamine Nitrate

Cl x HNO3 O NH2 Cl MM 0524.03 Imp. C (EP) as Chloride: 1-(4-Chlorobenzyl)- Cl (A) 100 mg 3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4- dichlorophenyl)ethyl]imidazolium Chloride Cl

O Cl- N+ Cl N Cl

Emedastine Difumarate MM 1277.02 Imp. B (EP): 2-Chloro-1-(2-ethoxyethyl)-1H- O (A) 100 mg Benzimidazole N Cl N

Enalapril Maleate O MM 0010.00 Enalapril Maleate O OH O (A) 100 mg H N N OH x OH O O O

MM 0010.05 Imp. B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- O (A) 100 mg H 3-phenylpropyl]amino]propanoic Acid N OH

O O

O MM 0010.01 Imp. C (EP): (2S)-1-[(2S)-2-[[(1S)-1-Carboxy- O OH (D) 100 mg 3-phenylpropyl]amino]propanoyl]pyrrolidine-2- H N carboxylic Acid (Enalaprilat) N HO O MM 0010.06 Imp. D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-1,4-dioxo- H (A) 100 mg O octahydropyrrolo[1,2-]pyrazin-2-yl]-4-phenylbutanoate N (Enalapril diketopiperazine) N O

O O

MM 0015.02 Imp. I (EP): 1H-Imidazole (Imidazole) H (B) 100 mg N N

90 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0010.15 (2S)-2[[(1S)-1-(Ethoxycarbonyl)- O (A) 100 mg H 3-phenylpropyl]amino]propanoic Acid Ethyl Ester N O Hydrochloride x HCl O O

Enilconazole MM 0281.01 Imp. E (EP): (1RS)-1-(2,4-Dichlorophenyl)-2- Cl (A) 100 mg (1H-imidazol-1-yl)ethanol

Cl

HO N

N Enrofloxacin MM 0395.00 Enrofloxacin (A) 100 mg N N N OH F O O MM 0018.01 Imp. A (EP): 7-Chloro-1-cyclo- (A) 100 mg propyl-6-fluoro-4-oxo-1,4-dihydroquinoline- Cl N 3-carboxylic Acid OH F O O MM 0018.06 Imp. B (EP) as Hydrochloride Monohydrate: (A) 500 mg HN Ciprofloxacin Hydrochloride Monohydrate N N x HCl x H 2O OH F O O MM 0395.01 Imp. C (EP) as Hydrochloride: (A) 100 mg N 1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-4- N N oxo-1,4-dihydroquinoline-3-carboxylic Acid x HCl Hydrochloride (Desfluoroenrofloxacin OH Hydrochloride) O O MM 0018.04 Imp. G (EP): 7-[(2-Aminoethyl)amino]-1- (D) 50 mg H2N cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline- HN N 3-carboxylic Acid OH F O O MM 0395.07 Enrofloxacin N-Oxide Hydrochloride O (A) 100 mg N N N x HCl OH F O O Entacapone N MM 1221.02 Imp. A (EP): (2Z)-2-Cyano-3-(3,4-dihydroxy- HO (A) 50 mg 5-nitrophenyl)-N,N-diethylprop-2-enamide HO O N NO2 MM 1221.04 Imp. B (EP): Ethyl (2E)-2-Cyano-3-(3,4- O (A) 50 mg O 2N dihydroxy-5-nitrophenyl)prop-2-enoate O

HO N OH MM 1221.01 O2 N (A) 100 mg Imp. C (EP): 3,4-Dihydroxy-5-nitrobenzaldehyde O HO OH MM 1221.05 Imp. D (EP): (2E)-2-Cyano-3-(3-ethoxy-4- O (A) 50 mg O 2N hydroxy-5-nitrophenyl)-N,N-diethylprop-2- N enamide HO N O

MM 1221.06 Imp. E (EP): 3,5-Dinitrobenzene-1,2-diol O2 N NO2 (A) 50 mg

HO OH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 91 Table of content Pharmaceutical impurities

Code Product Price Unit MM 1221.07 Imp. F (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- O (A) 50 mg O 2N 5-nitrophenyl)prop-2-enoic Acid OH

HO N OH MM 1221.03 Imp. H (EP): (2E)-3-(3,4-Dihydroxy-5-nitro- O (A) 50 mg O 2N phenyl)-2-(piperidin-1-ylcarbonyl)prop-2- N ennitrile HO N OH MM 1221.09 Imp. I (EP): Propyl (2E)-2-Cyano-3-(3,4- O (A) 50 mg O 2N dihydroxy-5-nitrophenyl)prop-2-enoate O

HO N OH Ephedrine Hydrochloride

OH MM 0652.00 Ephedrine Hydrochloride H (A) 500 mg N [Drug Precursor] x HCl

Imp. B (EP) as Hydrochloride: OH MM 2115.00 H (A) 500 mg Pseudoephedrine Hydrochloride N x HCl [Drug Precursor]

OH MM 0652.03 (1S,2R)-(+)-Ephedrine Hydrochloride H (A) 100 mg N [Drug Precursor] x HCl

New MM 0652.04 Methylephedrine (1R,2S)-Methylephedrine) OH (A) 100 mg N

Ephedrine Sulphate

MM 1147.00 Ephedrine Sulphate OH (A) 250 mg [Drug Precursor] H N x H2SO4

2 Erdosteine

MM 0544.00 Erdosteine S O (A) 100 mg O O S N OH H

MM 0544.01 2-Chloro-N-(2-oxotetrahydrothiophen-3-yl)acetamide S O (A) 100 mg O Cl N H Ergometrine Maleate

New MM 1385.00 Ergometrine Maleate H O (A) 100 mg N [Drug Precursor] OH HN H x N OH OH O O Erythromycin MM 0132.13 Imp. B (EP): N-Demethylerythromycin A O (D) 100 mg

OH HO HO OO O NH OH OO O OH O

MM 0132.10 Imp. E (EP): Erythromycin A Enol Ether (A) 50 mg

O OH HO OO O N OH OO O OH O

92 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Esomeprazole Trihydrate MM 0095.03 Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol (A) 100 mg O NH

N SH MM 0095.04 Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin- (A) 100 mg O 2-yl)methyl]sulphinyl]-5-methoxy-1H-benzimidazole NH N S O N MM 0095.06 Imp. C (EP): 5-Methoxy-2-[[(4-methoxy- (A) 100 mg O 3,5-dimethylpyridin-2-yl)methyl]- NH O sulphanyl]-1H-benzimidazole (Ufiprazole) N S N MM 0095.05 Imp. D (EP): 5-Methoxy-2-[[(4-methoxy- (A) 100 mg O 3,5-dimethylpyridin-2-yl)methyl]sulphonyl]-1H- NH O benzimidazole (Omeprazole Sulphone) N S O O N MM 0095.07 Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1H- (A) 100 mg O benzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine NH O 1-Oxide (Omeprazole N-Oxide) N S O N O Estazolam New MM 1354.00 Estazolam [Controlled Substance] N (A) 100 mg N N

Cl N

Estradiol Benzoate MM 0301.00 Benzoate OH (A) 500 mg

O O

MM 0300.00 Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate OH (A) 500 mg

x 1/2 H2O

HO MM 0301.02 Imp. C (EP): Estra-1,3,5(10)-triene- -diyl O (A) 100 mg Dibenzoate (Estradiol 3,17-Dibenzoate) O

O O

MM 0301.07 Imp. D (EP): 3-Hydroxyestra-1,3,5(10)-trien- - O (A) 100 mg yl Benzoate (Estradiol 17-Benzoate) O

HO MM 0301.03 Imp. E -Hydroxyestra-1,3,5(10)-trien-3-yl OH (C) 10 mg Benzoate (17-epi-) O O

MM 0301.08 Imp. G (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl Benzoate O (A) 100 mg ( Benzoate)

O

O

MM 0278.01 Benzoic Acid O (B) 100 mg OH

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Code Product Price Unit Estradiol Enanthate MM 0473.00 Estradiol Enanthate O (A) 100 mg O

HO Estradiol Hemihydrate MM 0300.00 Estradiol Hemihydrate OH (A) 500 mg

x 1/2 H2O

HO MM 0282.00 Imp. A (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one O (A) 500 mg (Estrone)

HO MM 0300.01 Imp. B (EP): Estra-1,3,5(10)-triene- -diol OH (A) 100 mg -Estradiol; 17-epi-Estradiol)

HO MM 0300.06 Imp. C (EP): 4-Methylestra-1,3,5(10)-triene- -diol OH (A) 100 mg (4-)

HO

MM 0300.02 Imp. D (EP): Estra-1,3,5(10),9(11)-tetraene-3,17β-diol OH (D) 100 mg (9,11-Didehydroestradiol)

HO New MM 0300.04 6alpha-Hydroxyestradiol OH (A) 100 mg

HO OH MM 0300.03 -Hydroxyestradiol OH (D) 50 mg

HO OH MM 0300.08 6-Ketoestradiol OH (A) 100 mg

HO O Estradiol Valerate MM 0209.00 Estradiol Valerate O (A) 500 mg O

HO MM 0300.00 Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate OH (A) 500 mg

x 1/2 H2O

HO MM 0209.06 Imp. B -Hydroxyestra-1,3,5(10)-trien-3-yl OH (A) 100 mg Pentanoate (Estradiol 3-Valerate) O

O MM 0209.01 Imp. C (EP): 3-Hydroxyestra-1,3,5(10),9(11)-tetraen- O (D) 100 mg -yl Pentanoate (9,11-Didehydroestradiol Valerate) O

HO

94 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0209.07 Imp. D (EP): 3-Hydroxy-4-methylestra-1,3,5(10)-trien- O (D) 100 mg -yl Pentanoate (4-Methylestradiol Valerate) O

HO

MM 0209.02 Imp. E (EP): Estra-1,3,5(10)-trien- -diyl O (A) 100 mg Dipentanoate (Estradiol 3,17-Divalerate) O

O O MM 0209.04 Imp. F (EP): 3-Hydroxyestra-1,3,5(10)-trien- -yl O (A) 100 mg Butanoate (Estradiol Butyrate) O

HO MM 0209.03 17-epi- -Estradiol Valerate) O (D) 100 mg O

HO Sodium Phosphate MM 0100.01 Estramustine OH (D) 100 mg

O Cl N O Cl MM 0100.02 - - NaO O O ONa (D) 50 mg PP Bis3-{bis(2-chloro- OOO ethyl)carbamoyl- oxy}estra-1,3,5(10)- trienyl O O Pyrophosphate Cl Cl N O O N Disodium Salt Cl Cl

Estriol MM 0130.00 OH (A) 100 mg OH

HO MM 0130.06 Imp. A (EP): Estra-1,3,5(10),9(11)-tetraene- -triol OH (D) 100 mg (9,11-Didehydroestriol) OH

HO MM 0282.00 Imp. B (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one O (A) 500 mg (Estrone)

HO MM 0130.01 Imp. C (EP): 3-Methoxyestra-1,3,5(10)-triene- -diol OH (D) 100 mg (Estriol 3-Methyl Ether) OH

O MM 0300.00 Imp. D (EP) as Hemihydrate: OH (A) 500 mg Estradiol Hemihydrate x 1/2 H2O

HO MM 0130.05 Imp. E (EP): Estra-1,3,5(10)-triene- -triol OH (D) 100 mg (17-epi-Estriol) OH

HO MM 0130.04 Imp. F (EP): Estra-1,3,5(10)-triene- -triol OH (D) 100 mg (16-epi-Estriol) OH

HO

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Code Product Price Unit MM 0130.03 Imp. G (EP): Estra-1,3,5(10)-triene- -triol OH (D) 100 mg (16,17-epi-Estriol) OH

HO MM 0130.22 Imp. I (EP): 3-Hydroxy-17-oxa-D-homoestra-1,3,5(10)- O on request trien-17a-one O

HO MM 0130.02 -Hydroxyestriol OH (D) 100 mg OH

HO OH MM 0130.14 Estriol 16,17-Diacetate O (D) 100 mg O

O O HO MM 0130.15 Estriol Triacetate O (D) 100 mg O

O O O O MM 0130.16 Estriol 3-Benzyl Ether OH (D) 100 mg OH

O MM 0130.17 16-Oxoestradiol OH (D) 100 mg O

HO MM 0130.18 6-Oxoestriol OH (D) 100 mg OH

HO O conjugated MM 0282.00 Imp. I (EP): 3-Hydroxyestra-1,3,5(10)-trien- O (A) 500 mg 17-one (Estrone)

HO Estrone MM 0282.00 Estrone O (A) 500 mg

HO MM 0282.01 Estrone 3-Methyl Ether O (A) 100 mg

O Ethacridine Lactate Monohydrate

NH2 MM 0798.00 Ethacridine Lactate Monohydrate O (A) 250 mg O x x H2O OH OH H2N N MM 0123.00 Ethinylestradiol OH (A) 500 mg

HO MM 0123.02 Imp. B (EP): 19-Nor- -pregna-1,3,5(10),9(11)-tetraen- OH (D) 50 mg 20-yne-3,17-diol (9,11-Didehydroethinylestradiol)

HO

96 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0282.00 Imp. C (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one O (A) 500 mg (Estrone)

HO MM 0300.00 Imp. D (EP) as Hemihydrate: OH (A) 500 mg Estradiol Hemihydrate x 1/2 H2O

HO MM 0123.07 Imp. E (EP): 19-Nor- -pregna- OH (D) 100 mg 1,3,5(10)-trien-20-yne- -triol -Hydroxyethinylestradiol) HO OH MM 0123.06 Imp. F (EP): 19-Nor- -pregna- OH (D) 25 mg 1,3,5(10)-trien-20-yne- -triol -Hydroxyethinylestradiol)

HO OH MM 0123.05 Imp. G (EP): 3,17-Dihydroxy-19- OH (D) 100 mg nor- -pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxoethinylestradiol, 6-Ketoethinylestradiol) HO O MM 0123.08 Imp. I (EP): 19-Nor- -pregna- OH (D) 50 mg 1,3,5(10),6-tetraen-20-yne-3,17-diol (6,7-Didehydroethinylestradiol)

HO MM 0300.01 Imp. L (EP): Estra-1,3,5(10)-triene- OH (A) 100 mg - -Estradiol; 17-epi-Estradiol)

HO Ethionamide MM 0845.00 Ethionamide S (A) 250 mg NH 2 N MM 0845.01 Ethionamide Sulphoxide O (D) 100 mg S

NH 2 N Ethosuximide

MM 0750.00 Ethosuximide H (A) 500 mg O N O

Ethyl Parahydroxybenzoate MM 0498.00 Ethyl Parahydroxybenzoate O (A) 500 mg O HO MM 0498.05 Sodium Ethyl Parahydroxybenzoate O (A) 500 mg O

NaO MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg OH HO MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate O (A) 500 mg (Methyl Parahydroxybenzoate) O HO MM 0432.00 Imp. C (EP): Propyl 4-Hydroxybenzoate O (A) 500 mg (Propyl Parahydroxybenzoate) O HO MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate O (A) 500 mg (Butyl Parahydroxybenzoate) O HO

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 97 Table of content Pharmaceutical impurities

Code Product Price Unit Ethylmorphine Hydrochloride

MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: N (A) 250 mg Morphine Hydrochloride Trihydrate [Controlled Substance] x HCl x 3 H2O

HO O OH MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate: (A) 250 mg N Morphine Hemisulphate Pentahemihydrate [Controlled Substance] x H2SO4 x 5 H2O

HO O OH 2

MM 0004.00 Imp. C (EP) as Monohydrate: Codeine Monohydrate N (A) 100 mg [Controlled Substance] x H2O

O O OH

MM 0442.00 Imp. C (EP) as Phosphate Hemihydrate: N (A) 100 mg Codeine Phosphate Hemihydrate x H3PO4 [Controlled Substance] x 1/2 H2O

O O OH Etilefrine Hydrochloride

OH MM 0035.00 Etilefrine Hydrochloride H (A) 500 mg HO N x HCl

OH MM 0081.00 Imp. B (EP) as Hydrochloride: (1RS)- H (A) 500 mg HO N 1-(3-Hydroxyphenyl)-2-(methylamino)ethanol x HCl Hydrochloride (Phenylephrine Hydrochloride)

MM 0973.00 Imp. C (EP) as Hydrochloride: (1RS)-2-Amino- OH (A) 500 mg HO NH2 1-(3-hydroxyphenyl)ethanol Hydrochloride x HCl (Norfenefrine Hydrochloride)

MM 0035.08 Imp. D (EP) as Hydrochloride: 2-(Benzylethyl-amino)- (A) 100 mg 1-(3-hydroxyphenyl)ethanone Hydrochloride O (Benzyletilefrone Hydrochloride) x HCl HO N

MM 0035.05 Imp. E (EP): 1-(3-Hydroxyphenyl)ethanone O (C) 100 mg (3-Hydroxyacetophenone) HO

MM 0035.06 Imp. F (EP): N-Benzylethanamine (Benzylethylamine) (C) 100 mg

HN

MM 0035.50 3-Benzoyloxyacetophenone O (A) 100 mg O O

MM 0035.51 3-Benzoyloxy--bromoacetophenone O on request O Br O Etizolam New MM 1386.00 Etizolam N (A) 100 mg N N S

N

Cl

Etodolac MM 0911.00 Etodolac O (A) 250 mg H OH N O

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Code Product Price Unit MM 0911.01 Imp. A (EP): 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydro- O (A) 100 mg pyrano[3,4-b]indol-1-yl]acetic Acid H OH (8-Desethyl Etodolac) N O

MM 0911.02 Imp. B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9- O (A) 100 mg tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid H OH (8-Methyl Etodolac) N O

MM 0911.03 Imp. C (EP): 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9- O (A) 100 mg tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid H OH (1-Methyl Etodolac) N O

MM 0911.04 Imp. D (EP): 2-[(1RS)-1-Ethyl-8-(1-methylethyl)- O (A) 50 mg 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic H OH Acid (8-Isopropyl Etodolac) N O

MM 0911.06 Imp. F (EP): 2-[(1RS)-8-Ethyl-1-(1-methylethyl)- O (A) 100 mg 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic H OH Acid (1-Isopropyl Etodolac) N O

MM 0911.07 Imp. G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9- (A) 100 mg O tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid H (1-Propyl Etodolac) OH N O

MM 0911.08 Imp. H (EP): 2-(7-Ethylindol-3-yl)ethanol H (A) 100 mg N OH

MM 0911.10 Imp. J (EP): (1RS)-1,8-Diethyl-1-methyl-1,3,4,9- (A) 100 mg tetrahydropyrano[3,4-b]indole H (Decarboxy Etodolac N O

MM 0911.11 Imp. K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9- O (A) 100 mg tetrahydropyrano[3,4-b]indol-1-yl]acetate H O (Etodolac Methyl Ester) N O

Etofenamate MM 0410.00 Imp. A (EP): 2-[[3-(Trifluoromethyl)phenyl]amino]benzoic Acid O (A) 500 mg (Flufenamic Acid) OH

NH

F F F MM 0105.02 Imp. B (EP): Butyl 2-[[3-(Trifluoromethyl)phenyl]amino]benzoate O (A) 100 mg (Butyl Flufenamate) O

NH

F F F MM 0105.03 Imp. C (EP): N-Phenyl-3-(trifluoromethyl)aniline (A) 100 mg

NH

F F F MM 0105.04 Imp. D (EP): 2,2'-Oxybis(ethylene) O O (A) 100 mg O Bis[2-[[3-(trifluoromethyl)phenyl]amino]benzoate] O O

NH HN

F F F F F F

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Code Product Price Unit MM 0105.05 Imp. E (EP): 2-(2-Butoxyethoxy)ethyl 2-[[3- O (A) 100 mg O (Trifluoromethyl)phenyl]amino]benzoate O O

NH

F F F O MM 0105.06 Imp. F (EP): 2,2'-Oxydiethanol HO OH (A) 100 mg MM 0105.07 Imp. G (EP): 2-Hydroxyethyl O (A) 100 mg OH 2-[[3-(Trifluoromethyl)phenyl]amino]benzoate O

NH

F F F MM 0105.08 Etofenamate Myristate O O (A) 100 mg O O O

NH

F F F

MM 0105.09 Etofenamate Palmitate O O (A) 100 mg O O O

NH

F F F

MM 0105.10 Etofenamate Stearate O O (A) 100 mg O O O

NH

F F F

MM 0105.11 Triethylene Glycol Flufenamate O (A) 100 mg O OH O O

NH

F F F Etofylline MM 0603.00 Etofylline O (A) 500 mg OH N N

O N N

Etomidate MM 1264.00 Etomidate N (A) 100 mg O N O

MM 1264.04 Imp. A (EP) as R-Enantiomer: 1-[(1R)-1- N (A) 50 mg Phenylethyl]-1H-imidazole-5-carboxylic OH N Acid (Etomidate Acid) O

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Code Product Price Unit Famciclovir MM 0620.01 9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino- Cl (A) 100 mg O N 6-chloropurine N O N H2N N O

O Famotidine

NH2 MM 0029.00 Famotidine NH2 (A) 250 mg H2N N S N NH2 N S S O O

NH MM 0029.06 Imp. A (EP) as Hydrochloride: 3-[[[2- NH2 (A) 100 mg H2 N N [(Diaminomethylene)amino]thiazol-4-yl]- S NH2 x HCl N methyl]sulphanyl]propanimidamide S Hydrochloride

MM 0029.05 O O (D) 50 mg Imp. B (EP) as Dimaleate: S N N 3,5-Bis[2-[[[2-[(diaminomethylene)amino]- NH2 H2 N H2N N N NH2 thiazol-4-yl]methyl]sulphanyl]ethyl]-4H- S N S N H N 1,2,4,6-thiatriazine 1,1-Dioxide Dimaleate S S O OH x2 OH

O

O O O MM 0029.01 Imp. C (EP) as Hydrochloride: NH 2 (A) 100 mg S H 2N N NH 2N 3-[[[2-[(Diaminomethylene)amino]thiazol- S 4-yl]methyl]sulphanyl]-N-sulphamoylpropanamide N H S Hydrochloride x HCl

O MM 0029.02 Imp. D (EP): 3-[[[2-[(Diaminomethylene)amino] NH 2 (A) 100 mg thiazol-4-yl]methyl]sulphanyl]propanamide H 2N N S NH 2 N S MM 0029.07 Imp. E (EP): 2,2'-[Disulphanediylbis- NH2 H2 N (A) 100 mg H2 N NH2 (methylenethiazole-4,2-diyl)]diguanidine N S S N N N S S O MM 0029.03 Imp. F (EP): 3-[[[2-[(Diaminomethylene)amino] NH2 (A) 100 mg H2N N thiazol-4-yl]methyl]sulphanyl]propanoic Acid S OH N S O MM 0029.09 Imp. G (EP) as Maleate: N-Cyano- NH (A) 100 mg NH2 N 3-[[[2-(diaminomethylene)amino]thiazol- H2N N OH S N x N OH 4-yl]methyl]sulphanyl]propanimidamide Maleate H S O

NH 2 MM 0029.04 Famotidine Sulphoxide NH 2 (A) 100 mg H 2N N S N NH 2 N S O S O O O O O MM 0029.10 Imp. I (Pharmeuropa): 3-[[[2-[(Diaminomethylene)- NH2 (D) 50 mg S H2N N amino]thiazol-4-yl]methyl]sulfinyl]-N-sulfamoyl- S NH2N N H propanamide O S MM 0029.51 2-[(Diaminomethylene)amino]-4-(4-cyanobutyl) N on request N thiazole Hydrochloride N x HCl H2 N S NH2 Felodipine MM 0139.00 Felodipine H (A) 100 mg N O O

O O Cl

Cl MM 0139.01 Imp. A (EP): Ethyl Methyl 4-(2,3-Dichlorophenyl)- N (D) 50 mg 2,6-dimethylpyridine-3,5-dicarboxylate O O

O O Cl

Cl

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Code Product Price Unit MM 0139.02 Imp. B (EP): Dimethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl- H (A) 100 mg N 1,4-dihydropyridine-3,5-dicarboxylate O O

O O Cl

Cl MM 0139.03 Imp. C (EP): Diethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl- H (A) 100 mg N 1,4-dihydropyridine-3,5-dicarboxylate O O

O O Cl

Cl Fenbendazole O MM 2500.00 Imp. A (EP): Methyl (1H-Benzimidazol-2-yl)carbamate H (A) 100 mg (Carbendazim) N O NH N O MM 0518.01 Fenbendazole Sulphoxide (Oxfendazole) H (A) 100 mg N O NH S N O O MM 0518.02 Fenbendazole Sulphone H (A) 100 mg N O NH S N O O Fenbufen MM 0918.00 Fenbufen O (A) 500 mg OH

O

MM 0918.03 Imp. C (EP): Biphenyl (A) 100 mg

MM 0918.05 4-(4-Chlorophenyl)-4-oxobutanoic Acid O (A) 100 mg (3-(4-Chlorobenzoyl)propionic Acid) OH O Cl Fencamfamine Hydrochloride New MM 0995.01 Camfetamine Hydrochloride (N-Methyl-3- (A) 100 mg phenylnorbornan-2-amine Hydrochloride) x HCl

HN Fenfluramine Hydrochloride MM 0608.00 Fenfluramine Hydrochloride H (A) 500 mg N x HCl F F F MM 0608.01 Norfenfluramine Hydrochloride NH 2 (A) 100 mg

x HCl F F F O MM 0608.02 N-Nitrosofenfluramine N (A) 100 mg N

F F F Fenofibrate MM 0505.00 Fenofibrate O (A) 500 mg Cl O O

O MM 0505.01 Imp. A (EP): (4-Chlorophenyl)(4-hydroxyphenyl)methanone Cl OH (C) 100 mg

O

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Code Product Price Unit MM 0505.03 Imp. C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)- O (A) 100 mg phenoxy]butan-2-one Cl O

O MM 0505.04 Imp. D (EP): Methyl 2-[4-(4-Chlorobenzoyl)- O (A) 100 mg Cl O phenoxy]-2-methylpropanoate O

O MM 0505.05 Imp. E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)- O (A) 100 mg Cl O phenoxy]-2-methylpropanoate O

O MM 0505.06 Imp. F (EP): (4-Chlorophenyl)[4-(1-methyl- Cl O (A) 100 mg ethoxy)phenyl]methanone

O MM 0505.07 Imp. G (EP): 1-Methylethyl O (A) 50 mg Cl O O 2-[[2-[4-(4-Chlorobenzoyl)phenoxy]-2- O methylpropanoyl]oxy]-2-methylpropanoate O

O Fenoprofen Calcium MM 0790.00 Fenoprofen Calcium Dihydrate (A) 500 mg O- O Ca 2+ x 2 H 2O O 2 Fentanyl MM 0528.00 Fentanyl [Controlled Substance] (A) 100 mg

O N

N

MM 0528.09 Imp. A (EP) as Hydrochloride: N-Phenyl-N- (A) 100 mg O [cis,trans-1-oxido-1-(2-phenylethyl)piperidin- 4-yl]propanamide Hydrochloride O N x HCl (Fentanyl N-Oxide Hydrochloride) N

MM 0528.08 Imp. B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide O NH (A) 100 mg

N

MM 0528.03 Imp. C (EP): N-phenyl-N-[1-(2-phenylethyl)- (A) 100 mg piperidin-4-yl]acetamide O N

N

MM 0528.04 Imp. D (EP): N-phenyl-1-(2-phenylethyl)piperidin-4-amine (A) 100 mg

N

HN

MM 0093.17 Imp. F (EP) as Hydrochloride: Aniline Hydrochloride NH2 (B) 100 mg x HCl (Phenylamine Hydrochloride)

MM 0528.07 Imp. G (EP): N-Phenylpropanamide O (A) 100 mg NH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 103 Table of content Pharmaceutical impurities

Code Product Price Unit Fexofenadine Hydrochloride MM 0507.01 Imp. A (EP): 2-[4-[4-[4-(Hydroxydiphenyl- (A) 100 mg methyl)piperidin-1-yl]butanoyl]phenyl]- OH 2-methylpropanoic Acid (Ketofexofenadine) O N O

OH

MM 0507.03 Imp. C (EP): (1RS)-4-[4-(Hydroxydiphenyl- (A) 100 mg methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- OH phenyl]butan-1-ol OH N

MM 0055.02 Imp. E (EP): Diphenyl(piperidin-4-yl)methanol (B) 100 mg OH

NH MM 0415.00 Finasteride O H (A) 100 mg N

O N H MM 0415.01 Imp. A (EP): N-(1,1-Dimethylethyl)-3-oxo- O H (A) 100 mg N 4-aza-5α--17β-carboxamide (Dihydrofinasteride)

O N H H O MM 0415.02 Imp. B (EP): Methyl 3-Oxo-4-aza- -androst- O (A) 100 mg 1-ene- - -1-Aza Ester)

O N H H MM 0415.04 3-Oxo-4-aza-5alpha-androstane-17beta-carboxylic Acid O (A) 100 mg OH

O N H H Flavoxate Hydrochloride MM 0156.00 Flavoxate Hydrochloride O (A) 100 mg

x HCl O N O O MM 0156.01 Imp. A (EP): 3-Methyl-4-oxo-2-phenyl-4H-1- O (A) 100 mg benzopyran-8-carboxylic Acid (3-Methyl-flavone-8-carboxylic Acid) O

O OH MM 0156.02 Imp. B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl- O (A) 100 mg 4H-1-benzopyran-8-carboxylate (3-Methyl- flavone-8-carboxylic Acid Ethyl Ester) O

O O MM 0156.05 Imp. C (EP): 1-Methylethyl-3-Methyl-4-oxo- O (A) 50 mg 2-phenyl-4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic Acid Isopropyl Ester) O

O O

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Code Product Price Unit Flecainide Acetate

MM 0488.02 Imp. B (EP): (RS)-(Piperidin-2-yl)methanamine H2N (A) 100 mg HN MM 0488.04 Imp. D (EP): 2,5-Bis(2,2,2-trifluoroethoxy) F F O (A) 100 mg O benzoic Acid F OH F O F F Fluanisone MM 1247.02 1-(2-Methoxyphenyl)piperazine Dihydrochloride (A) 100 mg x 2 HCl N HN O Flubendazole

MM 0463.00 Flubendazole H O (A) 100 mg F N O NH N O MM 0463.02 Imp. B (EP): (2-Amino-1H-benzimidazol- H (A) 100 mg F N 5-yl)(4-fluorophenyl)methanone NH2 N O MM 0463.03 Imp. C (EP): (4-Fluorophenyl)(2-hydroxy-1H- H (C) 50 mg F N benzimidazol-5-yl)methanone OH N O MM 0463.04 Imp. D (EP): (1H-Benzimidazol-5-yl)(4-fluorophenyl) H on request F N methanone N O MM 0463.05 Imp. E (EP): Methyl [5-(2-Fluorobenzoyl)-1H- H O (C) 50 mg N O benzimidazol-2-yl]carbamate NH N F O MM 0463.06 Imp. F (EP): Methyl [5-(4-Fluorobenzoyl)-1-methyl-1H- O (C) 50 mg F N O benzimidazol-2-yl]carbamate NH N O

MM 0463.07 Imp. G (EP): Methyl [5-[4-(1-Methylethoxy)benzoyl]-1H- H O (D) 100 mg O N O benzimidazol-2-yl]carbamate NH N O Flucloxacillin Sodium

MM 0489.00 Flucloxacillin Sodium Hydrate O (A) 500 mg Cl ONa O N F N x H 2O O H N S H O MM 0489.01 Imp. A (EP) as Disodium Salt: (4S)-2-[Carboxy[[[3-(2-chloro- O (A) 100 mg Cl 6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]- ONa 5,5-dimethylthiazolidine-4-carboxylic Acid Disodium Salt N F HN (Penicilloic Acids of Flucloxacillin Disodium Salt) O H N S O O ONa

MM 0489.02 Imp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)- O (A) 50 mg Cl OH 5-methylisoxazol-4-yl]carbonyl]amino]methyl]-5,5-dimethyl- thiazolidine-4-carboxylic Acid N F HN O NH (Penilloic Acids of Flucloxacillin) S O MM 0026.04 O (B) 100 mg Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia- OH 1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O N (6-Aminopenicillanic Acid) H2 N S H MM 0489.03 Imp. D (EP): 3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole- (C) 100 mg Cl 4-carboxylic Acid N F O OH O

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Code Product Price Unit Fluconazole MM 0235.00 Fluconazole F (A) 100 mg F N HO N N N N N MM 0235.11 Imp. A (EP): (2RS)-2-(2,4-Difluorophenyl)-1- F (A) 100 mg (1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol F N HO N N N

N N

MM 0235.12 Imp. B (EP): 2-[2-Fluoro-4-(1H-1,2,4-triazol-1- N N (D) 100 mg yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol N

F N HO N N N N N

MM 0235.13 Imp. C (EP): 1,1'-(1,3-Phenylene)di-1H-1,2,4-triazole N N (A) 50 mg N N N N MM 0235.14 Imp. D (EP): 2-(4-Fluorophenyl)-1,3-bis(1H- F (A) 100 mg 1,2,4-triazol-1-yl)propan-2-ol N HO N N N N N MM 0235.02 Imp. F (EP): (2RS)-2-(2,4-Difluorophenyl)-3- F (A) 50 mg (1H-1,2,4-triazol-1-yl)propane-1,2-diol F N HO N N OH MM 0235.07 Imp. H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)- F (A) 50 mg 3-(1H-1,2,4-triazol-1-yl)propan-2-ol F N HO N N Br MM 0235.01 2-(2,4-Difluorophenyl)propane-1,2,3-triol F (A) 100 mg F HO HO

OH MM 0235.03 1H-1,2,4-Triazol H (B) 100 mg N N N MM 0235.04 2-Chloro-2',4'-difluoroacetophenone F (C) 100 mg

F

O Cl MM 0235.06 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanol F (A) 100 mg F

HO N N N MM 0235.09 4-Amino-1,2,4-triazole N (C) 100 mg N N H2N

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Code Product Price Unit Flucytosine MM 0593.00 Imp. A (EP): 5-Fluoropyrimidine-2,4(1H,3H)-dione O (A) 500 mg F (Fluorouracil) HN

O N H Flufenamic Acid MM 0410.00 Flufenamic Acid O (A) 500 mg OH

NH

F F F Pivalate MM 0427.01 Imp. A -Difluoro- -trihydroxy- - O (A) 100 mg methylpregna-1,4-diene-3,20-dione (Flumetasone) OH HO OH

F O F Flunarizine Dihydrochloride F MM 0175.00 Flunarizine Dihydrochloride N (A) 500 mg N

x 2 HCl

F F MM 0175.04 Imp. A (EP): 1-[Bis(4-fluorophenyl)methyl]piperazine NH (A) 100 mg N

F F MM 0175.03 Imp. C (EP) as Dihydrochloride: N (A) 100 mg 1-[(RS)-(2-Fluorophenyl)(4-fluoro- N phenyl)methyl]-4-[(2E)-3-phenylprop- x 2 HCl 2-enyl]piperazine Dihydrochloride F

MM 0175.02 Chlorobis-(4-fluorophenyl)methane Cl (B) 100 mg

F F MM 0175.05 1-Bis(4-fluorophenyl)methyl-4-(ethoxycarbonyl)piperazine O O (B) 10 mg N

N

F F O MM 0175.06 Flunarizine N-Oxide Dihydrochloride F (A) 100 mg N N

x 2 HCl

F Flunitrazepam

MM 0069.00 Flunitrazepam [Controlled Substance] O (A) 100mg N

O2N N F

MM 0069.02 Imp. B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H- H O (A) 100 mg N 1,4-benzodiazepin-2-one (Demethylflunitrazepam) O2N N F

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 107 Table of content Pharmaceutical impurities

Code Product Price Unit Flunixin Meglumine MM 0915.00 Flunixin Meglumine F F (A) 100 mg F H N OH x HO N NH OH OH OH HO O MM 0915.01 Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid N Cl (A) 100 mg OH

O MM 0915.03 Imp. C (EP): Ethyl 2-Chloropyridine-3-carboxylate N Cl (A) 100 mg O

O Fluorescein Sodium MM 0294.01 Imp. A (EP): Resorcinol (B) 100 mg

HO OH MM 0133.04 Imp. C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic Acid (A) 100 mg OH

O O

HO OH Fluorouracil MM 0593.00 Fluorouracil O (A) 500 mg F HN O N H MM 0265.03 Imp. A (EP): Pyrimidine-2,4,6-(1H,3H,5H)- O (C) 100 mg trione (Barbituric Acid) HN

O N O H MM 0593.01 Imp. B (EP): Dihydropyrimidine-2,4,5(3H)- O (A) 100 mg O trione (Isobarbituric Acid or 5-Hydroxyuracil) HN

O N H MM 0593.03 Imp. C (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil) O (C) 100 mg HN

O N H MM 0593.05 Imp. E (EP): 5-Chloropyrimidine-2,4(1H,3H)dione O (A) 100 mg Cl (5-Chlorouracil) HN

O N H MM 0593.06 Imp. F (EP): 2-Ethoxy-5-fluoropyrimidin- O (A) 100 mg F 4(1H)-one (2-Ethoxy-5-fluorouracil) N

O N H Fluoxetine Hydrochloride MM 0256.00 Fluoxetine Hydrochloride H (A) 50 mg O N F x HCl F F

MM 0256.01 Imp. A (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol H (A) 100 mg HO N

MM 0256.02 Imp. B (EP) as Hydrochloride: N-Methyl-3- H (A) 100 mg N phenylpropan-1-amine Hydrochloride (Methyl-3-phenylpropylamine Hydrochloride) x HCl [Controlled Substance]

MM 0256.03 Imp. C (EP) as Hydrochloride:(3RS)-N-Methyl-3- H (A) 100 mg O N phenyl-3-[3-(trifluoromethyl]phenoxy]propan-1-amine Hydrochloride x HCl F F F

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Code Product Price Unit MM 0256.05 4-Hydroxybenzotrifluoride OH (B) 100 mg F F F MM 0256.06 4-Chlorobenzotrifluoride Cl (B) 100 mg F F F MM 0256.10 3-Dimethylamino-1-phenylpropan-1-ol OH (A) 100 mg N

MM 0256.16 N-Formylfluoxetine O (A) 100 mg O N

F F F

F MM 256.17 (3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)- F (A) 100 mg F phenoxy]propan-1-amine Hydrochloride H (2-Trifluoromethylisomer of Fluoxetine Hydro-chloride) O N

x HCl

New MM 0256.18 Norfluoxetine Oxalate O NH2 (A) 100 mg HO O F x F F HO O MM 0959.00 Fluoxymesterone OH (A) 100 mg HO

F O Flupentixol Decanoate MM 0182.08 Imp. B (BP): 2-Trifluoromethylthioxanthone O (A) 100 mg CF3

S

HN MM 0182.05 1-(2-Hydroxyethyl)piperazine OH (B) 100 mg N MM 0182.06 cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene on request CF3

S MM 0182.07 4-Chloro-3-nitrobenzotrifluoride O2N CF3 (B) 100 mg

Cl

MM 0182.09 4-Fluoro-3-nitrobenzotrifluoride O2 N CF3 (B) 100 mg

F Flupentixol Dihydrochloride MM 0182.08 Imp. G (EP): 2-(Trifluoromethyl)-9H-thioxanthen-9-one O (A) 100 mg (2-Trifluoromethylthioxanthone) CF3 S

HN MM 0182.05 1-(2-Hydroxyethyl)piperazine OH (B) 100 mg N MM 0182.06 cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene on request CF3

S MM 0182.07 4-Chloro-3-nitrobenzotrifluoride O 2N CF3 (B) 100 mg

Cl OH MM 0223.06 Flupentixol Dihydrochloride N (A) 100 mg N

S x 2 HCl

F F F

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 109 Table of content Pharmaceutical impurities

Code Product Price Unit Fluphenazine Dihydrochloride MM 0114.00 Fluphenazine Dihydrochloride (A) 500 mg

N N S N x 2 HCl OH F F F MM 0114.01 Imp. A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)- (A) 100 mg 4- 10H- -10-yl]propyl]piperazin-1- N N S N yl]ethanol (Fluphenazine S-Oxide) O OH F F F MM 0114.07 Imp. D (EP): 10,10'-[Piperazine-1,4-diylbis(propane- F F (A) 100 mg 3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine] F

S N N N N S

F F F MM0826.00 Imp. E (EP): 2-[4-[3-[2-Chloro-10H-phenothiazin- (A) 100 mg 10-yl]propyl]piperazin-1-yl]ethanol (Perphenazine) N N S N OH

Cl MM 0114.04 Fluphenazine N,N',S-Trioxide Dihydrochloride (A) 100 mg O N N S N x 2 HCl O OH O F F F Flurazepam Monohydrochloride MM 0070.01 Imp. A (EP): [5-Chloro-2-[[2-(diethylamino)ethyl]amino] H on request N phenyl]-(2-fluorophenyl)methanone N O Cl F

MM 0070.02 Imp. B (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro- H O (A) 100 mg N 2H-1,4-benzodiazepin-2-one Cl N F

MM 0070.03 2-Chloro-10-(2-diethylaminoethyl)-9,10-dihydroacridin-9-one N (A) 100 mg

N

Cl O

MM 0070.06 Flurazepam [Controlled Substance] N (A) 100 mg

O N

Cl N F

New MM 0070.07 2-Hydroxyethylflurazepam HO (A) 50 mg

O N

Cl N

F

110 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Flurbiprofen MM 0727.01 Imp. A (EP): (2RS)-2-(Biphenyl-4-yl)propanoic (A) 50 mg OH Acid O

MM 0727.03 Imp. C (EP): (2RS)-2-(2-Fluorobiphenyl-4-yl)- HO (A) 50 mg 2-hydroxypropanoic Acid F OH O

Flutamide

F F MM 0161.00 H (A) 500 mg N F O NO2 MM 0161.03 Imp. A (EP): 4-Nitro-3-(trifluoromethyl)aniline F F (A) 100 mg H2N F

NO2 F F MM 0161.04 Imp. B (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]acetamide H (A) 100 mg N F O NO2 F F MM 0161.05 Imp. C (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]propanamide H (A) 100 mg N F O NO2 MM 0161.06 Imp. D (EP): 3-(Trifluoromethyl)aniline F F (B) 100 mg H2N F

F F MM 0161.07 Imp. E (EP): 2-Methyl-N-[3-(trifluoromethyl)phenyl]propanamide H (A) 100 mg N F O F F MM 0161.08 Imp. F (EP): 2-Methyl-N-[2-nitro- H (D) 100 mg N 5-(trifluoromethyl)phenyl]propanamide F O O2N HO F F MM 0161.01 2-Hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)- H (A) 100 mg N phenyl]propanamide (2-) F O NO2 MM 0161.09 Trifluoromethylbenzene F F (B) 100 mg F

MM 0161.10 3-Nitrobenzotrifluoride F F (B) 100 mg O2 N F

MM 0161.12 3-Trifluoromethyl-4-nitrophenol F F (A) 100 mg HO F

NO2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 111 Table of content Pharmaceutical impurities

Code Product Price Unit Propionate O MM 1244.10 -Difluoro- -dihydroxy- -methyl- OH (A) 100 mg 3-oxoandrosta-1,4-diene- -carboxylic Acid HO OH

F O F Fluvastatin Sodium MM 0676.00 Fluvastatin Sodium F (D) 100 mg

OH N OH O

ONa Folic Acid

O OH MM 0621.00 Folic Acid O (A) 500 mg O N H N OH N N H O H2N N N H O OH MM 0621.01 Imp. A (EP): (2S)-2-[(4-Aminobenzoyl)amino] O (A) 100 mg pentanedioic Acid (N-(4-Aminobenzoyl)-L-glutamic Acid) N H OH H2N O MM 0621.02 Imp. B (EP) as Sulphate: 2,5,6-Triaminopyrimidin- O (A) 100 mg NH2 4(1H)-one Sulphate N x H2 SO4 H2N N NH2 H MM 0621.04 Imp. D (EP): 4-[[(2-Amino-4-oxo-1,4-dihydropteridin- O (D) 50 mg 6-yl)methyl]amino]benzoic Acid (Pteroic Acid) O OH N N N H H2N N N H MM 0094.03 4-Aminobenzoic Acid O (B) 100 mg OH

H2N MM 0169.00 L-Glutamine NH2 (A) 500 mg H2N OH O O New MM 0621.09 6-Formylpterin O O (D) 50 mg N N

H2N N N H Formoterol Fumarate Dihydrate

OH MM 0447.00 Formoterol Fumarate Dihydrate H (D) 50 mg N

HO O HN O and enantiomer 2 O x HO x 2 H2O OH O New MM 0447.07 Imp. G (EP) as Hydrochloride: (2RS)-1- H2N (A) 100 mg (4-Methoxy-phenyl)propan-2-amine Hydrochloride x HCl [Controlled Substance] O Fumaric Acid New MM 0352.03 Monomethyl Fumarate (A) 100 mg O O

O HO

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Code Product Price Unit Furosemide MM 0014.00 Furosemide O OH (A) 500 mg H N O H 2N S O O Cl MM 0014.02 Imp. A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]- O OH (A) 100 mg 5-sulphamoylbenzoic Acid Cl

H2N S O O HN O MM 0014.03 Imp. B (EP): 2,4-Dichloro-5-sulphamoylbenzoic Acid O OH (B) 100 mg Cl

H 2N S O O Cl MM 0014.01 Imp. C (EP): 2-Amino-4-chloro-5-sulphamoylbenzoic Acid O OH (A) 100 mg NH 2

H 2N S O O Cl MM 0014.04 Imp. D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- O OH (D) 100 mg 5-sulphamoylbenzoic Acid H N O H2N S O O HN O MM 0014.05 Imp. E (EP): 2,4-Dichlorobenzoic Acid O OH (B) 100 mg Cl

Cl MM 0014.50 Ethyl 2,4-Dichloro-5-sulphamoylbenzoate O O (A) 100 mg Cl

H2N S O O Cl Gabapentin MM 0684.01 Imp. A (EP): 2-Azaspiro[4.5]decan-3-one O (A) 100 mg HN (3,3-Pentamethylene-4-butyrolactam)

MM 0684.07 Imp. E (EP): 1-(Carboxymethyl)cyclo- O O (A) 100 mg hexanecarboxylic Acid HO OH

Ganciclovir MM 0485.00 Ganciclovir O (A) 100 mg N HN

N H2N N O OH

HO MM 0061.02 Imp. F (EP): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine) O (B) 100 mg N HN

N H2N N H New MM 0485.08 Imp. H (EP): 2-Amino-7-[[2-hydroxy-1-(hydroxy- HO (A) 50 mg methyl)ethoxy]methyl]-1,7-dihydro-6H-purin-6- O one (N-7 Isomer of Ganciclovir) O OH N HN

N H2N N MM 0485.09 Imp. I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- O (A) 100 mg N 9H-purin-9-yl)methoxy]propane-1,3-diyl HN Dipropanoate (Ganciclovir Dipropionate) N H2N N O O O O

O

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Pharmaceutical impurities

Code Product Price Unit MM 0485.10 Imp. J (EP): 2-[2-(Propanoylamino)-6-oxo- O (A) 100 mg N 1,6-dihydro-9H-purin-9-yl]methoxy] O HN propane-1,3-diyl dipropanoate N (Ganciclovir Tripropionate) N N H O O O O

O Gemcitabine Hydrochloride MM 1257.00 Gemcitabine Hydrochloride NH2 (A) 100 mg N HO O N x HCl O F

OH F MM 0749.05 Imp. A (EP): 4-Aminopyrimidin-2(1H)-one NH2 (A) 100 mg (Cytosine) N

O N H Gemfibrozil MM 0641.00 Gemfibrozil (A) 250 mg O OH O

MM 0641.08 Imp. A (EP): 2,5-Dimethylphenol (p-Xylenol) OH (A) 100 mg

MM 0641.07 (D) 100 mg Imp. E (EP): 5-[2,5-Dimethyl-4-(prop-1-enyl)- O OH phenoxy]-2,2-dimethylpentanoic Acid O MM 0641.02 Imp. H (EP): 1,3-Bis(2,5-dimethylphenoxy)propane O O (A) 100 mg

MM 0641.01 3-(2,5-Dimethylphenoxy)propyl Chloride O Cl (A) 100 mg (3-(2,5-Xylyloxy)propyl Chloride)

MM 0641.03 Gemfibrozil Isobutyl Ester (A) 100 mg O

Gestodene MM 0124.06 Imp. L (EP): 13-Ethyl-17-hydroxy-18,19- OH (A) 100 mg dinor- -pregna-5,15-dien-20-yn-3-one -)

O

GHB Sodium Salt MM 1355.00 GHB Sodium Salt (Sodium Gammahydroxybutyrate) O (A) 100 mg HO [Controlled Substance] ONa Glibenclamide MM 0008.00 Glibenclamide (A) 500 mg O Cl N H O

MM 0008.01 Imp. A (EP): 5-Chloro-2-methoxy-N- (A) 100 mg (2-(4-sulfamoylphenyl)ethyl)benzamide O Cl N H O

MM 0008.02 Imp. B (EP): Methyl [[4-[2-[(5-Chloro- (A) 100 mg 2-methoxybenzoyl)amino]ethyl]phenyl]-sulphonyl]carbamate O Cl N H O

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Code Product Price Unit MM 0942.09 Imp. C (Pharmeuropa): 1-[[4-[2-[(Cyclohexylcarbamoyl)amino]- (A) 100 mg ethyl]phenyl]sulfonyl]-3-cyclohexylurea O (N-(Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino]ethyl] benzene-Sulphonamide) N N H H MM 0008.07 Imp. D (Pharmeuropa): 1-[[4-[2-[(5-Chloro- (A) 50 mg 2-methoxybenzoyl)amino]ethyl]phenyl]-sulfonyl]-3-butylurea O Cl N H O

New MM 0008.08 Imp. E (Pharmeuropa): (A) 50 mg 1-[[4-[2-[(3,5-Di-chloro- O 2-methoxybenzoyl)amino]ethyl]- Cl phenyl]sulfonyl]-3-cyclohexylurea N H O Cl

MM 0008.03 5-Chloro-2-methoxybenzoic Acid O (B) 100 mg Cl OH O

MM 0008.04 5-Chloro-N-(2-phenylethyl)-2-methoxybenzamide O (A) 100 mg Cl N H O

Gliclazide

O MM 0325.00 Gliclazide O O (A) 500 mg S N N N H H

MM 0325.01 Imp. A (EP): 4-Methylbenzenesulphonamide O O (C) 100 mg S NH2

MM 0325.02 Imp. B (EP): 2-Nitroso-octahydrocyclopenta[c]pyrrole (A) 100 mg N N O MM 0325.03 O O O (A) 100 mg Imp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- S Carbamate NO H

MM 0325.06 Imp. F (EP): 1-(Hexahydrocyclopenta[c]pyrrol- (A) 100 mg O O O 2(1H)-yl)-3-[(2-methylphenyl)sulphonyl]urea SN NN HH

MM 0325.09 Methyl N-Methyl-p-tolylsulphoncarbamate O O O (A) 100 mg S NO

Glimepiride

MM 0647.00 Glimepiride O (D) 100 mg S

O N

O N H

MM 0647.02 Imp. A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-oxo-2,3-dihydro-1H-pyrrol- O (D) 100 mg 1-yl)carbonyl]-amino]ethyl]phenyl]sulphonyl]-3-(cis- S 4-methylcyclohexyl)urea (cis-Glimepiride) O N

O N H

MM 0647.01 Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N- (A) 100 mg [2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1H- O pyrrole-1-carboxamide (Glimepiride Sulphonamide) N N H O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 115 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0647.01 Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N- (A) 100 mg [2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1H- O pyrrole-1-carboxamide (Glimepiride Sulphonamide) N N H O

MM 0647.03 Imp. C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl- (A) 100 mg 2-oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]phenyl]- O sulphonyl]carbamate (Glimepiride Carbamate) N N H O

MM 0647.04 Imp. D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo- (D) 100 mg 2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]- phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)- urea H N N O O MM 0647.08 cis-4-Methylcyclohexylamine Hydrochloride (A) 100 mg x HCl H2N Glipizide MM 0942.01 Imp. A (EP): 5-Methyl-N-[2-(4-sulphamoyl- O O (A) 100 mg S phenyl)ethyl]pyrazine-2-carboxamide O NH2 N N H N MM 0678.03 Imp. B (EP): Cyclohexanamine (C) 100 mg

H2N MM 0942.04 Imp. D (EP): 6-Methyl-N- O O (A) 100 mg S [2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide O NH2 N N H N MM 0942.05 Imp. E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl- O O O (A) 100 mg S pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- NN O sulphonyl]urea HH N N H N MM 0942.06 Imp. F (EP): Ethyl [2-(4-Sulphamoylphenyl)- O O (A) 100 mg S ethyl]carbamate O NH2

O N H MM 0942.07 Imp. G (EP): Methyl [[4-[2-[[(5-Methylpyrazin- O O O (A) 100 mg S 2-yl)carbonyl]amino]ethyl]phenyl]- O NO sulphonyl]carbamate H N N H N MM 0942.08 Imp. H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]- O O (A) 100 mg S ethyl]benzenesulphonamide O NH2

N N H H MM 0942.09 Imp. I (EP): N-(Cyclohexylcarbamoyl)- O O O (A) 100 mg S 4-[2-[(cyclohexylcarbamoyl)amino]- NN O ethyl]benzenesulphonamide HH N N H H Glutamine

MM 0169.00 L-Glutamine NH2 (A) 500 mg H2N OH O O

MM 0169.01 N-Phenylacetyl-L-glutamine O (A) 100 mg (Phenylacetylglutamine) HN H2N OH O O MM 0169.02 Phenylacetamide NH2 (A) 100 mg O

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Code Product Price Unit MM 0169.03 D-Glutamine NH2 (A) 100 mg H2N OH O O Glycopyrronium Bromide

MM 0834.00 Glycopyrronium Bromide O (A) 100 mg N+ O Br- OH and enantiomer

MM 0834.05 Imp. B (EP): Oxophenylacetic Acid O (A) 100 mg (Benzoylformic Acid) OH O MM0792.03 Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic O (A) 100 mg Acid (Mandelic Acid) OH OH MM 0278.01 Imp. D (EP): Benzoic Acid (B) 100 mg OH

O MM 0834.07 Imp. H (EP): Methyl 2-oxo-2-Phenylacetate O (A) 100 mg (Methyl Benzoylformate) O O MM 0834.01 Imp. J (EP): 2-(RS)-Cyclopentyl-2-hydroxy- O (A) 100 mg 2-phenylacetic Acid -Cyclopentylmandelic Acid) OH OH

MM 0834.08 Imp. K (EP): (2RS)-2-Cyclopentyl-2-phenyl- O (A) 100 mg acetic Acid OH

MM 0834.06 Imp. M (EP): Cyclopentylphenylmethanone (A) 100 mg O

Granisetron Hydrochloride New MM 0398.02 Imp. B (EP): N-[(1R,3r,5S)-9-Methyl-9-azabicyclo- H (A) 50 mg HN N [3.3.1]non-3-yl]-1H-indazole-3-carboxamide H N N O H New MM 0398.03 Imp. C (EP): N-[(1R,3r,5S)-9-Azabicyclo[3.3.1]non- H (A) 50 mg N N 3-yl]-1-methyl-1H-indazole-3-carboxamide H N NH O H MM 0398.04 Imp. D (EP): 1-Methyl-1H-indazole-3-carboxylic Acid (A) 100 mg N N OH

O MM 0398.07 Imp. G (EP): 2-Methyl-2H-indazole-3-carboxylic Acid N N (A) 100 mg OH

O MM 0398.08 Imp. H (EP): 1H-Indazole-3-carboxylic Acid HN N (A) 100 mg OH

O New MM 0398.09 Imp. I (EP): 1-Methyl-1H-indazole-3-carboxylic (A) 50 mg N N N N Anhydride O

O O Griseofulvin MM 0582.00 Griseofulvin (A) 500 mg Cl O O O O

O O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 117 Table of content Pharmaceutical impurities

Code Product Price Unit Guaiacol MM 0354.04 Guaiacol OH (A) 500 mg

O MM 0814.04 Imp. A (EP): Benzene-1,2-diol (Pyrocatechol) OH (C) 100 mg

OH MM 0045.11 Imp. B (EP): Phenol OH (B) 100 mg

MM 0814.06 Imp. C (EP): 1,2-Dimethoxybenzene (Veratrole) O (C) 100 mg

O MM 0814.08 Imp. E (EP): Methyl Benzoate O (C) 100 mg O

MM 1131.00 Imp. G (EP): 4-Methoxyphenol (Mequinol) OH (A) 500 mg

O MM 0007.09 Imp. H (EP): 3-Methoxyphenol OH (B) 100 mg

O Guaifenesin MM 0354.00 Guaifenesin OH (A) 500 mg O OH

O MM 0354.04 Imp. A (EP): 2-Methoxyphenol (Guaiacol) OH (A) 500 mg

O

MM 0354.01 Imp. B (EP): 2-(2-Methoxyphenoxy)propane-1,3-diol HO OH (A) 100 mg (B-Isomer) O

O MM 0354.02 Imp. C (EP): 1,1'-Oxybis[3-(2-methoxyphenoxy) OH OH (A) 100 mg propan-2-ol] (Bisether) O O O

O O MM 0354.03 Imp. D (EP): 1,3-Bis(2-methoxyphenoxy)propan-2-ol OH (A) 100 mg O O

O O Guanidine Thiocyanate MM 1315.00 Guanidine Thiocyanate NH (A) 100 mg x HS N H2N NH2 Decanoate MM 1276.12 Imp. L (EP): 1-(4-Fluorophenyl)ethanone F (A) 100 mg

O Harpagoside MM 0370.01 Methyl trans-Cinnamate O (B) 100 mg O

Hexetidine MM 0337.03 Imp. C (EP): 2,6-Bis(2-ethylhexyl)-7a-methylhexahydro-1H- (A) 100 mg imidazo[1,5-c]imidazole (Hexedine) N N

Hexylresorcinol MM 0111.00 Hexylresorcinol HO OH (A) 500 mg

MM 0045.11 Imp. A (EP): Phenol OH (B) 100 mg

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Pharmaceutical impurities

Code Product Price Unit MM 0294.01 Imp. B (EP): Resorcinol HO OH (B) 100 mg

Homatropine Methylbromide MM 0792.00 Homatropine Methylbromide H (A) 250 mg O H N+ Br- O OH H and enantiomer MM 0792.03 Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic O (A) 100 mg Acid (Mandelic Acid) OH OH MM 0792.04 Imp. D (EP) as Bromide: (1R,2R,4S,5S,7s)-7-[[(2S)- H H (A) 100 mg O 3-Hydroxy-2-phenylpropanoyl]oxy]-9,9-dimethyl- H N+ O Br- 3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide O (Methylhyoscine Bromide) OH H H MM 0792.06 Imp. F (EP): Methyl (2RS)-2-Hydroxy-2-phenylacetate O (A) 100 mg (Methyl Mandelate) O OH Hydrochlorothiazide MM 0011.00 Hydrochlorothiazide O O O O (A) 500 mg S S H2N NH Cl N H MM 0011.03 Imp. A (EP): Chlorothiazide O O O O (A) 500 mg S S H2N NH Cl N MM 0011.01 Imp. B (EP): 4-Amino-6-chlorobenzene-1,3-disulphonamide O O O O (B) 100 mg S S (Salamide) H2N NH2 Cl NH2 Hydrocodone Hydrogen Tartrate 2.5-Hydrate

New MM 1113.00 Hydrocodone Hydrogen Tartrate 2.5-Hydrate N (A) 100 mg [Controlled Substance] x

O O O

MM 0037.00 Imp. A (EP) as Hydrochloride Trihydrate: N (A) 250 mg Morphine Hydrochloride Trihydrate [Controlled Substance]

HO O OH

MM 0280.00 (A) 250 mg Imp. A (EP) as Hemisulphate Pentahemihydrate: N Morphine Hemisulphate Pentahemihydrate [Controlled Substance]

HO O OH 2

MM 0004.00 Imp. C (EP) as Monohydrate: Codeine Monohydrate N (A) 100 mg [Controlled Substance]

O O OH

MM 0442.00 Imp. C (EP) as Phosphate Hemihydrate: N (A) 100 mg Codeine Phosphate Hemihydrate [Controlled Substance]

O O OH

MM 0672.00 Imp. D (EP) as Hydrochloride: -Epoxy-14- N (A) 100 mg hydroxy-3-methoxy-17-methylmorphinan-6- one Hydrochloride (Oxycodone Hydrochloride) HO x [Controlled Substance] O O O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 119 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0004.02 Imp. E (EP): 7,8-Didehydro- -epoxy-3-methoxy- N (A) 100 mg 17-methylmorphinan-6-one (Codeinone)

O O O MM 0004.03 Imp. F (EP): 7,8-Didehydro- -epoxy- -dimethoxy- N (A) 100 mg 17-methylmorphinan (Methylcodeine; O-Methylcodeine) [Controlled Substance]

O O O MM 0630.01 Imp. H (EP): Diphenylmethanone (Benzophenone) O (B) 100 mg

Hydrocortisone MM 0185.00 Hydrocortisone O (A) 500 mg OH HO OH

O MM 0193.00 Imp. A (EP): Prednisolone O (A) 500 mg OH HO OH

O MM 0214.00 Imp. B (EP): 17,21-Dihydroxypregn-4-ene- O (A) 500 mg OH 3,11,20-trione (Cortisone) O OH

O O MM 0187.00 Imp. C (EP): O (A) 500 mg (Hydrocortisone 21-Acetate) O HO OH

O MM 0185.06 Imp. D (EP): -Tetrahydroxypregn-4- O (A) 100 mg OH ene-3,20- -Hydroxyhydrocortisone) HO OH

O OH MM 0185.07 Imp. E -Trihydroxypregna-4,6- O (D) 100 mg OH diene-3,20-dione (-Hydrocortisone) HO OH

O MM 0185.08 Imp. F (EP): 17,21-Dihydroxypregn-4-ene-3,20-dione O (A) 100 mg OH (Reichstein's Substance S) OH

O MM 0185.13 6α-Hydroxyhydrocortisone O (D) 50 mg OH HO OH

O OH Hydrocortisone Acetate

O MM 0187.00 Hydrocortisone Acetate O (A) 500 mg O HO OH

O MM 0185.00 Imp. A 7,21-Trihydroxy- O (A) 500 mg OH pregn-4-ene-3,20-dione (Hydrocortisone) HO OH

O

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Code Product Price Unit MM 0187.06 Hydrocortisone 11,17,21-Triacetate O (B) 10 mg O O O O O O

O MM 0187.09 -Trihydroxypregna-4,6-diene-3,20-dione 21-Acetate O (D) 100 mg O O HO OH

O O MM 0194.00 Imp. C -Dihydroxy-3,20- O (A) 500 mg dioxopregna-1,4-dien-21-yl Acetate O () HO OH

O O MM 0186.00 Imp. D (Pharmeuropa): 17-Hydroxy-3,11,20- O (A) 500 mg Trioxopregn-4-en-21-yl Acetate O (Cortisone Acetate) O OH

O Hydrocortisone 17-Butyrate

O MM 0188.00 Hydrocortisone 17-Butyrate OH (A) 500 mg HO O O

O MM 0188.01 Hydrocortisone 21-Butyrate O (A) 100 mg O O HO OH

O Hydrocortisone Hydrogen Succinate MM 0185.00 Imp. A (EP): Hydrocortisone O (A) 500 mg OH HO OH

O MM 0187.00 O (A) 500 mg Imp. B (EP): Hydrocortisone Acetate O O HO OH

O Hydromorphone Hydrochloride

New MM 0371.00 Hydromorphone Hydrochloride [Controlled Substance] N (A) 100 mg

x HCl

HO O O MM 0037.00 Imp. C (EP) as Hydrochloride Trihydrate: N (A) 250 mg Morphine Hydrochloride Trihydrate x HCl [Controlled Substance] x 3 H2O

HO O OH MM 0280.00 Imp. C (EP) as Hemisulphate Pentahemi- (A) 250 mg N hydrate: Morphine Hemisulphate Pentahemi- hydrate [Controlled Substance] x H2SO4 x 5 H2O

HO O OH 2 Hydroxychloroquine Sulphate MM 0764.00 Hydroxychloroquine Sulphate Cl N (A) 500 mg x H2SO4

HN OH N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 121 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0764.02 Desethylhydroxychloroquine Dihydrochloride Cl N (D) 100 mg x 2 HCl

HN OH N H MM 0764.04 O-Acetylhydroxychloroquine Cl N (A) 100 mg

HN O N O MM 0764.05 Hydroxychloroquine N-Oxide Dihydrochloride Cl N (B) 10 mg

x 2 HCl HN OH N O

Hydroxyethyl Salicylate MM 0112.00 Hydroxyethyl Salicylate O (A) 500 mg OH O

OH MM 0045.00 Imp. A (EP): Salicylic Acid O (A) 500 mg OH

OH Hydroxyzine Hydrochloride

Cl O MM 0852.00 Hydroxyzine Hydrochloride N OH (A) 250 mg N x 2 HCl

Cl MM 0380.01 Imp. A (EP): (RS)-1-[(4-Chlorophenyl) NH (A) 100 mg phenylmethyl]piperazine N

O MM 0852.02 Imp. B (EP) as Dihydrochloride: N OH (A) 50 mg 2-[2-[4-(Diphenylmethyl)piperazin-1-yl]ethoxy]- N ethanol Dihydrochloride x 2 HCl (Decloxizine Dihydrochloride)

Hymechromone MM 0294.00 Hymecromone HO O O (A) 500 mg

MM 0294.01 Imp. A (EP): 1,3-Dihydroxybenzene (Resorcinol) HO OH (B) 100 mg

MM 0294.02 Imp. B (EP): 7-Hydroxy-2-methyl-4H-1-benzopyran-4-one HO O (A) 100 mg

O MM 0294.03 2,4-Dihydroxyacetophenone HO OH (B) 100 mg O

MM 0294.04 Hymecromone Acetate O O O (A) 100 mg O

MM 0294.50 7-Acetoxy-3-acetyl-2-4H-1-benzopyran-4-one O O (A) 100 mg O O O

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Code Product Price Unit Hyoscine Butylbromide MM 0683.00 Hyoscine Butylbromide H (A) 500 mg O H + N O Br O

OH H

MM 0546.00 Imp. A (EP) as Hydrobromide Trihydrate: H H (A) 500 mg O Hyoscine Hydrobromide Trihydrate H x HBr N O x 3 H2O O H OH H MM 0601.03 Imp. B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic O (A) 100 mg Acid (DL-Tropic Acid; Tropic Acid) OH

OH Hyoscine Hydrobromide MM 0546.00 Hyoscine Hydrobromide Trihydrate H H (A) 500 mg O H x HBr N O O x 3 H2O H OH H MM 0546.06 Imp. C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa- H H (A) 100 mg O 9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- H N O 2-enoate (Apohyoscine) O H H MM 0601.03 Imp. D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic O (A) 100 mg Acid (DL-Tropic Acid; Tropic Acid) OH

OH MM 0546.07 Hyoscine N-Oxide Hydrobromide H H (A) 100 mg O H N O x HBr O O H OH H Hyoscyamine Sulphate

MM 0601.03 Imp. A (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid O (A) 100 mg (DL-Tropic Acid; Tropic Acid) OH

OH MM 0546.00 Imp. D (EP) as Hydrobromide Trihydrate: H H (A) 500 mg O Hyoscine Hydrobromide Trihydrate H x HBr N O x 3 H2O O H OH H MM 0289.01 Imp. G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl- H (D) 100 mg O 8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate H N x HCl Hydrochloride (Apoatropine Hydrochloride) O H Ibandronate Sodium Monohydrate MM 1326.00 Ibandronate Sodium Monohydrate OH (A) 100 mg O P OHHO x H2OOH N P ONa O Ibuprofen MM 0002.00 Ibuprofen (A) 500 mg OH O MM 0002.13 Imp. A (EP): (2RS)-2-[3-(2-Methylpropyl)phenyl]propanoic Acid (A) 100 mg OH O MM 0002.01 Imp. B (EP):(2RS)-2-(4-Butylphenyl)propanoic Acid (A) 100 mg OH O MM 0002.10 Imp. C (EP): (2RS)-2-[4-(Methylpropyl)phenyl]propanamide (A) 100 mg NH2 O

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Code Product Price Unit MM 0002.11 Imp. D (EP): (2RS)-2-(4-Methylphenyl)propanoic Acid (A) 100 mg OH O

MM 0002.04 Imp. E (EP): 1-[4-(2-Methylpropyl)phenyl]ethanone O (A) 100 mg

MM 0002.28 Imp. F (EP): 3-[4-(2-Methylpropyl)phenyl]propanoic Acid O (A) 100 mg OH

MM 0002.38 Imp. G (EP): (1RS,4RS)-7-(2-Methylpropyl)-1- O OH (D) 50 mg [4-(2-methylpropyl)phenyl]-1,2,3,4-tetrahydro- naphthalene-1,4-dicarboxylic Acid

OH O

and enantiomer MM 0002.30 Imp. H (EP):(3RS)-1,3-Bis[4-(2-methylpropyl) O (D) 100 mg phenyl]butan-1-one

MM 0002.31 Imp. I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3- (A) 50 mg [4-(2-methylpropyl)phenyl]butyl]benzene

MM 0002.02 Imp. J (EP): (2RS)-2-[4-(2-Methylpropanoyl)phenyl] (A) 100 mg OH propanoic Acid O O MM 0002.26 Imp. K (EP): (2RS)-2-(4-Formylphenyl) (A) 100 mg OH propanoic Acid O O MM 0002.24 Imp. L (EP): 2-[4-(1-Hydroxy-2-methylpropyl)phenyl] (A) 100 mg OH propanoic Acid (1-Hydroxyibuprofen) O OH MM 0002.34 Imp. M (EP): (2RS)-2-Hydroxy- OH (A) 100 mg 2-[4-(2-methylpropyl)phenyl]propanoic Acid OH O MM 0002.35 Imp. N (EP): (2RS)-2-(4-Ethylphenyl)propanoic Acid (A) 100 mg OH O MM 0002.33 Imp. O (EP): 2-[4-(1-Methylpropyl)phenyl]propanoic Acid (A) 100 mg OH O

MM 0002.19 Imp. P (EP):(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-ol (A) 100 mg OH

MM 0002.36 Imp. Q (EP): 2-[4-(2-Methylpropyl)phenyl]ethanol OH (A) 100 mg

MM 0002.37 Imp. R (EP): 1,1'-(Ethane-1,1-diyl)-4,4'-(2- (A) 100 mg methylpropyl)dibenzene

MM 0002.03 4-Isobutylbenzoic Acid O (A) 100 mg OH

MM 0002.07 2-(4-Isobutyrylphenyl)propanamide (A) 100 mg NH2 O O MM 0002.08 4-Acetylbenzoic Acid O (A) 100 mg OH

O MM 0002.09 4-Isobutyrylacetophenone O (A) 100 mg

O MM 0002.14 2-(4-Isobutyrylphenyl)propane (A) 100 mg

O

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Code Product Price Unit MM 0002.15 2-Hydroxypropyl 2-(4-Isobutylphenyl)propanoate OH (A) 100 mg O O MM 0002.16 1-Hydroxyprop-2-yl 2-(4-Isobutylphenyl)propanoate on request O OH O

MM 0002.17 2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)propanoate OH (D) 50 mg O OH O MM 0002.18 1,3-Dihydroxyprop-2-yl 2-(4-Isobutylphenyl)propanonate on request O OH O OH MM 0002.20 2-(4-n-Propylphenyl)propanoic Acid (A) 100 mg OH O MM 0002.21 2-(4-Isobutylphenyl)propionitrile (A) 100 mg N

MM 0002.23 Isopropyl 2-(4-Isobutylphenyl)propanonate (A) 100 mg O O MM 0002.25 1-Ethyl-4-isobutylbenzene (A) 100 mg

MM 0002.29 (1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl- O OH (D) 100 mg propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 1,4-dicarboxylic Acid

OH O

and enantiomer MM 0002.32 2-[4-(2-Hydroxy-2-methylpropyl)phenyl]propanoic Acid (A) 100 mg (2-Hydroxyibuprofen) OH O HO MM 0002.45 (2SR)-2-(4-Isobutylphenyl)-N-((SR)- (A) 100 mg H 1-phenylethyl)propanamide N O and enantiomer MM 0002.46 (2SR)-2-(4-Isobutylphenyl)-N-((RS)- (A) 100 mg H 1-phenylethyl)propanamide N O and enantiomer MM 0002.48 4-Isobutylstyrene (B) 10 mg

MM 0002.50 1-(4-Isobutylphenyl)ethanol (A) 100 mg OH

MM 0002.51 4-(1-Hydroxy-2-methylpropyl)acetophenone O (A) 100 mg

OH New MM 0002.56 Ibuprofen Ethyl Ester (A) 100 mg O

O MM 0002.53 Ibuprofen Methyl Ester (A) 100 mg O O MM 0002.57 1-(4-Isopropylphenyl)ethanone O (A) 100 mg (4-Isopropylacetophenone)

MM 0002.59 2-(4-Isopropylphenyl)acrylic Acid (C) 50 mg OH O

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Code Product Price Unit Idoxuridine MM 0791.00 Idoxuridine O (A) 500 mg I HN HO O N O

OH Imidocarb Dipropionate

MM 0742.00 Imidocarb Dipropionate O O (A) 100 mg H H N N x2 N N OH H H N N Imipramine Hydrochloride MM 0077.00 Imipramine Hydrochloride (A) 500 mg

x HCl N N

MM 0589.00 Imp. A (EP) as Hydrochloride: 3-(10,11-Dihydro- (A) 250 mg 5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1- x HCl amine Hydrochloride (Desipramine Hydrochloride) N N H

MM 0077.05 Imp. B (EP): 3-(5H-Dibenzo[b,f]azepin-5-yl)-N,N- (A) 100 mg dimethylpropan-1-amine (Depramine; 10,11-Dehydroimipramine) N N

MM 0077.08 Imp. C (EP) as Hydrochloride: (A) 100 mg 10-[3-(Dimethylamino)propyl]acridin-9(10H)-one N N Hydrochloride x HCl O

MM 0077.03 N-[3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5-yl) (B) 10 mg propyl]-N,N',N'-trimethylpropane-1,3-diamine Dihydrochloride N N N

x 2 HCl

MM 0077.04 10-Hydroxyimipramine BH3-Aduct (A) 100 mg

N N x BH3

HO MM 0076.06 Iminodibenzyl (B) 100 mg

NH

MM 0077.12 Imipramine N-Oxide (A) 100 mg

N N O

Indanazoline Hydrochloride MM 0588.02 4-Aminoindan Hydrochloride (A) 100 mg x HCl

NH2 Indapamide

MM 0477.00 Indapamide O O (A) 250 mg O S N N H2 N H Cl MM 0477.01 Imp. A (EP): (2RS)-2-Methyl-1-nitroso- (A) 100 mg 2,3-dihydro-1H-indole N ON

126 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0477.02 Imp. B (EP): 4-Chloro-N-(2-methyl-1H- O O (A) 100 mg O S N indol-1-yl)-3-sulphamoylbenzamide N H2N H Cl

O O MM 0477.04 4-Chloro-3-sulfamoylbenzoic Acid O (C) 100 mg S OH H2N Cl

O O MM 0477.05 N-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindoline O (D) 100 mg S N H2 N Cl MM 0477.07 Triethylamine (C) 100 mg N MM 0477.08 2-Methylindoline (A) 100 mg HN

MM 0477.09 1-Amino-2-methylindoline Hydrochloride (D) 100 mg x HCl N H2N Indometacin MM 0584.00 Indometacin O (A) 500 mg OH N O Cl

O MM 0063.03 Imp. A (EP): 4-Chlorobenzoic Acid O (B) 100 mg OH Cl MM 0584.02 3,4-Dichloroindometacin ([1-(3,4-Dichlorobenzoyl)- O (A) 50 mg Cl OH 5-methoxy-2-methylindol-3-yl]acetic Acid) N O Cl

O Indoramin Hydrochloride MM 0802.02 Imp. A (BP): 3-(2-Bromoethyl)indole H (A) 100 mg N

Br New MM 0802.05 Imp. B (BP): N-(1-Benzyl-4-piperidyl)- (A) 50 mg H benzamide N

N O Ipecacuanha

MM 0131.02 Emetine Dihydrochloride N (A) 100 mg x 2 HCl H O O HN O O Ipratropium Bromide

MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic O (A) 100 mg Acid (dl-Tropic Acid) OH

OH MM 0289.03 Imp. D (EP): 2-Phenylpropenoic Acid (Atropic Acid) O (A) 100 mg

OH

Iprindole Hydrochloride MM 0478.00 Iprindole Hydrochloride (A) 100 mg N N x HCl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 127 Table of content Pharmaceutical impurities

Code Product Price Unit Irbesartan MM 0862.01 Imp. A (EP): 1-(Pentanoylamino)-N-[[2'-(1H- O N N (A) 50 mg tetrazol-5-yl)biphenyl-4-yl]methyl]cyclo- HN N N pentanecarboxamide H NH O

Isoamyl Benzoate MM 1086.00 Isoamyl Benzoate O (A) 500 mg O

Isoconazol Nitrate MM 0541.00 Isoconazole Nitrate Cl (A) 100 mg

Cl Cl x HNO3 O N Cl N MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2- (A) 100 mg N (1H-imidazol-1-yl)ethanol N HO Cl Cl MM 0541.02 Imp. B (EP) as Nitrate: (2RS)-2-[(2,6-Dichlorobenzyl)oxy]- Cl (D) 100 mg 2-(2,4-dichlorophenyl)ethanamine Nitrate

Cl Cl x HNO3 O NH2 Cl MM 0281.00 Imp. C (EP) as Nitrate: 1-[(2RS)- Cl (A) 500 mg 2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]- 1H-imidazole Nitrate ( Nitrate) Cl x HNO3 O N Cl Cl N Isoflurane MM 0500.02 Imp. B (EP): 2-(Difluoromethoxy)-1,1,1-trifluoroethane F (A) 100 mg F O F F F MM 0500.03 Imp. C (EP): (2RS)-2-Chloro-2-(chlorodifluoromethoxy)- Cl F F (A) 100 mg F 1,1,1-trifluoroethane O Cl F F MM 0500.04 Imp. D (EP): 1,1-Dichloro-1-(difluoromethoxy)-2,2,2-trifluoroethane Cl Cl F (A) 100 mg F O F F F MM 0500.05 Imp. E (EP): 1,1-Dichloro-1-(chlorodifluoromethoxy)-2,2,2- Cl Cl F F (A) 100 mg F trifluoroethane O Cl F F MM 0500.06 Imp. F (EP): Acetone O (C) 100 mg

Isoproturon MM 2503.02 3-(2-Isopropylphenyl)-1,1-dimethylurea (A) 100 mg H N N O

MM 2503.03 3-(3-Isopropylphenyl)-1,1-dimethylurea H (A) 100 mg N N O Isosorbide Dinitrate

O NO2 MM 0126.05 Imp. B (EP): Isosorbide 2-Nitrate H (A) 100 mg O

O HO H

128 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0502.00 Imp. C (EP): Isosorbide Mononitrate (Isosorbide 5-Nitrate) H OH (A) 500 mg O

O H O2 N O

MM 0126.01 2-Monomethyl Isosorbide H O on request O

O HO H MM 0126.02 Dimethyl Isosorbide H O (B) 100 mg O

O O H OH MM 0126.03 Isosorbide H (A) 500 mg O

O HO H O NO2 MM 0126.04 Isomannit initrate H on request O

O H O2 N O Isosorbide Mononitrate

MM 0502.00 Isosorbide Mononitrate H OH (A) 500 mg O

O H O2 N O

O NO2 MM 0126.05 Imp. C (EP): Isosorbide 2-Nitrate H (A) 100 mg O

O HO H MM 0126.03 Isosorbide H OH (A) 500 mg O

O HO H Isoxsuprine Hydrochloride

MM 0576.00 Isoxsuprine Hydrochloride OH (A) 500 mg H N O x HCl HO and enantiomere Itraconazole MM 0258.00 Itraconazole (A) 100 mg N N O N

N

N and enantiomer

Cl Cl O

O O N N N MM 0258.02 Imp. A (EP): 4-[4-[4-(4-Methoxyphenyl)piperazin- (A) 100 mg 1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro- N N 3H-1,2,4-triazol-3-one N O

N

N

O

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Code Product Price Unit MM 0258.04 Imp. C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- (A) 100 mg 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- N N methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- O 2,4-dihydro-3H-1,2,4-triazol-3-one N

N

N and enantiomer

Cl Cl O O O N N N MM 0258.05 Imp. D (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- (A) 100 mg 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- N N methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1- methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one N O

N

N and enantiomer

Cl Cl O O O N N N MM 0258.07 Imp. F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichloro- (A) 100 mg phenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan- N N 4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4- O dihydro-3H-1,2,4-triazol-3-one N

N

N and enantiomer

Cl Cl O O O N N N MM 0258.10 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]- N NH (A) 100 mg 3H-1,2,4-triazol-3-one O N

N

N

O MM 0258.11 cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)- and enantiomer (A) 100 mg 1,3-dioxolane-4-methanol Mesilate Cl Cl O O S O N O O N N Ketamine Hydrochloride

MM 0144.00 Ketamine Hydrochloride O (A) 500 mg NH x HCl Cl

MM 0144.01 Imp. A (EP): 1-[(2-Chlorophenyl)- N Cl (A) 100 mg (methylimino)methyl]cyclopentanol HO

130 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit O MM 0144.02 Imp. B (EP): (2RS)-2-(2-Chloro- OH Cl (A) 100 mg phenyl)-2-hydroxycyclohexanone

O New MM 0144.07 Dehydronorketamine Hydrochloride Cl (A) 50 mg NH2 x HCl

Ketoconazole MM 0145.00 Cl Cl (A) 500 mg O

O O N N N O N and enantiomer

MM 0145.04 Imp. D (EP): 1-[4-[[(2RS,4SR)- Cl Cl (A) 100 mg 2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)- O 1,3-dioxolan-4-yl]methoxy]phenyl]piperazine O O N N N HN and enantiomer MM 0145.05 1-Acetyl-4-(4-hydroxyphenyl)piperazine O (A) 100 mg N N OH

Ketoprofen MM 0001.00 Ketoprofen O (A) 500 mg OH O MM 0001.01 Imp. A (EP):1-(3-Benzoylphenyl)ethanone O O (A) 100 mg (3-Acetylbenzophenone)

MM 0001.03 Imp. B (EP): (3-Benzoylphenyl)acetic Acid O (A) 100 mg OH O

MM 0001.07 Imp. C (EP):3-[(1RS)-1-Carboxylethyl]benzoic Acid O (A) 100 mg OH HO O

MM 0001.12 Imp. D (EP): (2RS)-2-[3-(4-Methylbenzoyl)phenyl] O (D) 100 mg propanoic Acid OH O

MM 0001.05 Imp. E (EP):(2RS)-2-(3-Benzoylphenyl)propanamide O (A) 100 mg NH2 O

MM 0001.04 Imp. F (EP): (2RS)-2-(3-Benzoylphenyl)propanenitrile O (A) 100 mg N

MM 0001.20 Imp. G (EP): 3-[(1RS)-1-Cyanoethyl]benzoic Acid O (A) 100 mg HO N

MM 0001.22 Imp. H (EP): 3-(Cyanomethyl)benzoic Acid O (A) 100 mg HO N

MM 0001.14 Imp. I (EP): (3-Benzoylphenyl)ethanenitrile O (A) 100 mg

N

MM 0001.23 Imp. J (EP): (2RS)-2-[3-(2,4-Dimethylbenzoyl)- O (D) 50 mg phenyl]propanoic Acid OH O MM 0001.02 3-Ethylbenzophenone O (A) 100 mg

MM 0001.11 3-(1-Hydroxyethyl)benzophenone O OH (A) 100 mg

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Code Product Price Unit MM 0001.13 3-Methylbenzophenone O (B) 100 mg

MM 0001.17 3-(1-Methoxyethyl)benzophenone O O (A) 100 mg

MM 0001.18 2-[3- -Hydroxybenzyl)phenyl]propanoic Acid OH (A) 100 mg OH O

MM 0001.19 Ethyl 2-(3-Benzoylphenyl)propionate O (A) 100 mg (Ketoprofen Ethyl Ester) O O MM 0001.21 Isopropyl 2-(3-Benzoylphenyl)propionate O (A) 100 mg O O MM 0001.50 3-(1-Acetoxyethyl)benzophenone O O (A) 100 mg O

MM 0001.32 Methyl 2-(3-Benzoylphenyl)propionate O (A) 100 mg (Ketoprofen Methyl Ester) O O

MM 0001.33 2-Ethylhexyl 2-(3-Benzoylphenyl)propionate O (A) 100 mg (Ketoprofen 2-Ethylhexyl Ester) O

O Ketorolac Trometamol O MM 0851.00 Ketorolac Trometamol OH (A) 250 mg OH x NH 2 N HO OH O MM 0851.03 Imp. I (EP): Phenyl(2,3-dihydro-1H-pyrrolizin- (A) 100 mg 5-yl)methanone N O Ketotifen Hydrogen Fumarate

MM 0180.00 Ketotifen Hydrogen Fumarate S N (A) 250 mg O HO O x OH O

MM 0180.04 Ketotifen S N (A) 100 mg

O

MM 0180.08 Imp. B (EP): (4RS)-10-Methoxy-4-(1-methyl- S N (A) 100 mg piperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2- b]thiophen-4-ol O OH

MM 0180.07 Imp. D (EP): 4-[(aRaS)-1-Methylpiperidin-4- O (A) 100 mg ylidene]-4,9-dihydro-10H-benzo[4,5]- S N cyclohepta[1,2-b]thiophen-10-one N-Oxide (Ketotifen N-Oxide) O

MM 0180.11 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-one S (A) 100 mg O O

New MM 0180.12 N-Desmethylketotifen Hydrogen Fumarate S NH (A) 50 mg O x HO O OH O

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Code Product Price Unit Labetalol Hydrochloride

MM 0438.00 Labetalol Hydrochloride OH (A) 500 mg H N x HCl HO

O NH2

New MM 0438.01 Imp. A (EP) as Hydrochloride: 2-Hydroxy- OH (A) 50 mg H 5-[1-hydroxy-2-[(1-methyl-3-phenyl- N propyl)-amino]ethyl]benzoic x HCl Acid Hydrochloride HO

O OH Lacidipine MM 0407.00 Lacidipine H (A) 100 mg N O O O O O O

MM 0407.01 Imp. A (BP): Ethyl Methyl (E)-4-{2-[2-(tert- H (A) 100 mg N Butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6- dimethyl-pyridine-3,5-dicarboxylate O O O O O O

MM 0407.02 Imp. B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxy- N (A) 100 mg carbonyl)vinyl]phenyl}-2,6-dimethylpyridine- O O 3,5-dicarboxylate O O O O

Lamivudine MM 0749.00 Lamivudine NH2 (A) 100 mg N

O N

O S HO MM 0045.00 Imp. C (EP): Salicylic Acid O (A) 500 mg OH

OH MM 0749.05 Imp. E (EP): 4-Aminopyrimidin-2(1H)-one(Cytosine) NH2 (A) 100 mg N

O N H MM 0593.03 Imp. F (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil) O (C) 100 mg HN

O N H

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Code Product Price Unit Lamotrigine

N NH2 MM 0922.00 Lamotrigine N (A) 100 mg N

NH2 Cl Cl N NH2 MM 0922.01 Imp. A (EP): 3-Amino-6-(2,3-dichlorophenyl)- N (A) 100 mg 1,2,4-triazin-5(4H)-one NH

O Cl Cl N NH2 MM 0922.03 Imp. C (EP): (2Z)-[2-(Diaminomethylidene)- N (A) 100 mg diazanylidene](2,3-dichlorophenyl)acetonitrile NH2 N Cl Cl MM 0922.04 Imp. D (EP): 6-(2,3-Dichlorophenyl)-1,2,4- H (A) 50 mg N O triazine-3,5(2H,4H)-dione N NH

O Cl Cl MM 0922.05 Imp. E (EP): 2,3-Dichlorobenzoic Acid O (A) 100 mg OH

Cl Cl N NH2 MM 0922.07 Imp. G (EP): 6-(2,4-Dichlorophenyl)-1,2,4- Cl N (A) 50 mg triazine-3,5-diamine N

NH2 Cl Lansoprazole MM 0474.00 Lansoprazole (A) 100 mg NH F F O N S F O N MM 0474.07 Imp. A (EP): 2-[(RS)-[[3-Methyl-1-oxido- (D) 100 mg 4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]- NH F F O sulphinyl]-1H-benzimidazole N S F (Lansoprazole N-Oxide) O N O MM 0474.01 Imp. B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro- (A) 100 mg ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H- NH F F O benzimidazole (Lansoprazole Sulphone) N S F O O N MM 0474.06 Imp. C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro- (A) 100 mg ethoxy)pyridin-2-yl]methyl]sulphanyl]-1H- NH F F O benzimidazole N S F N MM 0474.03 Imp. D (EP): 1H-Benzimidazol-2-ol (B) 100 mg NH

N OH MM 0474.05 Imp. E (EP): 1H-Benzimidazole-2-thiol (A) 100 mg NH

N SH MM 0474.02 Imp. F (EP): 2-[(RS)-[(4-Chloro-3-methylpyridin- (A) 100 mg 2-yl)methyl]sulphinyl]-1H-benzimidazole NH Cl N S O N

MM 0474.04 4-Ethoxyacetophenone O (C) 100 mg

O MM 0474.08 Lansoprazole Sulphone N-Oxide (A) 100 mg NH F F O N S F O O N O MM 0474.09 2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy F F (A) 100 mg O pyridine Hydrochloride Cl F x HCl N

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Code Product Price Unit MM 0474.13 1-Methyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a] S (D) 100 mg O benzimidazol-2(12H)-one N N N Leflunomide N MM 0859.00 Leflunomide H (D) 100 mg O N O F F F MM 0859.01 Imp. A (EP) as Hydrochloride: 4-(Trifluoro- H2N (A) 100 mg methyl)aniline Hydrochloride F x HCl F F MM 0859.02 Imp. B (EP): (2Z)-2-Cyano-3-hydroxy-N-[4- N (A) 100 mg (trifluoromethyl)phenyl]but-2-enamide H (Teriflunomide) N OH O F F F N MM 0859.03 Imp. C (EP): 5-Methyl-N-[3-(trifluoromethyl)- F F (A) 100 mg O H phenyl]isoxazole-4-carboxamide N F O MM 0859.04 Imp. D (EP): 5-Methylisoxazole-4-carboxylic Acid N (A) 100 mg O OH

O MM 0859.05 Imp. E (EP): 3-Methyl-N-[4-(trifluoromethyl)phenyl] N (A) 50 mg isoxazole-4-carboxamide O H N O F F F F MM 0859.06 Imp. F (EP): 5-Methyl-N-[2-(trifluoromethyl)- F (A) 100 mg N phenyl]isoxazole-4-carboxamide F O H N O MM 0859.07 Imp. G (EP): 5-Methyl-N-(4-methylphenyl)- N (A) 100 mg O H isoxazole-4-carboxamide N

O MM 0859.08 Imp. H (EP): 2-Cyano-N-[4-(trifluoromethyl)- N (A) 50 mg phenyl]acetamide H N O F F F Letrozole New MM 1143.02 Imp. A (EP): 4,4'-(4H-1,2,4-Triazol-4-ylmethylene)- N N (A) 50 mg dibenzonitrile

N

N N Levamisole Hydrochloride MM 0706.00 Levamisole Hydrochloride N S (A) 100 mg x HCl N MM 0706.04 Imp. D (EP): 6-Phenyl-2,3-dihydro-imidazo[2,1-b]thiazole N S (A) 100 mg N Levetiracetam New MM 1372.00 Levetiracetam O (A) 50 mg N NH2 O Levocetirizine Dihydrochloride MM 1035.00 Levocetirizine Dihydrochloride O (D) 100 mg Cl O N OH N

x 2 HCl

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Code Product Price Unit Levodopa MM 0262.00 Levodopa O (A) 500 mg HO OH NH 2 HO MM 0634.00 Imp. B (EP): (2S)-2-Amino-3-(4-hydroxy- O (A) 100 mg phenyl)propanoic Acid (Tyrosine) OH NH2 HO MM 0262.05 Imp. C (EP): (2RS)-2-Amino-3-(4-hydroxy- O (A) 100 mg 3-methoxyphenyl)propanoic Acid (3-Methoxy-DL-tyrosine; OH (DL)-3-O-Methyldopa) NH2 HO O MM 0262.06 4-Hydroxy-3-methoxymandelic Acid OH (A) 100 mg OH

O HO O Levodropropizine

MM 1246.02 Imp. B (EP) as Hydrochloride: 1-Phenyl- NH (A) 100 mg piperazine Hydrochloride N x HCl

Levofloxacin

MM 0846.00 Levofloxacin N O (A) 100 mg N N

OH F O O Levomenthol MM 0388.00 Levomenthol OH (A) 500 mg

Levomepromazine Hydrochloride MM 0266.00 Levomepromazine Hydrochloride (A) 500 mg

N N x HCl S

O Levomepromazine Maleate

MM 0019.00 Levomepromazine Maleate O (A) 100 mg

N N OH x S OH

O O MM 0019.02 Imp. A (EP): 2-Methoxyphenothiazine (A) 100 mg

NH S

O MM 0019.01 Imp. B (EP): 10-[(2R)-3-(Dimethylamino)-2- (A) 100 mg methylpropyl]-2-methoxy-10H-phenothiazine 5-Oxide (Levomepromazine S-Oxide) N N S O

O MM 0019.07 N-Demethyllevomepromazine Hydrochloride (D) 100 mg

N N H x HCl S

O MM 0019.09 Levomepromazine Sulphone Hydrochloride (A) 100 mg

N N x HCl O S O O

136 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0121.00 Levonorgestrel OH (A) 250 mg

O MM 0121.08 Imp. G (Pharmeuropa): 13-Ethyl- - OH (D) 50 mg dihydroxy-18,19-dinor- -pregn-4-en- 20-yn-3- -Hydroxylevonorgestrel) O OH MM 0121.01 Imp. H (Pharmeuropa): 13-Ethyl- - OH (D) 100 mg dihydroxy-18,19-dinor- -pregn-4-en- 20-yn-3- -Hydroxylevonorgestrel) O OH MM 0121.02 Imp. J (Pharmeuropa): 13-Ethyl-17-hydroxy- OH (D) 100 mg 18,19-dinor- -pregn-4-en-20-yn-3,6-dione (6-Oxolevonorgestrel, 6-Ketolevonorgestrel)

O O MM 0121.12 Imp. L (Pharmeuropa): 13-Ethylgon-4-ene-3,17- O (D) 100 mg dione (Levodione, 18-Methyl-19-norandrost-4- ene-3,17-dione)

O MM 0121.11 Imp. M (Pharmeuropa): 13-Ethyl-17-hydroxy- OH (D) 100 mg 18,19-dinor- -pregna-4,6-dien-20-yn-3-one -Levonorgestrel, 6,7-Didehydrolevonorgestrel)

O Lidocaine Hydrochloride

MM 0102.04 Lidocaine Hydrochloride Monohydrate H (A) 500 mg N x HCl N x H2O O

MM 0102.00 Lidocaine H (A) 500 mg N N O MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline (B) 100 mg NH2

MM 0102.01 Imp. B (EP): 2-(Diethylazinoyl)-N-(2,6- H O (A) 100 mg N N dimethylphenyl)acetamide (Lidocaine N2- Oxide) O

MM 0102.08 Imp. C (EP): N-(2,6-Dimethylphenyl)acetamide H (A) 100 mg N O

MM 0102.05 Imp. D (EP) as Hydrochloride: N-(2,6- H (A) 100 mg N Dimethylphenyl)-2-(ethylamino)acetamide N x HCl H Hydrochloride (Monoethylglycinexylidide O Hydrochloride) Imp. E (EP) as Hydrochloride: 2,2'- MM 0102.09 (Azanediyl)bis[N-(2,6-dimethylphenyl)- H H (A) 100 mg N N acetamide] Hydrochloride N x HCl H O O

MM 0102.10 Imp. F (EP) as Hydrochloride: 2-(Diethyl- H (A) 100 mg N amino)-N-(2,3-dimethylphenyl)acetamide N x HCl Hydrochloride O

MM 0102.11 Imp. G (EP) as Hydrochloride: N-(2,6- H (A) 100 mg N Dimethylphenyl)-2-[(1-methylethyl)amino]- N x HCl H acetamide Hydrochloride O

MM 0102.03 Imp. H (EP): 2-Chloro-N-(2,6-dimethylphenyl)acetamide H (B) 100 mg N Cl O MM 0102.12 Imp. I (EP) as Hydrochloride: 2-(Diethylamino)- H (A) 100 mg N N-(2,4-dimethylphenyl)acetamide Hydrochloride N x HCl O MM 0102.13 Imp. J (EP) as Hydrochloride: 2-(Diethylamino)- H (A) 50 mg N N-(2,5-dimethylphenyl)acetamide Hydrochloride N x HCl O

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Code Product Price Unit MM 0102.14 Imp. K (EP) as Hydrochloride: N-(2,6-Dimethyl- H (A) 100 mg N phenyl)-2-(ethylmethylamino)acetamide Hydro- N x HCl chloride O Liothyronine Sodium MM 0626.00 Liothyronine Sodium I (A) 50 mg O NH2 ONa HO I I O MM 0626.01 Liothyronine I (A) 100 mg O NH2 OH HO I I O Lisinopril Dihydrate O MM 0598.00 Lisinopril Dihydrate O OH (A) 100 mg H N N x 2 H2O HO O H2N MM 0598.01 Imp. A (EP): (2RS)-2-Amino-4-phenylbutanoic Acid (A) 100 mg NH2

HO O MM 0598.02 Imp. B (EP) as Hydrate: 4-Methylbenzenesulphonic Acid Hydrate O O (C) 100 mg S OH x H2O

Lomustine

MM 0923.02 Imp. B (EP): 1-(2-Chloroethyl)-3-cyclohexylurea O (A) 100 mg Cl N N H H MM 0923.03 Imp. C (EP): 1,3-Dicyclohexylurea O (A) 100 mg

N N H H Loperamide Hydrochloride MM 0025.00 Loperamide Hydrochloride Cl (A) 500 mg OH

N x HCl

N

O

MM 0025.14 Imp. A (EP): 4-[4-(4'-Chlorobiphenyl-4-yl)-4- Cl (A) 50 mg hydroxypiperidin-1-yl]-N,N-dimethyl-2,2- diphenylbutanamide OH

N

N

O

MM 0025.15 Imp. B (EP) as Bromide: 4-(4-Chlorophenyl)- on request N O 1,1-bis[4-(dimethylamino)-4-oxo- 3,3-diphenylbutyl]-4-hydroxypiperidinium Bromide OH

N+ Br- Cl

N

O

MM 0025.04 Imp. C (EP): 4-(4-Chlorophenyl)piperidin-4-ol Cl (B) 100 mg OH

N H

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Code Product Price Unit MM 0025.05 Imp. D (EP): 4-(4-Hydroxy-4-phenylpiperidin-1-yl)- (A) 100 mg N,N-dimethyl-2,2-diphenylbutanamide OH

N

N

O

MM 0025.09 Imp. F (EP): Loperamide Oxide Cl (A) 100 mg OH

N O

N

O

MM 0025.11 Imp. H (EP): 4-[4-(4-Chlorophenyl)-3,6- Cl (A) 100 mg dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2- diphenylbutanamide

N

N

O

MM 0025.07 Ethyl Diphenylacetate (A) 100 mg

O

O MM 0025.08 (A) 100 mg  O

O

MM 0025.10 Dimethyl-(tetrahydro-3,3-diphenyl-2-furilidine) (A) 100 mg O ammonium Bromide Br- N+

Loratadine

O MM 0257.00 Loratadine Cl (A) 100 mg N O

N

O MM 0257.03 Imp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11- Cl (A) 100 mg hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- N O hepta[1,2-b]pyridin-11-yl]piperidine-1- OH carboxylate N

MM 0257.02 Imp. B (EP): 8-Chloro-5,6-dihydro-11H- Cl (A) 100 mg benzo[5.6]cyclohepta[1,2-b]pyridin-11-one O

N

O MM 0257.08 Imp. C (EP): Ethyl 4-(4,8-Dichloro-5,6-dihydro- Cl (D) 100 mg 11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11- N O ylidene)piperidine-1-carboxylate

N

Cl

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Code Product Price Unit MM 0257.01 Imp. D (EP): 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H- Cl (A) 50 mg benzo[5,6]cyclohepta[1,2-b]pyridine (Descarboethoxyloratadine; NH Desloratadine)

N

MM 0257.05 Imp. G (EP): 8-Chloro-11-(1-methylpiperidin-4- Cl (A) 100 mg ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta- N [1,2-b]pyridine

N

MM 0257.07 Imp. H (EP): Ethyl 4-Oxopiperidine-1-carboxylate O (A) 100 mg N O

O MM 0257.06 (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin-4-yl)- Cl (A) 100 mg 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine N OH

N

Lorazepam MM 0071.00 Lorazepam [Controlled Substance] H O (A) 100 mg N OH Cl N

Cl

MM 0071.01 Imp. A (EP): (2-Amino-5-chlorophenyl)(2-chlorophenyl) NH2 (B) 100 mg methanone (2-Amino-2',5-dichlorobenzophenone) O Cl Cl

MM 0071.07 Imp. B (EP): (3RS)-7-Chloro-5-(2-chlorophenyl)- H O (A) 100 mg N 2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate O (Lorazepam Acetate) Cl N [Controlled Substance] O Cl

MM 0071.06 Imp. C (EP): 7-Chloro-5-(2-chlorophenyl)- H O (A) 100 mg N 1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide Cl N O Cl

MM 0071.03 Imp. D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- H O (A) 100 mg N 4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione O Cl NH

Cl

MM 0071.02 Imp. E (EP): 6-Chloro-4-(2-chlorophenyl)- O (A) 100 mg quinazoline-2-carbaldehyde N N Cl Cl

MM 0071.04 6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxylic Acid O (A) 100 mg N OH N Cl Cl

MM 0071.08 6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol OH (A) 100 mg N

N Cl Cl

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Code Product Price Unit MM 0071.09 6-Chloro-4-(2-chlorophenyl)-2(1H)-quinazolinone H (A) 100 mg N O N Cl Cl

Lormetazepam

New MM 0072.00 Lormetazepam [Controlled Substance] O (A) 100 mg N OH Cl N

Cl

Losartan Potassium

OH MM 0168.00 Losartan N N on request NNH N Cl N

MM 0168.14 Imp. B (Pharmeuropa) : [2'-(1H-Tetrazol-5-yl) N N (A) 50 mg biphenyl-4-yl]methanol HN N HO

MM 0168.04 Imp. C (Pharmeuropa) : [2-Butyl-5-chloro-1-[[2'- Cl N N (D) 50 mg (1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol- HN N N 4-yl]methanol HO N

MM 0168.08 Imp. D (EP) : 2-Butyl-4-chloro-1H-imidazole-5-carbaldehyde O (A) 100 mg

NH Cl N

MM 0168.05 Imp. E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-tetrazole N N (A) 50 mg HN N

MM 0168.15 Imp. F (EP) : 5-[4'[[2-Butyl-4-chloro-5-[[(1- O (A) 100 mg N N methylethyl)oxy]methyl]-1H-imidazol-1-yl]- HN N methyl]biphenyl-2-yl]-1H-tetrazole (Losartan N Isopropyl Ether) Cl N

MM 0173.04 Imp. G (EP) : Triphenylmethanol (A) 100 mg OH

MM 0168.16 Imp. H (EP) : [2-Butyl-4-chloro-1-[[2'-[2- (A) 100 mg (triphenylmethyl)-2H-tetrazol-5-yl]biphenyl- 4-yl]methyl]-1H-imidazol-5-yl]methanol OH N N N N N Cl N

New MM 0168.17 Imp. I (Pharmeuropa) : 5-[4'-[[2-Butyl-4-chloro- (A) 50 mg 5-[[(triphenylmethyl]oxy]methyl]-1H-imidazol- 1-yl]methyl]biphenyl-2-yl]-1H-tetrazole O N N HN N N Cl N

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 141 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0168.18 Imp. J (EP) : [2-Butyl-4-chloro-1-[[2'-(1H- O (A) 100 mg tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- O imidazol-5-yl]methyl Acetate N N HN N N Cl N

MM 0168.11 Losartan Butyl Ether (A) 50 mg O N N HN N N Cl N

O MM 0168.12 Losartan Methyl Ether N N (A) 100 mg HN N N Cl N

Lovastatin MM 0050.00 Lovastatin O (A) 100 mg O OH H O O

MM 0377.00 Imp. A (EP): (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy- O (A) 100 mg 6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a- O hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Mevastatin) OH O O

MM 0050.01 Imp. B (EP) as Sodium Salt: (3R,5R)-7-[(1S,2S,6R,8S,8aR)- O (A) 100 mg 2,6-Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a- OH ONa hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium OH H Salt (Lovastatin Hydroxy Acid Sodium Salt) O O

MM 0050.03 Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo- O (A) 100 mg 3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen- O 1-yl (2S)-2-Methylbutanoate (Dehydrolovastatin) H O O

Malic Acid MM 1332.01 Imp. A (EP): (E)-Butenedioic Acid (Fumaric Acid) O (B) 100 mg HO OH O Maprotiline Hydrochloride MM 0820.00 Maprotiline Hydrochloride (A) 250 mg

N x HCl H

MM 0820.01 Imp. A (EP): 3-(9,10-Ethanoanthracen-9(10H)-yl)prop-2-enal (A) 50 mg

O

MM 0820.02 Imp. B (EP) as Hydrochloride: (C) 10 mg 3-(9,10-Ethanoanthracen-9(10H)-yl)-N- N [3-(9,10-ethanoanthracen-9(10H)-yl)propyl]-N- x HCl methylpropan-1-amine Hydrochloride

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Code Product Price Unit MM 0820.03 Imp. C (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen- (C) 10 mg 9(10H)-yl)propan-1-amine Hydrochloride NH 2 x HCl

MM 0820.04 Imp. D (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen- (A) 50 mg 9(10H)-yl)-N-methylprop-2-en-1-amine Hydrochloride N (Dehydromaprotiline Hydrochloride) H x HCl

MM 0820.05 Imp. E (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen- (A) 100 mg 9(10H)-yl)-N,N-dimethylpropan-1-amine Hydrochloride N x HCl

Mebendazole MM 0882.02 Imp. B (EP): (2-Hydroxy-1H-benzimidazol-5- H (A) 50 mg N yl)phenylmethanone OH N O MM 0882.04 Imp. D (EP): Methyl (5-Benzoyl-1-methyl-1H- O (A) 50 mg benzimidazol-2-yl)carbamate N O NH N O O MM 0882.05 Imp. E (EP): Ethyl (5-Benzoyl-1H-benzimidazol- H (A) 50 mg 2-yl)carbamate N O NH N O O MM 0882.06 Imp. F (EP): Methyl [5-(4-Methylbenzoyl)-1H- H (A) 50 mg benzimidazol-2-yl]carbamate N O NH N O Mebeverine Hydrochloride

MM 0319.00 Mebeverine Hydrochloride O (A) 100 mg N O

O O O x HCl MM 0319.02 Imp. A (Pharmeuropa): 4-Methoxyphenylacetone O (B) 100 mg

O MM 0319.03 Imp. B (Pharmeuropa) as Hydrochloride: N-[(1RS)- (A) 100 mg 1-[(4-Methoxyphenyl)methyl]ethyl]ethanamine NH x HCl Hydrochloride [Controlled Substance] O MM 0319.01 Imp. D (Pharmeuropa): 3,4-Dimethoxybenzoic Acid O (B) 100 mg (Veratric Acid) HO

O O Mechlorethamine Hydrochloride MM 0823.00 Mechlorethamine Hydrochloride (A) 500 mg N x HCl Cl Cl

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Code Product Price Unit Meclofenoxate Hydrochloride MM 0044.00 Meclofenoxate Hydrochloride O (A) 500 mg O N O x HCl Cl MM 0044.02 (4-Chlorophenoxy)acetic Acid O (B) 100 mg O OH Cl Meclozine Hydrochloride MM 0586.00 Meclozine Dihydrochloride (A) 500 mg

N x 2 HCl N Cl MM 0380.09 Imp. B (EP): (RS)-(4-Chlorophenyl)phenyl- (B) 100 mg methanol (4-Chlorobenzhydrol)

OH

Cl MM 0380.10 Imp. C (EP): (4-Chlorophenyl)phenyl- (B) 100 mg methanone (4-Chlorobenzophenone)

O

Cl MM 0586.08 Imp. D (EP): 1,1'- (A) 50 mg (1,3-Phenylenebismethylene)- bis[4-[(4-chlorophenyl)phenylmethyl] piperazine] N N Cl

N N Cl MM 0586.09 Imp. E (EP): 1-(Diphenylmethyl)-4-[(3-methyl- (A) 50 mg phenyl)methyl]piperazine

N N MM 0380.04 Imp. F (EP): 1,4-Bis[(4-chlorophenyl)phenyl- (A) 100 mg methyl]-piperazine

Cl N N Cl

MM 0380.01 Imp. H (EP): 1-[(RS)-(4-Chlorophenyl)phenyl- (A) 100 mg methyl]piperazine ((RS)-1-[(4-Chlorophenyl)- phenylmethyl]piperazine) N NH Cl MM 0586.05 Meclozine N-Oxide (B) 10 mg

N N Cl O MM 0586.07 N-(3-Methylbenzyl)piperazine Dihydrochloride (A) 100 mg HN x 2 HCl N Medroxyprogesterone MM 0635.00 Medroxyprogesterone O (A) 100 mg OH

O

144 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Medroxyprogesterone Acetate MM 0532.00 Medroxyprogesterone Acetate O (A) 100 mg O O

O

MM 0532.01 Imp. A -Hydroxy-6-methyl-3,20-dioxopregn-4- O (D) 100 mg en-17- -Hydroxymedroxyprogesterone Acetate) O O

O OH MM 0635.00 Imp. B (EP):17-Hydroxy- -methylpregn-4-ene-3,20-dione O (A) 100 mg (Medroxyprogesterone) OH

O

MM 0532.05 Imp. E (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl O (A) 100 mg Acetate (6-Methylenehydroxyprogesterone Acetate) O O

O

MM 0532.06 Imp. F -Methyl-3,20-dioxo- -pregnan-17-yl Acetate O (D) 50 mg -Dihydromedroxyprogesterone Acetate) O O

O H MM 0532.07 Imp. G (EP): 6-Methyl-3,20-dioxopregna-4,6-dien-17-yl O (A) 250 mg Acetate () O O

O

MM 0532.09 Imp. H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate O (A) 100 mg (Hydroxyprogesterone Acetate) O

O

O Mefenamic Acid MM 0327.00 Mefenamic Acid O (A) 500 mg OH

NH

MM 0327.01 Imp. A (EP): 2,3-Dimethylaniline NH2 (B) 100 mg

MM 0327.02 Imp. B (EP): N-(2,3-Dimethylphenyl)- (A) 100 mg 2-[(2,3-dimethylphenyl)amino]benzamide O

N H NH

MM 0217.14 Imp. C (EP): 2-Chlorobenzoic Acid O (A) 100 mg OH

Cl MM 0278.01 Imp. D (EP): Benzoic Acid O (B) 100 mg OH

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Code Product Price Unit Mefloquine Hydrochloride F MM 1198.01 2,8-Bis-(trifluoromethyl)-4-quinolinol F (A) 100 mg F F F N F

OH Megestrol Acetate MM 0532.07 Megestrol Acetate O (A) 250 mg O

O

O

MM 0532.00 Imp. A (EP): -Methyl-3,20-dioxopregn-4-en-17-yl O (A) 100 mg Acetate (Medroxyprogesterone Acetate) O

O

O

MM 0532.09 Imp. K (Pharmeuropa): 3,20-Dioxopregn-4-en-17-yl O (A) 100 mg Acetate O

O

O Melatonin New MM 1373.00 Melatonin O (A) 100 mg HN

O

N H Meloxicam MM 0246.00 Meloxicam O O (A) 500 mg S N H N N OH O S

MM 0084.03 Imp. A (EP): Ethyl 4-Hydroxy-2-methyl- O O (A) 100 mg S 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N O OH O

H2N MM 0246.01 Imp. B (EP): 5-Methylthiazol-2-amine N (A) 100 mg S

MM 0246.16 Imp. C (EP): N-[(2Z)-3,5-Dimethylthiazol-2(3H)- O O (A) 50 mg S ylidene]-4-hydroxy-2-methyl-2H-1,2-benzothiazine- N 3-carboxamide 1,1-Dioxide N N OH O S

MM 0246.17 Imp. D (EP): N-[(2Z)-3-Ethyl-5-methylthiazol-2(3H)-ylidene]- O O (A) 50 mg S 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide N 1,1-Dioxide N N OH O S

MM 0084.02 Imp. E (EP): Methyl 4-Hydroxy-2-methyl- O O (A) 100 mg S 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N O OH O MM 0084.12 Imp. F (EP): Isopropyl 4-Hydroxy-2-methyl-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxylate 1,1-Dioxide N (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2- O benzothiazine-3-carboxylate 1,1-Dioxide) OH O

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Code Product Price Unit Melperone

MM 0321.00 Melperone O (A) 100 mg N

F Memantine Hydrochloride MM 1045.01 1-Hydroxy-3,5-dimethyladamantane OH (A) 100 mg

MM 1045.04 1-Chloro-3,5-dimethyladamantane Cl (A) 100 mg

Mephenesin MM 0810.00 Mephenesin OH (A) 500 mg O OH

Mephentermine Hemisulphate

MM 0740.00 Mephentermine Hemisulfate H (A) 500 mg N x ½ H2 SO4

Mepivacaine Hydrochloride MM 0368.00 Mepivacaine Hydrochloride (A) 500 mg H N x HCl N O MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline (B) 100 mg NH2

MM 0368.02 Imp. B (EP) as Hydrochloride: (RS)-N-(2,6- (A) 50 mg H Dimethylphenyl)piperidine-2-carboxamide N x HCl N Hydrochloride H O MM 0368.03 Imp. C (EP): N-(2,6-Dimethylphenyl)pyridine-2-carboxamide (A) 100 mg H N N O MM 0368.07 Imp. E (EP): (RS)-N-(4-Chloro-2,6-dimethyl- (A) 50 mg H phenyl)-1-methylpiperidine-2-carboxamide N N O Cl MM 0368.06 Mepivacaine N-Oxide (A) 100 mg H N N O O Mepyramine Maleate

MM 0559.00 Mepyramine Maleate O (A) 500 mg N N OH x O N OH O

MM 0559.02 Imp. A (EP): N-(4-Methoxybenzyl)pyridin-2-amine NH (A) 100 mg

O N

MM 0164.03 Imp. B (EP): 4-Methoxybenzaldehyde (Anisaldehyde) O (C) 100 mg O MM 0084.01 Imp. C (EP): Pyridin-2-amine NH 2 (B) 100 mg N

MM 0559.05 Mepyramine N-Oxide Dihydrochloride O (A) 100 mg N N x 2 HCl O N

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Code Product Price Unit Mequinol MM 1131.00 Mequinol O (A) 500 mg

HO Mesalazine MM 0217.00 Mesalazine O (A) 500 mg H2N OH

OH MM 0042.01 Imp. A (EP): 4-Aminophenol H2N (B) 100 mg

OH MM 0042.07 Imp. B (EP): 3-Aminophenol (B) 100 mg

H2N OH MM 0217.06 Imp. C (EP): 2-Aminophenol (A) 100 mg

OH NH2 MM 0217.07 Imp. D (EP): 3-Aminobenzoic Acid O (A) 100 mg OH

NH2 MM 0217.09 Imp. F (EP): 3-Amino-2-hydroxybenzoic O (A) 100 mg Acid (3-Aminosalicylic Acid) OH

OH NH2 MM 0217.10 Imp. G (EP): 2,5-Dihydroxybenzoic Acid O (A) 100 mg HO OH

OH MM 0045.00 Imp. H (EP): 2-Hydroxybenzoic Acid O (A) 500 mg (Salicylic Acid) OH

OH MM 0217.12 Imp. I (EP): 2-Hydroxy-5-(phenyldiazenyl)benzoic Acid O (A) 50 mg (Phenylazosalicylic Acid) N N OH

OH MM 0093.17 Imp. K (EP) as Hydrochloride: Aniline Hydrochloride H2N (B) 100 mg x HCl

MM 0217.14 Imp. L (EP): 2-Chlorobenzoic Acid O (A) 100 mg OH

Cl MM 0217.15 Imp. M (EP): 2-Chloro-5-nitrobenzoic Acid O (A) 100 mg O2N OH

Cl MM 0217.16 Imp. N (EP): 2-Hydroxy-5-nitrobenzoic Acid O (A) 100 mg O2N (5-Nitrosalicylic Acid) OH

OH MM 0227.04 Imp. O (Pharmeuropa): 4-Aminobenzene- H2N (A) 100 mg sulphonic Acid (Sulphanilic Acid) OH S O O MM 0217.02 5-Acetaminosalicylic Acid O OH (A) 100 mg OH O N H Metamizole Sodium

O O MM 0052.00 Metamizole Sodium Monohydrate O (A) 500 mg N S N ONa x H2O N

MM 0052.02 Imp. A (EP): 4-Formylamino-1,5-dimethyl-2-phenyl-1,2- O H (A) 100 mg O dihydro-3H-pyrazol-3-one (4-Formylaminophenazone) N N N

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Code Product Price Unit MM 0052.04 Imp. B (EP): 4-Amino-1,5-dimethyl-2-phenyl-1,2-dihydro- O (A) 100 mg NH2 3H-pyrazol-3-one (Ampyrone) N N

MM 0052.10 Imp. C (EP) as Hydrochloride: 4-Methylamino-1,5-dimethyl- O H (A) 100 mg N 2-phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride N x HCl (4-Methylaminophenazone Hydrochloride) N

MM 0052.05 Imp. D (EP): 4-Dimethylamino-1,5-dimethyl-2-phenyl-1,2- O (A) 100 mg dihydro-3H-pyrazol-3-one (4,4-Dimethylaminophenazone) N N N

MM 0052.01 4-Acetylaminophenazone O H (A) 100 mg N O N N

MM 0052.50 4-Benzylideneaminoantipyrine (A) 100 mg O N N N

Metformin Hydrochloride MM 0056.00 Metformin Hydrochloride NH NH (A) 500 mg x HCl H2 N N N H NH MM 0056.01 Imp. A (EP): Cyanoguanidine N (B) 100 mg H2N N H MM 0056.07 Imp. B (EP) as Nitrate: (4,6-Diamino-1,3,5- NH2 (A) 100 mg triazin-2-yl)guanidine Nitrate N N NH x HNO3

H2N N N NH2 H MM 0056.03 Imp. C (EP): N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine (A) 100 mg H2 N N N N N NH2

MM 0056.04 Imp. D (EP): 1,3,5-Triazine-2,4,6-triamine (Melamine) H2 N N NH2 (B) 100 mg N N NH2 MM 0056.05 Imp. E (EP) as Hydrochloride:1-Methylbiguanide Hydrochloride NH NH (A) 100 mg x HCl H2 N N N H H MM 0056.06 Imp. F (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride H (C) 100 mg N x HCl Methadone Hydrochloride

New MM 0531.00 Methadone Hydrochloride [Controlled Substance] N (A) 100 mg

x HCl

O

MM 0531.04 Imp. C (EP) as Hydrochloride: (3RS)-4-(Dimethyl- N (A) 50 mg amino)-3-methyl-2,2-diphenylbutanenitrile Hydro- chloride (Isodidiavalo Hydrochloride) x HCl N

MM 0531.06 Imp. E (EP): Diphenylacetonitrile (A) 100 mg N

Methamphetamine Hydrochloride MM 0964.00 Methamphetamine Hydrochloride H (A) 100 mg N [Controlled Substance] x HCl

New MM 0964.03 rac-Methamphetamine Hydrochloride H (A) 100 mg N [Controlled Substance] x HCl

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Code Product Price Unit Methaqualone New MM 1356.00 Methaqualone [Controlled Substance] N (A) 100 mg N

O Methohexital New MM 1347.00 Methohexital (A) 100 mg O N O

NH

O Methotrexate O OH MM 0040.00 Methotrexate O (A) 500 mg

NH 2 N H N OH N N O H 2N N N MM 0040.08 Imp. A (EP) as Hydrochloride: (2,4-Diaminopteridin- NH 2 (A) 100 mg N 6-yl)methanol Hydrochloride N OH x HCl

H2N N N Methoxsalen

MM 0555.00 Methoxsalen O (A) 500 mg O O O

MM 0555.01 5-Methoxypsoralen (Bergapten) O O O (A) 100 mg

O Methoxyphenamine Hydrochloride MM 0655.00 Methoxyphenamine Hydrochloride H (A) 500 mg N x HCl O

Methyl Nicotinate MM 0549.00 Methyl Nicotinate O (A) 500 mg N O

MM 0553.00 Imp. A (EP): Nicotinic Acid O (A) 500 mg N OH

Methyl Parahydroxybenzoate MM 0431.00 Methyl Parahydroxybenzoate O (A) 500 mg O HO MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg OH HO MM 0498.00 Imp. B (EP): Ethyl 4-Hydroxybenzoate O (A) 500 mg (Ethyl Parahydroxybenzoate) O HO MM 0432.00 Imp. C (EP): Propyl 4-Hydroxybenzoate O (A) 500 mg (Propyl Parahydroxybenzoate) O HO MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate O (A) 500 mg (Butyl Parahydroxybenzoate) O HO MM 0431.01 Sodium Methyl Parahydroxybenzoate O (A) 500 mg O NaO

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Code Product Price Unit Methylphenidate Hydrochloride New MM 1031.00 Methylphenidate Hydrochloride [Controlled Substance] O O (A) 100 mg H N x HCl H and enantiomer MM 1031.04 Ritalinic Acid O OH (A) 100 mg H N

New MM 1031.11 Ritalinic Acid Hydrochloride O OH (A) 100 mg H N x HCl

Methylprednisolone

O MM 0190.00 OH (A) 100 mg HO OH

O

MM 0190.01 O (D) 50 mg Imp. A (EP): 17,21-Dihydroxy-6-methylpregna- OH 1,4-diene-3,11,20-trione O OH

O

Methylprednisolone Acetate

MM 0191.00 Methylprednisolone Acetate O (D) 100 mg O O HO OH

O

O MM 0190.00 Imp. B (EP): Methylprednisolone OH (A) 100 mg HO OH

O

MM 0194.00 Imp. E (EP): Prednisolone Acetate O (A) 500 mg O O HO OH

O Methylprednisolone Hydrogen Succinate MM 0192.00 Methylprednisolone Hydrogen Succinate Sodium Salt O on request O ONa O HO OH O

O

MM 0190.00 O (A) 100 mg Imp. A (EP): Methylprednisolone OH HO OH

O

MM 0191.00 Imp. C (EP): Methylprednisolone Acetate O (D) 100 mg O O HO OH

O

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Code Product Price Unit MM 0558.00 Methyltestosterone OH (A) 250 mg

O MM 0323.00 OH (A) 500 mg

O Metixene Hydrochloride MM 0125.01 Imp. A (EP): 9H-Thioxanthene (A) 100 mg

S

MM 0125.02 Imp. B (EP): 9H-Thioxanthen-9-one (B) 100 mg (Thioxanthone) O

S

MM 0125.03 3-Chloromethyl-1-methylpiperidine Cl on request

N

Metoclopramide

MM 0073.00 Hydrochloride Monohydrate O (A) 500 mg Cl N N x HCl H x H2O H2N O

MM 0073.03 Imp. A (EP): 4-(Acetylamino)-5-chloro-N- O (A) 100 mg [2-(diethylamino)ethyl]-2-methoxybenzamide Cl N O N H N O H MM 0073.04 Imp. B (EP): Methyl 4-(Acetylamino)-5-chloro- O (A) 100 mg Cl 2-methoxybenzoate O O N O H MM 0073.02 Imp. C (EP): 4-Amino-5-chloro-2-methoxybenzoic Acid O (B) 100 mg Cl OH H2 N O MM 0073.05 Imp. D (EP): Methyl 4-(Acetylamino)-2-methoxybenzoate O (A) 100 mg O O N O H MM 0073.01 Imp. E (EP): N,N-Diethylethane-1,2-diamine (B) 100 mg N H2 N

MM 0073.06 Imp. F (EP): 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]- O (A) 100 mg 2-hydroxybenzamide Cl N N H H2 N OH

MM 0073.07 Imp. G (EP): N'-(4-Amino-5-chloro-2-methoxybenzoyl)-N,N- O (A) 100 mg diethylethane-1,2-diamine N-Oxide (Metoclopramide N-Oxide) Cl N N O H H2 N O MM 0073.08 Imp. H (EP): 4-(Acetylamino)-2-hydroxybenzoic Acid O (A) 100 mg O OH N OH H MM 0073.09 Methyl 4-Amino-2-hydroxybenzoate O (A) 100 mg O H2 N OH MM 0073.10 Methyl 4-(Acetylamino)-2-hydroxybenzoate O (A) 100 mg O O N OH H

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Code Product Price Unit Metoprolol Succinate OH MM 0279.00 Metoprolol Succinate H (A) 100 mg O N

O 2 O x HO OH O OH MM 0027.04 Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)- H (A) 100 mg phenoxy]propan-2-ol O N O MM 0027.01 Imp. B (EP): 4-(2-Methoxyethyl)phenol OH (A) 100 mg

O

MM 0027.24 Imp. C (EP) as Hydrochloride: 4-[(2RS)-2- OH H (A) 100 mg O N Hydroxy-3-[(1-methylethyl)amino]propoxy]- x HCl benzaldehyde Hydrochloride O

MM 0027.06 Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy] OH (A) 100 mg propane-1,2-diol O OH O OH MM 0027.07 Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)phenoxy]- H (A) 100 mg 3-[(1-methylethyl)amino]propan-2-ol O N O OH MM 0027.08 Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]-3- H (A) 100 mg phenoxy-propan-2-ol O N

MM 0027.09 Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol OH (A) 100 mg

HO OH MM 0027.10 Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]- H (A) 100 mg 3-[(1-methylethyl)amino]propan-2-ol O N HO OH MM 0027.11 (2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]- H (A) 100 mg propan-2-ol O N

OH OH MM 0027.12 Imp. J (EP): 1-[2-Hydroxy- H (A) 50 mg 3-[(1-methylethyl)amino]propoxy]- O O N 3-[4-(2-methoxyethyl)phenoxy]propan-2-ol O OH MM 0027.13 (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]- H (A) 100 mg 3-[(1methylethyl)amino]propan-2-ol O N O

OH MM 0027.28 Imp. M (EP) as Dihydrochloride: H H (A) 100 mg 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride N N x 2 HCl

OH MM 0027.16 Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol H (A) 100 mg HO N

MM 0027.03 Imp. O (EP): 1,1'-[(1-Methylethyl)imino]bis- OH OH (A) 100 mg [3-[4-(2-methoxyethyl)phenoxy]propan-2-ol] O N O

O O Metoprolol Tartrate OH MM 0027.00 Metoprolol Tartrate H (A) 500 mg O N

O 2 OH O x HO OH O OH OH MM 0027.04 Imp. A (EP): (2RS)-1-(Ethylamino)- H (A) 100 mg 3-[4-(2-methoxyethyl)phenoxy]propan-2-ol O N O MM 0027.01 Imp. B (EP): 4-(2-Methoxyethyl)phenol OH (A) 100 mg

O

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Code Product Price Unit

MM 0027.24 Imp. C (EP) as Hydrochloride: 4-[(2RS)-2- OH H (A) 100 mg O N Hydroxy-3-[(1-methylethyl)amino]propoxy]- x HCl benzaldehyde Hydrochloride O

MM 0027.06 Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy] OH (A) 100 mg propane-1,2-diol O OH O OH MM 0027.07 Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)- H (A) 100 mg phenoxy]-3-[(1-methylethyl)amino]propan-2-ol O N O OH MM 0027.08 Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]- H (A) 100 mg 3-phenoxypropan-2-ol O N

MM 0027.09 Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol OH (A) 100 mg HO OH MM 0027.10 Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- H (A) 100 mg phenoxy]-3-[(1-methylethyl)amino]propan-2-ol O N HO OH MM 0027.11 (2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino] H (A) 100 mg propan-2-ol O N

OH OH MM 0027.12 Imp. J (EP): 1-[2-Hydroxy- H (A) 50 mg 3-[(1-methylethyl)amino]propoxy]-3-[4- O O N (2-methoxyethyl)phenoxy]propan-2-ol O OH MM 0027.13 (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]- H (A) 100 mg 3-[(1methylethyl)amino]propan-2-ol O N O

OH MM 0027.28 Imp. M (EP) as Dihydrochloride: H H (A) 100 mg 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride N N x 2 HCl

OH MM 0027.16 Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol H (A) 100 mg HO N

MM 0027.03 Imp. O (EP): 1,1'- OH OH (A) 100 mg [(1-Methylethyl)imino]bis- O N O [3-[4-(2-methoxyethyl)phenoxy]propan- 2-ol] O O

O MM 0027.02 1-[4-(2-Methoxyethyl)phenoxy]-2,3-epoxypropane O (A) 100 mg

O MM 0027.17 1-Chloro-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol OH (A) 100 mg O Cl

O MM 0027.18 4,4'-(2-Hydroxy-1,3-propandiyldioxy)- OH (A) 100 mg bis[(2-methoxyethyl)benzene)] O O O O MM 0027.22 3-Chloropropane-1,2-diol OH (B) 100 mg Cl OH

MM 0027.26 1-[2-(2-Methoxyethyl)phenyoxy]-2,3-epoxypropane O (C) 50 mg O O

Metronidazole

MM 0012.00 Metronidazole O2N (A) 500 mg OH N N MM 0012.02 Imp. A (EP): 2-Methyl-4-nitroimidazole NH (B) 100 mg O 2N N MM 0012.05 Imp. B (EP): 4-Nitroimidazole NH (C) 100 mg O2N N OH MM 0012.06 Imp. C (EP): 2-(4-Nitro-1H-imidazol-1-yl)ethanol N (A) 100 mg O2 N N MM 0012.07 Imp. D (EP): 2-(5-Nitro-1H-imidazol-1-yl)ethanol O2 N (A) 100 mg OH N N OH MM 0012.01 Imp. E (EP): 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethanol N (A) 100 mg O2N N

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Code Product Price Unit MM 0012.09 Imp. G (EP): 2-(2-Methyl-5-nitro-1H- O2N (A) 100 mg OH imidazol-1-yl)acetic Acid N O N MM 0012.04 1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole O2N (A) 100 mg OH (Hydroxymetronidazole) N N OH Metronidazole Benzoate MM 0278.00 Metronidazole Benzoate (A) 100 mg O2 N O N O N MM 0012.00 Imp. A (EP): Metronidazole O2N (A) 500 mg OH N N MM 0012.02 Imp. B (EP): 2-Methyl-5-nitroimidazole O2N (B) 100 mg (2-Methyl-4-nitroimidazole) NH N MM 0278.01 Imp. C (EP): Benzoic Acid O (B) 100 mg OH

MM 0278.04 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethyl Benzoate (A) 100 mg O N O2 N O N Mevastatin MM 0377.00 Mevastatin O (A) 100 mg O OH O O

Mexiletine Hydrochloride MM 0146.00 Mexiletine Hydrochloride NH2 (A) 500 mg O x HCl

MM 0146.01 Imp. A (EP): 2,6-Dimethylphenol (A) 100 mg OH

MM 0146.02 Imp. B (EP): 1-(2,6-Dimethylphenoxy)propan-2-one O (A) 100 mg O

MM 0146.06 Imp. D (EP) as Hydrochloride: (2RS)-2-(2,6-Di- (A) 50 mg O methylphenoxy)propan-1-amine Hydrochloride NH2 x HCl

Mianserin Hydrochloride MM 0147.00 Mianserin Hydrochloride (A) 100 mg N N x HCl

MM 0147.01 Imp. A (EP): [2-[(2RS)-4-Methyl-2-phenyl- (A) 100 mg N piperazin-1-yl]phenyl]methanol N

OH

MM 0147.04 Imp. C (EP): (2-Aminophenyl)methanol H2N (B) 100 mg

OH New MM 0147.05 Imp. E (EP) as Hydrochloride: (14bRS)- HN (A) 50 mg 1,2,3,4,10,14b-Hexahydrodibenzo[c,f]pyrazino[1,2- N a]azepine Hydrochloride x HCl (Desmethylmianserin Hydrochloride)

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Code Product Price Unit MM 0147.06 Mianserin N-Oxide O (D) 100 mg N

N

Miconazole Nitrate MM 0281.00 Miconazole Nitrate Cl (A) 500 mg

Cl x HNO3 O N Cl Cl N MM 0074.00 Miconazole Cl (A) 250 mg

Cl

O N Cl Cl N MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2- Cl (A) 100 mg (1H-imidazol-1-yl)ethanol

Cl

HO N

N MM 0524.00 Imp. B (EP) as Nitrate: 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]- Cl (A) 500 mg 2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Econazole Nitrate) Cl x HNO3 O N Cl N MM 0281.03 Imp. C (EP) as Nitrate: (2RS)-2-[(2,4-Dichlorobenzyl)oxy]- Cl (D) 100 mg 2-(2,4-dichlorophenyl)ethanamine Nitrate

Cl x HNO3 O NH2 Cl Cl MM 0541.00 Imp. D (EP) as Nitrate: 1-[(2RS)-2-[(2,6-Dichlorobenzyl)oxy]- Cl (A) 100 mg 2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Isoconazole Nitrate) Cl Cl x HNO3 O N Cl N MM 0281.06 Imp. F (EP) as Nitrate: 1-[(2RS)- Cl (A) 100 mg 2-[(3,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]- 1H-imidazole Nitrate Cl x HNO3 O N Cl Cl N MM 0281.07 Imp. G (EP) as Nitrate: 1-[(2RS)- Cl (A) 100 mg 2-[(2,5-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]- 1H-imidazole Nitrate Cl x HNO3 Cl O N Cl N MM 0281.08 Imp. H (EP) as Nitrate: 1-[(2RS)-2-Benzyloxy- Cl (A) 100 mg 2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate

Cl x HNO3 O N

N

156 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0281.09 Imp. I (EP) as Nitrate: 1-[(2RS)-2-[(2-Chlorobenzyl)- Cl (A) 100 mg oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate

Cl x HNO3 O N Cl N MM 0281.10 1-(2,4-Dichlorobenzoylmethyl)imidazole Cl (A) 100 mg

Cl

O N

N Midazolam New MM 1106.00 Midazolam [Controlled Substance] N (A) 100 mg N

Cl N

F

MM 0070.02 Imp. F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3- H O (A) 100 mg N dihydro-2H-1,4-benzodiazepin-2-one (1-Des[(diethylamino)ethyl]flurazepam) Cl N

F

Minoxidil MM 0521.00 Minoxidil (A) 500 mg N N NH2 N O NH2 MM 0521.01 Imp. A (EP): 6-Chloropyrimidine-2,4-diamine 3-Oxide Cl N NH2 (A) 100 mg N O NH2 MM 0521.02 Imp. B (EP): 6-Chloropyrimidine-2,4-diamine Cl N NH2 (C) 100 mg N

NH2 MM 0521.05 Imp. E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-diamine (A) 100 mg (Desoxyminoxidil) N N NH2 N

NH2 Mirtazapine MM 1005.00 Mirtazapine (A) 100 mg

N N

N

MM 1005.02 Imp. A (EP): (14bRS)-2-Methyl-1,2,3,4,10- (A) 100 mg 14b-hexahydropyrazino[2,1-a]pyrido[2,3- O c][2]benzazepine 2-Oxide N N

N

MM 1005.03 Imp. B (EP): [2-[(2RS)-4-Methyl-2-phenyl- (A) 100 mg piperazin-1-yl]pyridin-3-yl]methanol N HO N

N

MM 1005.09 Imp. D (EP) as Maleate: (14bRS)-1,2,3,4,10,14b- (A) 50 mg O Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benz- NH OH azepine Maleate x N OH

N O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 157 Table of content Pharmaceutical impurities

Code Product Price Unit MM 1005.01 Imp. E (EP): (2RS)-4-Methyl-1-(3-methyl- (A) 100 mg pyridin-2-yl)-2-phenylpiperazine N N

N

MM 1005.07 1-Methyl-3-phenylpiperazine (A) 100 mg

N HN Moclobemide

MM 0250.00 Moclobemide O O (A) 100 mg N N H Cl Modafinil

MM 540.01 Imp. A (EP): [(RS)-(Diphenylmethyl)sulfinyl]acetic O O (A) 50 mg Acid S OH

MM 0540.02 Imp. B (EP): 2-[(Diphenylmethyl)sulfonyl]acetamide O O O (A) 50 mg S NH2

MM 0540.03 Imp. C (EP): Methyl [(RS)-(Diphenylmethyl)sulfinyl]- O O (A) 50 mg acetate S O

MM 0599.14 Bis(diphenylmethyl) Ether (A) 50 mg

O

MM 0540.04 2-[(Diphenylmethyl)sulfenyl]acetamide O (A) 50 mg S NH2

MM 540.06 Bis(diphenylmethyl)disulfide (A) 50 mg

S S

Molsidomine MM 0267.00 Molsidomine O (A) 250 mg O O N- N N+ N O MM 0267.02 Imp. A (EP) as Hydrochloride: 3-(Morpholin-4-yl)sydnonimine O N- (A) 100 mg HN N+ Hydrochloride (Linsidomine Hydrochloride) x HCl N O MM 0267.03 Imp. B (EP): 4-Nitrosomorpholine O (A) 100 mg N N O N MM 0267.01 Imp. C (EP): (2E)-(Morpholin-4-ylimino)acetonitrile N (A) 100 mg N O

MM 0267.06 Imp. E (EP): Morpholine HN (A) 100 mg O

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Code Product Price Unit Furoate New MM 1272.00 Mometasone Furoate Cl (A) 100 mg O O

HO O O Cl O Montelukast Sodium

MM 0698.00 Montelukast Sodium O 100 mg Cl N S ONa

HO

Morphine Hydrochloride MM 0037.00 Morphine Hydrochloride Trihydrate (A) 250 mg N [Controlled Substance] x HCl x 3 H2O

HO O OH MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: (A) 100 mg N Codeine Phosphate Hemihydrate x H3 PO4 [Controlled Substance] x ½ H2O

O O OH MM 0037.01 Imp. B (EP): 7,7',8,8'-Tetradehydro- -diepoxy- (A) 100 mg N 17,17'-dimethyl-2,2'-bimorphinanyl- -tetrol HO O OH (Pseudomorphine; 2,2'-Bimorphine)

HO O OH N

MM 0037.03 Imp. F (EP): (17S)-7,8-Didehydro- -epoxy-17- (A) 100 mg O N methylmorphinan- -diol17-Oxide (Morphine N-Oxide) [Controlled Substance]

HO O OH MM 0037.02 7,7',8,8'-Tetradehydro-4,5a:4',5'a-diepoxy-3,3'-dimethoxy- (A) 100 mg N 17,17'-dimethyl-2,2'-bimorphinanyl-6a,6'a-diol (Codeine HO O O Dimer; Dimethyl Pseudomorphine)

O O OH N

New MM 0037.09 Morphine Anhydrate (A) 100 mg N [Controlled Substance]

HO O OH Morphine Sulphate MM 0280.00 Morphine Hemisulphate Pentahemihydrate (A) 250 mg N [Controlled Substance] x H2SO4 x 5 H2O

O HO OH 2 MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: (A) 100 mg N Codeine Phosphate Hemihydrate x H3 PO4 [Controlled Substance] x ½ H2O

O O OH MM 0037.01 Imp. B (EP): 7,7',8,8'-Tetradehydro- -diepoxy- (A) 100 mg N 17,17'-dimethyl-2,2'-bimorphinanyl- -tetrol HO O OH (Pseudomorphine;2,2'-Bimorphine)

HO O OH N

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Code Product Price Unit MM 0037.03 (A) 100 mg Imp. F (EP): (17S)-7,8-Didehydro- -epoxy- O N 17-methylmorphinan- -diol 17-Oxide (Morphine N-Oxide) [Controlled Substance]

HO O OH Moxifloxacin Hydrochloride MM 0885.00 Moxifloxacine Hydrochloride H (D) 100 mg O HN N N H x HCl OH F O O Moxonidine MM 1278.02 Imp. B (EP): N-(Imidazolidin-2-ylidene)-4,6- (A) 100 mg N O dimethoxy-2-methylpyrimidin-5-amine HN (4-Methoxymoxonidine) N N N H O Mycophenolate Mofetil

MM 1001.00 Mycophenolate Mofetil O OH (D) 100 mg O N O O O O

MM 1001.05 Imp. E (EP): Methyl (4E)-6-(4-Hydroxy-6- O OH (A) 100 mg methoxy-7-methyl-3-oxo-1,3-dihydroiso- O O benzofuran-5-yl)-4-methylhex-4-enoate O O

MM 1001.06 Imp. F (EP): (4E)-6-(4-Hydroxy-6-methoxy-7- O OH (A) 100 mg methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)- OH 4-methylhex-4-enoic Acid (Mycophenolic Acid) O O O

OH MM 1001.07 Imp. G (EP): 2-(Morpholin-4-yl)ethyl O O (A) 100 mg O (4E)-6-(4-Hydroxy-6-methoxy-7-methyl- N O 3-oxo-1,3-dihydroisobenzofuran-5-yl)- O O 4-methylhex-4-enoate N-Oxide O

MM 1001.08 Imp. H (EP): 7-Hydroxy-5-methoxy-4-methyl- O OH (A) 100 mg 6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2- O O yl]ethyl]isobenzofuran-1(3H)-one O O

Nabumetone MM 0153.00 Nabumetone O (A) 500 mg

O MM 0153.02 Imp. A (EP): 3-(6-Methoxynaphthalen-2-yl)- O (A) 100 mg 5-methylcyclohexanone

O MM 0153.03 Imp. B (EP): (5RS)-5-(6-Methoxynaphthalen-2-yl)- O (A) 100 mg 3-methylcyclohex-2-enone

O MM 0153.04 Imp. C (EP): (2RS)-4-(6-Methoxynaphthalen-2-yl)- OH (A) 100 mg butan-2-ol

O MM 0153.05 Imp. D (EP): (E)-4-(6-Methoxynaphthalen-2-yl)- O (A) 100 mg but-3-en-2-one O MM 0153.06 Imp. E (EP): 1,5-Bis(6-methoxynaphthalen- O (A) 50 mg 2-yl)pentan-3-one

O O MM 0153.07 Imp. F (EP): 6,6'-Dimethoxy-2,2'-binaphthalenyl O (A) 100 mg

O

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Code Product Price Unit MM 0152.01 (6-Methoxy-2-naphthyl)acetic Acid ((6-Methoxynaphthalen- OH (A) 100 mg 2-yl)acetic Acid,  O O Nadolol MM 0439.00 Nadolol OH on request HO OH H O N

and enantiomers

MM 0439.06 Imp. F (EP) as Hydrochloride: (2RS)-1-[(1,1- OH (A) 50 mg H Dimethylethyl)amino]-3-(naphthalen-1-yloxy)- O N x HCl propan-2-ol Hydrochloride

MM 0439.07 Imp. G (EP) as Hydrochloride: (2RS)-1-[(1,1- OH (A) 50 mg H Dimethylethyl)amino]-3-[(5,6,7,8-tetrahydro- O N x HCl naphtalen-1-yl)oxy]-propan-2-ol Hydrochloride

Nafcillin Sodium O MM 0392.00 Nafcillin Sodium ONa on request O N O S NH H

O

HO MM 0392.02 Penilloic Acids of Nafcillin O (D) 100 mg O HN H N S O MM 0392.04 2-Ethoxynaphthoic Acid O OH (B) 100 mg O

Naftidrofuryl Hydrogen Oxalate

MM 0373.00 Naftidrofuryl Hydrogen Oxalate O (A) 500 mg N O OH O x O OH O Naloxone Hydrochloride Dihydrate MM 0272.00 Naloxone Hydrochloride Dihydrate (A) 250 mg N OH x HCl x 2 H2O

HO O O Naltrexone

MM 0233.00 Naltrexone Hydrochloride N (A) 100 mg

HO x HCl

HO O O MM 0660.00 Nandrolone OH (A) 250 mg H

O MM 0660.01 19-Norandrost-4-ene-3,17-dione (Estr-4-ene-3,17-dione) O (A) 100 mg

H

O

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Code Product Price Unit MM 0982.00 Nandrolone Decanoate O (A) 100 mg O

H

O MM 0660.00 Imp. D (EP): 17β-Hydroxyestr-4-en-3-one OH (A) 250 mg (Nandrolone) H

O Naphazoline Hydrochloride

MM 0075.00 Naphazoline Hydrochloride HN (A) 500 mg N x HCl

MM 0075.06 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)- O (A) 100 mg NH2 2-(naphthalen-1-yl)acetamide Hydrochloride N (Naphthylacetylethylenediamine Hydrochloride) H x HCl

MM 0075.02 Imp. B (EP): (Naphthalen-1-yl)acetic Acid O (B) 100 mg (1-Naphthylacetic Acid) OH

MM 0075.04 Imp. C (EP): (Naphthalen-1-yl)acetonitrile N (B) 100 mg (1-Naphthylacetonitrile)

New MM 0075.03 Imp. D (EP) as Hydrochloride: 2-(Naphthalen- (A) 50 mg HN N 2-ylmethyl)-4,5-dihydro-1H-imidazole -Naphazoline Hydrochloride) x HCl

MM 0075.05 Ethyl (1-Naphthyl)acetate O (A) 100 mg O

MM 0075.07 (Naphthalen-1-y)lacetamide (1-Naphthylacetamide) O (A) 100 mg NH 2

Naphazoline Nitrate

MM 0286.00 Naphazoline Nitrate HN (A) 500 mg N x HNO 3

MM 0075.06 Imp. A (EP) as Hydrochloride: O (A) 100 mg NH 2 N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide N Hydrochloride (Naphthylacetylethylenediamine H x HCl Hydrochloride)

MM 0075.02 Imp. B (EP): (Naphthalen-1-yl)acetic Acid O (B) 100 mg (1-Naphthylacetic Acid) OH

MM 0075.04 Imp. C (EP): (Naphthalen-1-yl)acetonitrile N (B) 100 mg (1-Naphthylacetonitrile)

MM 0075.05 Ethyl (1-Naphthyl)acetate O (A) 100 mg O

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Code Product Price Unit MM 0075.07 (Naphthalen-1-yl)acetamide O (A) 100 mg (1-Naphthylacetamide) NH2

Naproxen MM 0152.00 Naproxen (A) 500 mg OH O O MM 0152.06 Imp. A (EP): (2S)-2-(6-Hydroxynaphthalen-2-yl)- (A) 100 mg OH propanoic Acid (O-Demethylnaproxen) O HO MM 0152.09 Imp. B (EP): (2S)-2-(5-Chloro-6-methoxy- (A) 100 mg OH naphthalen-2-yl)propanoic Acid (5-Chloronaproxen) O O Cl MM 0152.10 Imp. C (EP): (2S)-2-(5-Bromo-6-methoxy- (A) 100 mg OH naphthalen-2-yl)propanoic Acid (5-Bromonaproxen) O O Br MM 0152.11 Imp. D (EP): (2S)-2-(5-Iodo-6-methoxy- (A) 100 mg OH naphthalen-2-yl)propanoic Acid (5-Iodonaproxen) O O I MM 0152.02 Imp. E (EP): Methyl (2S)-2-(6-Methoxy- (A) 100 mg O naphthalen-2-yl)propanoate (Naproxen Methyl Ester) O O MM 0152.12 Imp. F (EP): Ethyl (2S)-2-(6-Methoxy- (A) 100 mg O naphthalen-2-yl)propanoate (Naproxen Ethyl Ester) O O MM 0152.14 Imp. H (EP): 6-Methoxynaphthalen-2-ol OH (A) 100 mg (Hydroxynerolin) O MM 0152.01 Imp. I (EP):(6-Methoxynaphthalen-2-yl)acetic Acid OH (A) 100 mg -Demethylnaproxen) O O MM 0152.18 Imp. J (EP): 2-Ethyl-6-methoxynaphthalene (A) 100 mg (Ethylnerolin) O MM 0152.16 Imp. K (EP): (1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol OH (A) 100 mg

O MM 0152.07 Imp. L (EP): 1-(6-Methoxynaphthalen-2-yl)ethanone O (B) 100 mg (Acetylnerolin) O MM 0152.08 Imp. M (EP): 2-Methoxynaphthalene (Nerolin) (B) 100 mg

O MM 0152.17 Imp. N (EP): 2-Bromo-6-methoxynaphthalene Br (C) 100 mg O MM 0152.04 Naproxen Sodium (A) 500 mg ONa

O O MM 0152.15 2-Carboxy-6-methoxynaphthalene O (A) 100 mg OH O Nateglinide MM 0847.00 Nateglinide on request OH H N O O

MM 0847.03 Imp. B (Pharmeuropa): N-[[trans-4-(Propan- (A) 50 mg 2-yl)cyclohexyl]carbonyl]-L-phenylalanine O H N OH O

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Code Product Price Unit MM 0314.03 Imp. D Nateglinide (EP): Phenylalanine O (B) 100 mg H2N OH

MM 0847.04 Imp. E (Pharmeuropa): N-[(trans-4-Ethyl- (A) 50 mg cyclohexyl)carbonyl]-D-phenylalanine O H (Nateglinide Ethyl Analog) N OH O

MM 0847.09 Imp. F (EP) as Dicyclohexylammonium Salt: (A) 50 mg N-[[trans-4-(1-Methylethyl)cyclohexyl]carbonyl]- O D-phenylalanyl-D-phenylalanine Dicyclohexyl- H N OH ammonium Salt (Nateglinide IPP Impurity N H Dicyclohexylammonium Salt) O O

H N x

MM 0847.06 Imp. G (Pharmeuropa): Ethyl N-[[trans-4-(Propan- (A) 50 mg 2-yl)cyclohexyl]carbonyl]-D-phenylalaninate O H (Nateglinide Ethyl Ester) N O O

Nevirapine Anhydrous MM 1146.01 Imp. A (EP): 11-Ethyl-4-methyl-5,11-dihydro- (A) 100 mg 6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one N N N

NH O

MM 1146.02 Imp. B (EP): 4-Methyl-5,11-dihydro-6H- N H N (A) 100 mg N dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one NH O MM 1146.03 Imp. C (EP): 4-Methyl-11-propyl-5,11-dihydro- (D) 100 mg 6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one N N N

NH O MM 1146.04 3-Amino-2-chloro-4-methylpyridine Cl N (A) 100 mg

H2N

Nicardipine Hydrochloride MM 0465.00 Nicardipine Hydrochloride H (A) 250 mg N O O N x HCl O O

NO2 MM 0465.01 3-Methyl 5-[Methyl(phenylmethyl)amino]- N on request ethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine- O O 3,5-dicarboxylate Dihydrochloride N x 2 HCl O O

NO2 Nicergoline Br MM 0115.00 Nicergoline H (A) 100 mg N N O N O O

Cl MM 0115.02 Imp. A (EP): [(6aR,9R,10aS)-10a-Methoxy- H (D) 50 mg 4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N indolo[4,3-fg]quinolin-9-yl]methyl 5-Chloro- N O N pyridine-3-carboxylate (Chloronicergoline) O O

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Code Product Price Unit

MM 0115.04 Imp. C (EP): [(6aR,9R,10aS)-10a-Methoxy-4,7-dimethyl- H (D) 100 mg N 4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin- N 9-yl]methanol (Methylmethoxylumilysergol) OH O

MM 0115.06 Imp. D (EP): 5-Bromopyridine-3-carboxylic Acid Br (B) 100 mg

HO N

O MM 0115.03 5-Debromonicergoline H on request N N O N O O Nicorandil MM 0924.00 Nicorandil O (A) 100 mg O N NO 2 H N MM 0552.00 Nicotinamide O (A) 500 mg N NH2

MM 0552.01 Isonicotinamide O (A) 100 mg NH2 N Nicotine MM 0517.00 Nicotine (A) 500 mg N N

MM 0517.03 Imp. C (EP): (5S)-1-Methyl-5-(pyridin-3-yl)pyrrolidin-2-one (A) 100 mg (Cotinine) N N O

MM 0517.01 Imp. G (EP): 3-[(2S)-Piperidin-2-yl]pyridine (Anabasine) (A) 100 mg N N H

Nicotinic Acid MM 0553.00 Nicotinic Acid O (A) 500 mg N OH

MM 0553.06 Imp. B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic O (A) 100 mg Acid (6,6'-Dinicotinic Acid) N OH

HO N

O MM 0553.03 Imp. E (EP): Pyridine-4-carboxylic Acid O (A) 100 mg (Isonicotinic Acid) OH N MM 0549.00 Methyl Nicotinate O (A) 500 mg N O

MM 0104.00 Benzyl Nicotinate O (A) 500 mg N O

Nifedipine MM 0003.00 Nifedipine H (A) 500 mg N O O

O O NO2

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Code Product Price Unit MM 0003.02 Imp. A (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrophenylpyridine- N (A) 100 mg 3,5-dicarboxylate (Nitrophenylpyridine Analogue of Nifedipine) O O

O O NO2

MM 0003.01 Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrosophenylpyridine- N (A) 100 mg 3,5-dicarboxylate (Nitrosophenylpyridine Analogue of Nifedipine) O O

O O NO

MM 0003.07 Imp. C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2-Nitrobenzylidene)- O (A) 100 mg 3-oxobutanoate O

O NO2

MM 0003.08 Imp. D (EP): Methyl 3-Aminobut-2-enoate H2N (C) 100 mg O

O MM 0003.03 2-Nitrobenzaldehyde O (B) 100 mg NO 2

Niflumic Acid MM 0850.00 Niflumic Acid O (A) 250 mg OH

N NH

F F F MM 0915.01 Imp. A (EP): 2-Chloropyridine-3-carboxylic N Cl (A) 100 mg Acid (2-Chloronicotinic Acid) OH

O MM 0850.05 Imp. B (EP): 2-Hydroxy-N-[3-(trifluoro- N OH (A) 100 mg F F methyl)phenyl]pyridine-3-carboxamide H N F O MM 0161.06 Imp. C (EP): 3-(Trifluoromethyl)aniline F F (B) 100 mg F

NH2 MM 0850.01 Imp. F (EP): Methyl 2-[[3-(Trifluoromethyl)- F F (A) 100 mg phenyl]amino]pyridine-3-carboxylate F (Niflumic Acid Methyl Ester)

N NH

O

O Nifuroxazide MM 0574.00 Nifuroxazide OH (A) 500 mg H O O 2N N N O MM 0574.01 Imp. A (EP): 4-Hydroxybenzohydrazide OH (C) 100 mg H (p-Hydroxybenzohydrazide) N H2N O MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate OH (A) 500 mg (Methyl Parahydroxybenzoate) O

O MM 0943.02 Imp. C (EP): (5-Nitrofuran-2-yl)methylidene O (A) 100 mg Diacetate ((5-Nitrofuran-2-yl)methylene Diacetate) O O O2N O

O

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Code Product Price Unit Nifursol

MM 0444.00 Nifursol OH O (A) 100 mg NO2 O 2N N N O H

NO2

MM 0444.01 5-Nitro-2-furfural O (C) 100 mg O NO2

MM 0444.02 5-Nitrofurfural Hydrazone H2N N (A) 100 mg O NO2 MM 0444.03 3,5-Dinitrosalicylic Acid Hydrazide OH O (A) 100 mg O 2N NH2 N H

NO2 Nikethamide MM 0627.00 Nikethamide O (A) 500 mg N N

Nimesulide MM 0378.00 Nimesulide H (A) 250 mg N S O O O2 N O

MM 0378.01 Imp. A (EP): N-(2,4-Dinitro-6-phenoxyphenyl) NO2 H (A) 100 mg N methanesulphonamide S O O O 2N O

MM 0378.02 Imp. B (EP): N-(2-Phenoxyphenyl)methanesulphonamide H (A) 100 mg N S O O O

MM 0378.03 Imp. C (EP): 2-Phenoxyaniline NH 2 (A) 100 mg

O

MM 0378.04 Imp. D (EP): 4-Nitro-2-phenoxyaniline NH2 (A) 100 mg

O2N O

MM 0378.05 Imp. E (EP): N,N-Bis(methylsulphonyl)-2- O (A) 100 mg O S phenoxyaniline N S O O O

MM 0378.06 Imp. F (EP): N,N-Bis(methylsulphonyl)-4- O (A) 100 mg O S nitro-2-phenoxyaniline N S O O O O2 N

MM 0378.07 Imp. G (EP): 4-Nitro-2-phenoxyphenol OH (A) 50 mg

O 2N O

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Code Product Price Unit Nimodipine MM 0416.00 Nimodipine H (A) 100 mg N O O O O O

NO 2 MM 0416.01 Imp. A (EP): 2-Methoxyethyl 1-Methylethyl 2,6- N (A) 100 mg Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate O O O O O

NO 2 MM 0416.02 Imp. B (EP): Bis(1-methylethyl) 2,6-Dimethyl-4- H (A) 100 mg N (3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate O O O O

NO2 MM 0416.03 Imp. C (EP): Bis(2-methoxyethyl) 2,6-Dimethyl- H (A) 100 mg N 4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate O O O O O O

NO2 Nitrazepam MM 0078.00 Nitrazepam [Controlled Substance] H O (A) 100 mg N

O2N N

MM 0078.02 Imp. A (EP): 3-Amino-6-nitro-4-phenylquinolin-2(1H)-one H (A) 100 mg N O

O2N NH2

MM 0078.01 Imp. B (EP): (2-Amino-5-nitrophenyl)phenylmethanone NH2 (B) 100 mg (2-Amino-5-nitrobenzophenone) O O2N

O MM 0078.03 Imp. C (EP): 2-Bromo-N-[4-nitro-2-(phenyl- Br (A) 50 mg carbonyl)phenyl]acetamide NH

O O2 N

MM 0078.05 Imp. D (EP): 2-(1,3-Dioxo-1,3-dihydro-2H- O (A) 50 mg O isoindol-2-yl)-N-[4-nitro-2-(phenylcarbonyl)- N phenyl]acetamide NH O O O2 N

MM 0078.07 7-Aminonitrazepam H O (A) 100 mg N

H 2N N

Nitrendipine MM 0092.00 Nitrendipine H (A) 500 mg N O O O O

NO 2 MM 0092.03 Imp. A (EP): Ethyl Methyl 2,6-Dimethyl-4- N (A) 100 mg (3-nitrophenyl)pyridine-3,5-dicarboxylate (Photolysis Product) O O O O

NO 2

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Code Product Price Unit MM 0092.01 Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)- H (A) 100 mg N 1,4-dihydropyridine-3,5-dicarboxylate O O O O

NO 2 MM 0092.02 Imp. C (EP): Diethyl 2,6-Dimethyl-4-(3-nitrophenyl)- H (A) 100 mg N 1,4-dihydropyridine-3,5-dicarboxylate O O O O

NO2 MM 0092.04 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5- H (A) 50 mg N dicarboxylic Acid Methyl Ester O OH O O

NO2 MM 0092.05 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5- H (A) 50 mg N dicarboxylic Acid Ethyl Ester O OH O O

NO2 Nitrofural MM 0943.00 Nitrofural H (A) 500 mg O2N O N NH2 N O MM 0943.02 Imp. B (EP): (5-Nitrofuran-2-yl)methylene Diacetate O (A) 100 mg O O2 N O O

O Nitrofurantoin

H MM 0506.00 Nitrofurantoin O (A) 500 mg N O O O 2N N N

Nizatidine MM 0220.00 Nizatidine (A) 500 mg N NO2 N S S N N H H MM 0220.01 Imp. A (EP): N,N‘-Dimethyl-2-nitroethene-1,1-diamine NO2 (A) 100 mg

N N H H MM 0220.09 Imp. B (EP): (EZ)-N-Methyl-1-methylsulphanyl)-2- NO2 (A) 100 mg nitroethen-1-amine S N H MM 0220.02 Imp. C (EP): (EZ)-N-[2-[[[2-[(Dimethylamino)methyl]thiazol- (C) 50 mg N NO2 4-yl]methyl]sulphinyl]ethyl]-N‘-methyl-2-nitroethene- N O 1,1-diamine S S N N H H MM 0220.04 Imp. D (EP) as Dioxalate: 2-[[[2-[(Dimethyl- (A) 50 mg N HO O amino)methyl]thiazol-4-yl]methyl]sulphanyl]- N x2 ethanamine Dioxalate S S HO O NH2 MM 0220.10 Imp. G (EP): N,N'-Bis[2-[[[2-[(dimethylamino)- (A) 50 mg N N methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2- nitroethene-1,1-diamine NO2 N N S S S S N N H H MM 0220.11 Imp. H (EP) as Hydrochloride: 2-(Dimethylamino) S (A) 100 mg x HCl thioacetamide Hydrochloride N NH2 New MM 0220.06 Imp. I (EP): N-[2-[[[2-[(Dimethylamino)- (A) 50 mg N methyl]thiazol-4-yl]methyl]sulphanyl]- N O ethyl]-N'-methylurea S S N N H H

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Code Product Price Unit MM 0086.07 Imp. K (EP): 3-(Methylamino)-5,6-dihydro-2H- S N (A) 100 mg OH 1,4-thiazin-2-one Oxime N N H Nonivamide MM 1033.00 Nonivamide O (A) 500 mg O N H HO MM 1033.01 4-(Aminomethyl)-2-methoxyphenol Hydrochloride (Vanillylamine O (A) 100 mg NH 2 Hydrochloride) x HCl HO MM 1033.02 N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide O (A) 100 mg O (N-Vanillyloctanamide) N H HO MM 1033.03 N-[(4-Hydroxy-3-methoxyphenyl)methyl]- O (A) 100 mg O decanamide (N-Vanillyldecanamide) N H HO MM 1033.04 N,O-Dinonanoylvanillylamine O (A) 100 mg O N H O

O Noradrenaline Tartrate OH MM 0614.02 Imp. A (EP): Adrenaline (L-Adrenaline) H (A) 500 mg HO N

HO MM 0384.00 Imp. C (EP) as Hydrochloride: Dopamine Hydrochloride HO NH2 (A) 500 mg x HCl HO MM 0218.00 Norethisterone OH (A) 250 mg

O MM 0218.04 Imp. A (EP): 17-Hydroxy-19-nor- -pregna- OH (D) 100 mg 4,6-dien-20-yn-3-one (6,7-Didehydronorethisterone)

O MM 0660.01 Imp. B (EP): Estr-4-ene-3,17-dione (Norandrostenedione) O (A) 100 mg

O MM 0218.01 Imp. H -Dihydroxy-19-nor- -pregn- OH (D) 100 mg 4-en-20-yn-3-one (6β-Hydroxynorethisterone)

O OH MM 0218.02 -Hydroxynorethisterone OH (D) 50 mg

O OH MM 0218.03 6-Ketonorethisterone OH (D) 100 mg

O O MM 0219.00 Norethisterone Acetate O (A) 100 mg O

O

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Code Product Price Unit MM 0218.00 Imp. A (EP): Norethisterone OH (A) 250 mg

O MM 0219.10 Imp. B (EP): 3-Oxo-19-nor- -pregn-5(10)- O on request en-20-yn-17-yl Acetate O

O MM 0219.01 Imp. F -Hydroxy-3-oxo-19-nor- - O (D) 100 mg pregn-4-en-20-yn-17-yl Acetate O -Hydroxynorethisterone Acetate)

O OH MM 0219.03 Imp. G (EP): 3,6-Dioxo-19-nor- -pregn- O (D) 100 mg 4-en-20-yn-17-yl Acetate O (6-Ketonorethisterone Acetate)

O O MM 0219.02 6-Hydroxynorethisterone Acetate O (D) 50 mg O

O OH MM 0219.04 6,7-Didehydronorethisterone Acetate O (D) 100 mg O

O Norfenefrine Hydrochloride MM 0973.00 Norfenefrine Hydrochloride OH (A) 500 mg HO NH 2 x HCl

Norfloxacin

MM 0350.00 Norfloxacin HN (A) 250 mg N N OH F O O MM 0350.01 Imp. A (EP): 7-Chloro-1-ethyl-6-fluoro-4-oxo- (A) 100 mg 1,4-dihydroquinoline-3-carboxylic Acid Cl N

OH F O O

MM 0350.03 Imp. D (EP): 1-Ethyl-6-fluoro-7-(piperazin-1-yl) HN (D) 100 mg quinolin-4(1H)-one N N

F O

MM 0350.04 Imp. G (EP): 1-Ethyl-6-fluoro-7-(4-formyl-piperazin-1-yl)- O N (D) 100 mg 4-oxo-1,4-dihydroquinoline-3-carboxylic Acid N N OH F O O Nortriptyline Hydrochloride MM 0079.00 Nortriptyline Hydrochloride (A) 500 mg x HCl N H MM 0062.01 Imp. A (EP): 10,11-Dihydro-5H-dibenzo[a,d][7] (B) 100 mg annulen-5-one (Dibenzosuberone) O MM 0079.01 Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo- (A) 50 mg [a,d][7]annulen-5-ylidene)-N-methylpropan-1- amine Hydrochloride (Norcyclobenzaprine N x HCl H Hydrochloride)

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Code Product Price Unit MM 0062.03 Imp. D (EP): 5-[3-(Dimethyl-amino)propyl]- (A) 100 mg N 10,11-dihydro-5H-dibenzo-[a,d][7]annulen-5-ol OH

MM 0062.02 Imp. E (EP) as Hydrochloride: 3-(5H- (A) 100 mg Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethyl- propan-1-amine Hydrochloride (Cyclobenzaprine N x HCl Hydrochloride)

MM 0062.00 Imp. F (EP) as Hydrochloride: (A) 500 mg Amitriptyline Hydrochloride N x HCl

MM 0062.12 Imp. J (EP) as Hydrochloride: [3-(10,11- (B) 10 mg Dihydro-5H-dibenzo[a,d][7]annulen- O 5-ylidene)propyl]-dimethylamine Oxide Hydrochloride N x HCl (Amitriptyline N-Oxide Hydrochloride)

Nucleosides MM 1316.01 Cytidine NH2 (A) 100 mg N

HO O N O

OH OH MM 1316.02 2'-Deoxycytidine NH2 (A) 100 mg N

HO O N O

OH Ofloxacin

MM 0228.00 Ofloxacin N O (A) 500 mg N N OH F O O

MM 0228.04 Imp. A (EP): (RS)-9,10-Difluoro-3-methyl-7-oxo- O (A) 100 mg 2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6- F N carboxylic Acid (FPA) OH F O O MM 0228.05 Imp. B (EP): (RS)-9-Fluoro-3-methyl-10-(4- N O (A) 100 mg methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido- N N [1,2,3-de]-1,4-benzoxazin-7-one F O MM 0228.08 Imp. E (EP): (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin- HN O (A) 100 mg 1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine- N N 6-carboxylic Acid OH F O O MM 0228.10 Imp. F (EP) as Hydrochloride: 4-[(RS)-6-Carboxy- N O (A) 100 mg O 9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H- N N pyrido[1,2,3-de]-1,4-benzoxazine-10-yl]- x HCl OH 1-methylpiperazine 1-Oxide Hydrochloride F (Ofloxacin N-Oxide Hydrochloride) O O

Olanzapine

MM 0329.00 Olanzapine N on request N N

HN S

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Code Product Price Unit MM 0329.08 Imp. A (EP): 5-Methyl-2-[(2-nitrophenyl)- N (A) 50 mg amino]thiophene-3-carbonitrile HN O2 N S

MM 0329.02 Imp. B (EP): 2-Methyl-5,10-dihydro-4H- H (A) 50 mg N O thieno[2,3-b][1,5]benzodiazepin-4-one (Olanzapine Lactame) HN S MM 0329.07 Imp. C (EP): 1-(Chloromethyl)-1-methyl-4-(2- Cl (A) 100 mg N+ methyl-10H-thieno[2,3-b][1,5]benzodiazepin- N 4-yl)piperazin-1-ium Chloride N Cl- (Olanzapine-N-Chloromethyl Chloride) HN S MM 0329.03 Imp. D (EP): 1-Methyl-4-(2-methyl-10H-thieno- O (A) 50 mg [2,3-b][1,5]benzodiazepin-4-yl)piperazin-1-oxide N (Olanzapine N-Oxide) N N

HN S Omeprazole MM 0095.00 Omeprazole O (A) 500 mg H N S N O N O MM 0095.03 Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol H (A) 100 mg N SH O N MM 0095.04 Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin (A) 100 mg -2-yl)methyl]sulphinyl]-5-methoxy-1H- H N benzimidazole S N O O N MM 0095.06 Imp. C (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin- O (A) 100 mg 2-yl)methyl]sulphanyl]-1H-benzimidazole (Ufiprazole) H N S N O N MM 0095.05 Imp. D (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin- O (A) 100 mg 2-yl) methyl]sulphonyl]-1H-benzimidazole (Omeprazole H N Sulphone) SN O O N O MM 0095.07 Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1H- (A) 100 mg O benzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine NH O 1-Oxide (Omeprazole N-Oxide) N S O N O MM 0095.01 Imp. F (EP): 8-Methoxy-1,3-dimethyl- S (D) 50 mg 12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol- N O 2(12H)-one O N N

MM 0095.02 Imp. G (EP): 9-Methoxy-1,3-dimethyl- O S (D) 50 mg 12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol- N 2(12H)-one O N N MM 0095.15 Imp. H (EP): 2-[(RS)-[(4-Chloro-3,5-dimethylpyridin- (D) 100 mg O 2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole NH Cl N S O N MM 0095.16 Imp. I (EP): 4-Methoxy-2-[[(5-methoxy-1H-benzimidazol- (A) 100 mg O 2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide NH O (Omeprazole Sulphone N-Oxide) N S O O N O MM 0095.08 5-Methoxy-2-[[(3,5-dimethylpyridin-2-yl)methyl] (A) 100 mg O sulphanyl]-1H-benzimidazole NH N S N MM 0095.19 5-Methoxy-2-[[(4-chloro-3,5-dimethylpyridin-2-yl) (D) 100 mg O methyl]sulphanyl]-1H-benzimidazole NH Cl N S N

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Code Product Price Unit MM 0095.20 5-Methoxy-1,3-dihydrobenzimidazol-2-one (A) 100 mg O NH

N O H MM 0095.23 2-[[(4-Methoxy-3,5-dimethylpyridin-2-yl)methyl] (A) 100 mg sulphinyl]-1H-benzimidazole NH O N S O N MM 0095.24 5-Methoxy-2-(4-methoxy-3,5-dimethylpyridin-2-yl)-1H- (A) 100 mg O benzimidazole NH O N N Ondansetron Hydrochloride Dihydrate MM 0252.00 Ondansetron Hydrochloride Dihydrate (A) 100 mg N N x HCl N x 2 H2 O O MM 0252.09 Ondansetron (A) 100 mg N N N O MM 0252.03 Imp. A (EP): (3RS)-3-(Dimethylamino)methyl- (A) 100 mg N 9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one N O MM 0252.02 Imp. B (EP): 6,6'-Methylene bis[(3RS)- (D) 50 mg N N 9-methyl-3-[(2-methyl-1H-imidazol- 1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol- 4-one] N N N O O N

MM 0252.01 Imp. C (EP): 9-Methyl-1,2,3,9-tetrahydro-4H- (A) 100 mg N carbazol-4-one

O MM 0252.04 Imp. D (EP): 9-Methyl-3-methylene-1,2,3,9- (A) 100 mg N tetrahydro-4H-carbazol-4-one

O MM 0015.02 Imp. E (EP): 1H-Imidazole (Imidazole) N (B) 100 mg N H MM 0252.06 Imp. F (EP): 2-Methyl-1H-imidazole N (B) 100 mg N H MM 0252.07 Imp. G (EP): (3RS)-3-[(1H-Imidazol-1-yl)methyl]-9- (A) 100 mg N N methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one (C-Demethylondansetron) N O MM 0252.08 Imp. H (EP): (3RS)-3-[(2-Methyl-1H-imidazol-1-yl) H (A) 100 mg N N methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (N-Demethylondansetron) N O Opipramol Dihydrochloride MM 0422.01 5-(3-Piperazin-1-yl-propyl)-5H-dibenzo[b,f]azepine (A) 100 mg Dihydrochloride N x 2 HCl

N NH Ornidazole MM 0948.00 Ornidazole O2 N (A) 500 mg N Cl OH N MM 0012.02 2-Methyl-4-nitroimidazole O2 N (B) 100 mg NH N MM 0948.02 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)propane-1,2-diol O2 N (A) 100 mg N OH OH N

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Code Product Price Unit MM 0948.03 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)-1,2-epoxypropane O2 N (A) 100 mg N O N

MM 0948.04 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole N Cl (A) 100 mg O2 N OH N Orphenadrine Hydrochloride MM 0801.00 Orphenadrine Hydrochloride (A) 500 mg

x HCl N O

MM 0801.01 Imp. A (EP): (RS)-(2-Methylphenyl)phenylmethanol (A) 100 mg (2-Methylbenzhydrol)

OH

MM 0801.02 Imp. B (EP): (2-Methylphenyl)phenylmethanone (A) 100 mg (2-Methylbenzophenone)

O

MM 0801.03 Imp. C (EP) as Hydrochloride: (RS)-2-[(2-Methyl- (A) 50 mg phenyl)phenylmethoxy]ethanamine Hydrochloride x HCl NH2 O

MM 0490.00 Imp. D (EP) as Hydrochloride: Diphenhydramine (A) 500 mg Hydrochloride x HCl N O

MM 0801.05 Imp. E (EP) as Hydrochloride: (RS)-N,N-Dimethyl- (A) 100 mg 2-[(3-methylphenyl)phenylmethoxy]ethanamine Hydrochloride (meta-Methylbenzyl Isomer Hydrochloride) N x HCl O

MM 0490.04 Imp. F (EP) as Hydrochloride: (RS)-N,N-Dimethyl- (A) 100 mg 2-[(4-methylphenyl)phenylmethoxy]ethanamine Hydrochloride (para-Methylbenzyl Isomer Hydro- x HCl N chloride; 4-Methyldiphenhydramine Hydrochloride) O

MM 0801.07 N-Desmethylorphenadrine Hydrochloride (A) 100 mg

H x HCl N O

Oxacillin Sodium O MM 0686.00 Oxacillin Sodium Monohydrate ONa (A) 250 mg O O N x H 2O N N S H H O

O MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- OH (B) 100 mg 7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- O carboxylic Acid (6-Aminopenicillanic Acid) N S H2N H

MM 0682.00 Imp. E (EP) as Sodium Salt Monohydrate: Cl O (A) 500 mg Cloxacillin Sodium Monohydrate ONa O N N H x H2O O N S H O Oxalic Acid Dihydrate MM 0928.00 Oxalic Acid Dihydrate O OH (A) 500 mg x 2 H2O O OH

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Code Product Price Unit MM 0928.01 Oxalic Acid O OH (A) 500 mg

O OH Oxaliplatin MM 0928.00 Imp. A (EP) as Dihydrate: Ethanedioic Acid O OH (A) 500 mg Dihydrate (Oxalic Acid Dihydrate) x 2 H2O O OH Oxazepam MM 0080.00 Oxazepam [Controlled Substance] H O (D) 100 mg N OH Cl N

MM 0028.03 Imp. D (EP): (2-Amino-5-chlorophenyl)phenylmethanone NH2 (B) 100 mg (2-Amino-5-chlorobenzophenone) O Cl

MM 0028.02 Imp. E (EP): 7-Chloro-5-phenyl-1,3-dihydro- H O (A) 100 mg N 2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam) Cl N O

MM 0080.03 6-Chloro-4-phenyl-3,4-dihydroquinazoline-2- O (A) 100 mg N carboxylic Acid OH NH Cl

Oxcarbazepine MM 0076.17 Oxcarbazepine O (A) 100 mg

N O NH2 MM 0076.10 10-Hydroxy-10,11-dihydrocarbamazepine HO (A) 100 mg

N O NH2 Oxeladin Hydrogen Citrate MM 0547.00 Oxeladin Hydrogen Citrate O (A) 500 mg OH O O O O N x OH OH OH O O MM 0547.02 Imp. A (EP): 2-[2-(Diethylamino)ethoxy]ethanol HO N (A) 100 mg

MM 0547.01 Oxeladin N-Oxide O (B) 10 mg O O N O

Oxfendazole

O MM 0518.02 Imp. B (EP): Methyl [5-(Phenylsulphonyl)- H (A) 100 mg 1H-benzimidazol-2-yl]carbamate N O NH (Fenbendazole Sulphone) S N O O Oxiracetam New MM 1406.00 Oxiracetam HO (A) 250 mg O N NH2 O

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Code Product Price Unit Oxolinic Acid MM 0898.00 Oxolinic Acid (A) 250 mg O N

OH O O O Oxomemazine MM 0957.00 Oxomemazine (A) 100 mg N

N

S O O MM 0958.00 Trimeprazine Tartrate (A) 500 mg N OH O x HO N OH O OH S 2 MM 0958.02 Trimeprazine Sulphoxide Hydrochloride (A) 100 mg N

N x HCl

S O MM 0958.04 Oxomemazine N-Oxide Hydrochloride O (A) 100 mg N (Trimeprazine Sulphone N-Oxide Hydrochloride) N x HCl

S O O Oxprenolol Hydrochloride

MM 0129.00 Oxprenolol Hydrochloride OH H (A) 500 mg O N x HCl O OH MM 0129.01 1-(2-Hydroxyphenoxy)-3-(isopropylamino)-2-propanol H (A) 50 mg O N Hydrochloride x HCl

OH Oxybuprocaine Hydrochloride

MM 0543.00 Oxybuprocaine Hydrochloride O (A) 500 mg N O x HCl H2N O MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid O (B) 100 mg OH

H2 N MM 0543.02 Imp. B (EP): 4-Amino-3-butoxybenzoic Acid O (A) 100 mg OH

H2N O MM 0543.03 Imp. C (EP): 4-Amino-3-hydroxybenzoic Acid O (A) 100 mg OH

H2N OH

MM 0543.05 Oxybuprocaine N-Oxide Dihydrochloride O (A) 100 mg N O O x 2 HCl H2N O Oxybutynin Hydrochloride

MM 0047.00 Oxybutynin Hydrochloride O (A) 250 mg

O x HCl N OH

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Code Product Price Unit MM 0047.06 Imp. B (EP): 4-(Diethylamino)but-2-ynyl (A) 100 mg 2-Hydroxy-2,2-diphenylacetate HO N (Diphenyl analogue of Oxybutynin) O O MM 0047.04 Imp. C (EP) as Hydrochloride: 4-(Ethylmethylamino)but- (D) 100 mg 2-ynyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate HO N Hydrochloride (Methylethyl analogue of Oxybutynin O x HCl Hydrochloride) O

MM 0047.01 Imp. D (EP): (RS)-2-Cyclohexyl-2-hydroxy- (A) 100 mg 2-phenylacetic Acid (Phenylcyclohexylglycolic Acid) HO OH O MM 0047.07 Imp. E (EP): 4-(Ethylpropylamino)but-2-ynyl (RS)- (A) 100 mg 2-Cyclohexyl-2-hydroxy-2-phenylacetate HO N (Ethylpropyl analogue of Oxybutynin) O O

MM 0047.02 Methyl (RS)-2-Cyclohexyl-2-hydroxy-2- O (A) 100 mg phenylacetate (Phenylcyclohexylglycolic O Acid Methyl Ester) OH

MM 0047.03 4-Diethylaminobut-2-yn-1-ol N (A) 100 mg HO

MM 0047.11 Desethyloxybutynin Hydrochloride (D) 100 mg HO N x HCl O H O MM 0047.50 Propargyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate (B) 10 mg (Phenylcyclohexylglycolic Acid Propargyl Ester) HO O O Oxycodone Hydrochloride

MM 0672.00 Oxycodone Hydrochloride N (A) 100 mg [Controlled Substance] HO x HCl

O O O New MM 0672.10 Oxycodone N (A) 100 mg [Controlled Substance] HO

O O O MM 0672.03 Imp. C -Epoxy-14- H (D) 50 mg N hydroxy-3-methoxymorphinan-6-one Hydrochloride HO (Noroxycodone Hydrochloride) x HCl

O O O MM 0672.05 4 -Epoxy-3-methoxy-17-methylmorphinan- N on request -diol Hydrochloride HO x HCl

O O OH O MM 0672.06 Oxycodone N-Oxide N (D) 50 mg

HO

O O O Oxymetazoline Hydrochloride MM 0177.00 Oxymetazoline Hydrochloride (A) 250 mg HO N x HCl HN

MM 0177.01 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)- H (A) 100 mg HO N 2-[4-(1,1-dimethylethyl)-3-hydroxy- NH2 x HCl 2,6-dimethylphenyl)]acetamide Hydrochloride O

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Code Product Price Unit MM 0089.00 Imp. B (EP) as Hydrochloride: (A) 500 mg Xylometazoline Hydrochloride N x HCl N H MM 0177.07 Imp. C (EP): 2-[4-(1,1-Dimethylethyl)-3- OH (A) 100 mg hydroxy-2,6-dimethylphenyl]acetamide O

NH2

MM 0177.04 Imp. D (EP): [4-(1,1-Dimethylethyl)-3- OH (A) 100 mg hydroxy-2,6-dimethylphenyl]acetic Acid O

OH

MM 0177.05 Imp. E (EP): [4-(1,1-Dimethylethyl)-3- OH (D) 100 mg hydroxy-2,6-dimethylphenyl]acetonitrile N

Oxymorphone Hydrochloride Monohydrate

New MM 0673.00 Oxymorphone Hydrochloride Monohydrate N (A) 100 mg [Controlled Substance] HO x HC x H2O

HO O O New MM 0673.03 Noroxymorphone Hydrochloride H (A) 100 mg N

HO x HCl

HO O O Oxyphenbutazone MM 0933.00 Oxyphenbutazone Monohydrate OH (A) 250 mg O N x H2O N O

Oxytetracycline Hydrochloride MM 0554.00 Oxytetracycline Hydrochloride OH O OH O O (A) 500 mg OH NH2 H H x HCl OH HO OH N

MM 0452.00 Imp. B (EP) as Hydrochloride: OH O OH O O (A) 500 mg OH Tetracycline Hydrochloride NH2 H H x HCl OH HO N Pantoprazole Sodium Sesquihydrate MM 0099.00 Pantoprazole Sodium (D) 100 mg O NNa O F O F N S O N MM 0099.01 Pantoprazole (D) 100 mg O NH O F O F N S O N MM 0099.02 Imp. A (EP): 5-(Difluoromethoxy)-2-[[(3,4- (A) 100 mg O dimethoxypyridin-2-yl)methyl]sulphonyl]- NH F O 1H-benzimidazole (Pantoprazole Sulphone) F N S O O O

N MM 0099.03 Imp. B (EP): 5-(Difluoromethoxy)-2-[[(3,4- (A) 100 mg O NH O dimethoxypyridin-2-yl)methyl]sulphanyl]- F O 1H-benzimidazole F N S N MM 0099.04 Imp. C (EP): 5-(Difluoromethoxy)-1H- (A) 100 mg O NH benzimidazole-2-thiol F F N SH

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Code Product Price Unit MM 0099.11 Mixture of Imp. D and F (EP): 5- and 6-(Di- (D) 100 mg O N O fluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin- F O 2-yl)methyl]sulphinyl]-1-methyl-1H-benzimidazole F N S O N F + O F N O O N S O N MM 0099.05 2-Chloromethyl-3,4-dimethoxypyridine Hydrochloride (A) 100 mg O O Cl x HCl N MM 0099.06 Pantoprazole N-Oxide (D) 100 mg O NH O F O F N S O N O MM 0099.07 Pantoprazole Sulphone N-Oxide (A) 100 mg O NH O F O F N S O O N O Paracetamol MM 0042.00 Paracetamol H (A) 500 mg N O HO

MM 0042.08 Imp. A (EP): N-(2-Hydroxyphenyl)acetamide OH H (B) 100 mg (2-Acetamidophenol) N O MM 0042.05 Imp. B (EP): N-(4-Hydroxyphenyl)propanamide H (A) 100 mg N (N-Propionyl-4-aminophenol) O HO MM 0042.09 Imp. C (EP): N-(3-Chloro-4-hydroxyphenyl)acetamide H (A) 100 mg Cl N (3-Chloro-4-hydroxyacetanilide) O HO MM 0042.10 Imp. D (EP): N-Phenylacetamide (Acetanilide) H (B) 100 mg N O MM 0042.11 Imp. E (EP): 1-(4-Hydroxyphenyl)ethanone O (B) 100 mg (4-Hydroxyacetophenone) HO MM 0042.03 Imp. F (EP): 4-Nitrophenol NO 2 (B) 100 mg

HO HO MM 0042.12 Imp. G (EP): 1-(4-Hydroxyphenyl)ethanone Oxime N (A) 100 mg (4-Hydroxyacetophenone Oxime)

HO MM 0042.04 Imp. H (EP): 4-(Acetylamino)phenyl Acetate H (A) 100 mg N (N,O-Diacetyl-4-aminophenol) O O O MM 0042.13 Imp. I (EP): 1-(2-Hydroxyphenyl)ethanone O (B) 100 mg (2-Hydroxyacetophenone) OH MM 0042.02 Imp. J (EP): N-(4-Chlorophenyl)acetamide H (B) 100 mg N (4-Chloroacetanilide) O Cl MM 0042.01 Imp. K (EP): 4-Aminophenol NH2 (B) 100 mg HO MM 0042.07 3-Aminophenol HO NH2 (B) 100 mg

Paroxetine Hydrochloride Anhydrous New MM 1032.01 Imp. A (EP) as Hydrochloride: (3S,4R)-3-[(1,3- (A) 50 mg Benzodioxol-5-yloxy)methyl]-4-phenylpiperidine Hydrochloride (Desfluoroparoxetine Hydro- x HCl chloride) O O NH O

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Code Product Price Unit MM 1032.02 Imp. B (EP): 1,3-Benzodioxol-5-ol (Sesamol) O OH (A) 100 mg

O MM 1032.07 Imp. G (EP) as Hydrochloride: 4-(4-Fluorophenyl)- F (A) 100 mg 1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride x HCl N MM 1032.12 [(3S,4R)-4-(4-Fluorophenyl)-1-methylpiperidin-3-yl] F (A) 100 mg methanol

HO N Paroxetine Hydrochloride Hemihydrate New MM 0264.00 Paroxetine Hydrochloride Hemihydrate F (A) 100 mg

x HCl x 1/2 H2O O O NH

O Pentetrazol

MM 0692.00 Pentetrazol N (A) 500 mg N N N Pentobarbital New MM 1357.00 Pentobarbital [Controlled Substance] H (A) 100 mg O N O NH

O Pentobarbital Sodium New MM 1368.00 Pentobarbital Sodium [Controlled Substance] H (A) 100 mg O N ONa N

O Pentoxifylline MM 0761.00 Pentoxifylline O O (A) 500 mg N N

O N N

MM 0577.00 Imp. A (EP): Theobromine O (A) 500 mg N HN

O N N

MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine- O (A) 100 mg H 2,6-dione (3-Methylxanthine) HN N

O N N

MM 0176.00 Imp. C (EP): Theophylline O (A) 500 mg H N N

O N N

MM 0494.00 Imp. F (EP): Caffeine O (A) 500 mg N N

O N N

Pentoxyverine Hydrogen Citrate

MM 1268.01 Imp. A (EP): 1-Phenylcyclopentanecarboxylic Acid O (A) 100 mg OH

Peppermint Oil MM 0388.00 (-)-Menthol (Levomenthol) (A) 500 mg

OH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 181 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0163.12 (+)-(R)-Pulegone (A) 100 mg

O

Perazine Dimaleate

MM 0815.00 Perazine Dimaleate N O (A) 100 mg N HO x 2 N HO

O S Perazine Dimalonate

MM 0157.00 Perazine Dimalonate N on request N O OH N x2 O S HO

MM 0157.01 Perazine Sulphoxide N (A) 100 mg N N

S O MM 0157.02 Phenothiazine H (B) 100 mg N

S

MM 0157.03 1-(3-Chloropropyl)-4-methylpiperazine N on request Cl N Perphenazine MM 0826.00 Perphenazine (A) 100 mg

N N S N OH

Cl MM 0826.01 Imp. A (EP): 2-[4-[3-(2-Chloro-5-oxido-10H- (A) 100 mg phenothiazin-10-yl)propyl]piperazin-1-yl]- ethanol (Perphenazine Sulphoxide) N N S N O OH

Cl MM 0826.02 Imp. B (EP): 2-[4-[3-(10H-Phenothiazin-10- (A) 50 mg yl)propyl]piperazin-1-yl]ethanol N N S N OH

Pethidine Hydrochloride

New MM 0315.00 Pethidine Hydrochloride [Controlled Substance] N (A) 100 mg x HCl

O O New MM 0315.13 Prepethidine [Controlled Substance] N (A) 100 mg

N New MM 0315.04 Imp. D (EP): Methyl 1-Methyl-4-phenyl- N (A) 100 mg piperidine-4-carboxylate [Controlled Substance] O O New MM 0315.05 Imp. E (EP): Ethyl 4-Phenylpiperidine-4- NH (A) 100 mg carboxylate [Controlled Substance]

O O Phenazepam New MM 0828.00 Phenazepam H O (A) 100 mg N

Br N

Cl

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Code Product Price Unit Phenacetin MM 0551.00 Phenacetin H (A) 100 mg N O O MM 0042.00 Paracetamol H (A) 500 mg N O HO MM 0042.01 4-Aminophenol NH2 (B) 100 mg

HO Phenethyl Alcohol MM 0953.00 Phenylethyl Alcohol OH (A) 500 mg

Pheniramine Maleate

MM 0059.00 Pheniramine Maleate N O (A) 100 mg N OH x OH

O

MM 0059.02 Imp. A (EP): 2-Benzylpyridine N (C) 100 mg

MM 0059.03 Imp. B (EP): 4-Benzylpyridine N (C) 100 mg

MM 0059.09 Imp. C (EP) as Sesquifumarate: (3RS)-N,N- N O (A) 100 mg Dimethyl-3-phenyl-3-(pyridin-4-yl)propan- N OH 1-amine Sesquifumarate x 1,5 HO

O MM 0059.08 Imp. D (EP) as Dihydrochloride: N,N,N',N'- (D) 100 mg N Tetramethyl-3-phenyl-3-(pyridin-2-yl)pentane- N 1,5-diamine Dihydrochloride x 2 HCl N

MM 0059.01 Pheniramine N (A) 100 mg N

MM 0059.05 Pheniramine N-Oxide Dihydrochloride N (A) 100 mg O N x 2 HCl

MM 0059.06 Norpheniramine Maleate N O (A) 100 mg H N OH x OH

O Phentolamine Mesilate MM 0171.04 Imp. B (EP) as Hydrochloride: 2-(Chloromethyl)- N (A) 100 mg x HCl 4,5-dihydro-1H-imidazole Hydrochloride N H Cl Phenobarbital MM 0265.07 Imp. B (EP): (5RS)-5-Ethyl-6-imino-5- H (A) 50 mg HN N O phenyldihydropyrimidine-2,4(1H,3H)- dione NH O

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Code Product Price Unit MM 0265.08 Imp. C (EP): 5-Methyl-5-phenylpyrimidine- H (A) 50 mg O N O 2,4,6(1H,3H,5H)-trione NH

O

MM 0265.01 Phenylethylacetylurea O O (A) 100 mg (2-Phenylbutyrylurea) N NH2 H

MM 0265.02 N-Benzoyl-N'-(2-phenyl)butanoylurea O O O (A) 100 mg N N H H

MM 0265.03 Barbituric Acid H (C) 100 mg O N O NH

O Phenoxyethanol O MM 0952.00 Phenoxyethanol OH (A) 500 mg

Phenoxymethylpenicillin Potassium

O MM 0026.00 Phenoxymethylpenicillin Potassium OK (A) 250 mg O N H N O S H O MM 0160.00 O (A) 250 mg Imp. A (EP) as Potassium Salt: Benzylpenicillin OK Potassium O N H N S H O MM 0026.03 Imp. B (EP): Phenoxyacetic Acid (B) 100 mg OH O O O MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- OH (B) 100 mg 7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O (6-Aminopenicillanic Acid) N S H 2N H MM 0026.02 Imp. D (EP): (2S,5R,6R)-3,3-Dimethyl-7-oxo- O (A) 100 mg OH 6-[[2-(4-hydroxyphenoxy)acetyl]amino]-4-thia- HO O 1-azabicyclo[3.2.0]heptane-2-carboxylic Acid N H (4-Hydroxyphenoxymethylpenicillin) N S O H O MM 0026.01 Imp. E (EP): (4S)-2-[Carboxy[(phenoxyacetyl) O (A) 100 mg OH amino]methyl]-5,5-dimethylthiazolidine-4- carboxylic Acid HN H (Penicilloic Acids of Phenoxymethylpenicillin) N S O O O OH MM 0026.05 Imp. F (EP): (2RS,4S)-5,5-Dimethyl-2- O (A) 100 mg OH [[(phenoxyacetyl)amino]methyl]thiazolidine- HN 4-carboxylic Acid (Penilloic Acids of Phenoxymethylpenicillin) S NH O O Phenylbutazone MM 0548.00 Phenylbutazone (A) 500 mg O N N O

MM 0548.01 Imp. A (EP): (2RS)-2-[(1,2-Diphenyldiazanyl)- O (D) 100 mg carbonyl]hexanoic Acid N NH O OH

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Code Product Price Unit MM 0548.02 Imp. B (EP): 4-Butyl-4-hydroxy-1,2- (A) 50 mg O diphenylpyrazolidine-3,5-dione N N OH O

MM 0548.03 Imp. C (EP): 1,2-Diphenyldiazane (A) 100 mg H (1,2-Diphenylhydrazine) N N H

MM 0548.04 Imp. D (EP): 1,2-Diphenyldiazene (C) 100 mg N N

MM 0548.05 Imp. E (EP) as Dihydrochloride: Biphenyl-4,4'- (A) 100 mg H2N NH2 x 2 HCl diamine Dihydrochloride (Benzidine Dihydrochloride) Phenylephrine Hydrochloride

OH MM 0081.00 Phenylephrine Hydrochloride H (A) 500 mg HO N x HCl

O MM 0081.03 Imp. C (EP) as Hydrochloride: 1-(3-Hydroxyphenyl)- H (D) 100 mg HO N 2-(methylamino)ethanone Hydrochloride x HCl (Phenylephrone Hydrochloride)

MM 0081.08 Imp. E (EP) as Hydrochloride: 2-(Benzyl- O (D) 100 mg HO N methylamino)-1-(3-hydroxyphenyl)ethanone x HCl Hydrochloride (Benzylphenylephrone Hydrochloride)

MM 0081.05 1,2,3,4-Tetrahydro-4,6-dihydroxy-2- OH (A) 100 mg HO methylisoquinoline Hydrochloride x HCl N

MM 0081.06 1,2,3,4-Tetrahydro-4,8-dihydroxy-2- OH (A) 50 mg methylisoquinoline Hydrochloride x HCl N OH Phenylpropanolamine Hydrochloride MM 0656.00 Phenylpropanolamine Hydrochloride [Drug Precursor] OH (A) 500 mg NH2 x HCl

and enatiomere Phenyltoloxamine Citrate MM 0770.00 Phenyltoloxamine Citrate O (A) 500 mg OH N O OH x O OH OH O MM 0630.00 Phenytoin (A) 500 mg H N O NH O

MM 0630.01 Imp. A (EP): Diphenylmethanone (Benzophenone) (B) 100 mg

O

MM 0630.02 Imp. B (EP): Diphenylethanedione (Benzil) O (B) 100 mg

O MM 0630.04 Imp. C (EP): Amino(diphenyl)acetic Acid (2,2-Diphenylglycine) (A) 100 mg NH2 OH

O

New MM 0630.05 Imp. D (EP): 3a,6a-Diphenyltetra- O (A) 50 mg hydroimidazo[4,5-d]imidazole- HN 2,5(1H, 3H)-dione NH HN NH O

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Code Product Price Unit

MM 0630.06 Imp. E (EP): (Carbamoylamino)(diphenyl)acetic Acid O (A) 50 mg HN NH2 OH O MM 0630.08 Imp. F (EP): 5-(4-Methylphenyl)-5-phenylimidazolidine- (A) 100 mg H O 2,4-dione N NH O

MM 0630.07 1-Methyl-5,5-diphenylimidazolidine-2,4-dione (D) 100 mg N O NH O

MM 0630.03 5-(4-Methylphenyl)hydantoin H O (A) 100 mg N NH O Phenytoin Sodium MM 0622.00 Phenytoin Sodium (A) 500 mg H N ONa N O

MM 0630.01 Imp. A (EP): Diphenylmethanone (Benzophenone) (B) 100 mg

O MM 0630.02 Imp. B (EP): Diphenylethanedione (Benzil) O (B) 100 mg

O MM 0630.04 Imp. C (EP): Amino(diphenyl)acetic (A) 100 mg Acid (2,2-Diphenylglycine) NH2 OH

O MM 0630.08 Imp. F (EP): 5-(4-Methylphenyl)-5- (A) 100 mg H O phenylimidazolidine-2,4-dione N NH O

MM 0630.07 1-Methyl-5,5-diphenylimidazolidine-2,4-dione (D) 100 mg N O NH O

MM 0630.03 5-(4-Methylphenyl)hydantoin H O (A) 100 mg N NH O Pholcodine

MM 0037.00 Imp. A (EP) as Hydrochloride Trihydrate: N (A) 250 mg Morphine Hydrochloride Trihydrate [Controlled Substance] x HCl x 3 H 2O

HO O OH MM 0280.00 Imp. A (EP) as Hemisulphate Pentahemihydrate: (A) 250 mg N Morphine Hemisulphate Pentahemihydrate [Controlled Substance] x H2SO4 x 5 H2O

HO O OH 2

MM 0442.00 Imp. B (EP) as Phosphate Hemihydrate: N (A) 100 mg Codeine Phosphate Hemihydrate x H3PO4 [Controlled Substance] x 1/2 H2O

O O OH

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Code Product Price Unit

MM 0004.00 Imp. B (EP) as Monohydrate: Codeine Monohydrate N (A) 100 mg [Controlled Substance] x H2O

O O OH Pilocarpine Hydrochloride

O MM 0338.00 Pilocarpine Hydrochloride N O (A) 500 mg x HCl N

O MM 0338.01 Imp. A (EP) as Hydrochloride: (3R,4R)-3-Ethyl-4- N O (A) 100 mg [(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran- x HCl 2(3H)-one Hydrochloride (Isopilocarpine N Hydrochloride)

OH MM 0338.02 Imp. B (EP) as Sodium Salt: (2S,3R)-2-Ethyl-3- N (A) 100 mg O (hydroxymethyl)-4-(1-methyl-1H-imidazol-5- yl)butanoic Acid Sodium Salt N ONa (Pilocarpic Acid Sodium Salt)

OH MM 0338.03 Imp. C (EP) as Sodium Salt: (2R,3R)-2-Ethyl-3- N (A) 100 mg O (hydroxymethyl)-4-(1-methyl-1H-imidazol-5- yl)butanoic Acid Sodium Salt N ONa (Isopilocarpic Acid Sodium Salt)

Pindolol MM 0082.00 Pindolol (A) 250 mg O N OH H

N H MM 0082.08 Imp. B (EP): 1-[4-[2-Hydroxy-3-[(1-methyl- OH OH (D) 100 mg H H N ethyl)amino]propoxy]-1H-indol-1-yl]-3-[(1- N O N methylethyl)amino]propan-2-ol

MM 0082.06 Imp. C (EP): 1,1'-[(1-Methylethyl)imino]bis[3- OH OH (A) 100 mg (1H-indol-4-yloxy)propan-2-ol] HN O N O NH

MM 0082.02 Imp. D (EP): (2RS)-3-(1H-Indol-4-yloxy) OH (A) 100 mg propane-1,2-diol HN O OH

MM 0082.01 Imp. E (EP): 1H-Indol-4-ol OH (A) 100 mg

N H New MM 0082.04 Imp. F (EP): (2RS)-1-Chloro-3- OH (A) 50 mg (1H-indol-4-yloxy)propan-2-ol HN O Cl

Pioglitazone Hydrochloride MM 0616.06 Imp. C (Pharmeuropa): (5RS)-5-[4-[2- O N (A) 50 mg N O (5-Ethylpyridin-2-yl)ethoxy]benzyl]-3- S N [2-(5-ethylpyridin-2-yl)ethyl]-1,3- thiazolidine-2,4-dione O MM 0616.08 Imp. E (Pharmeuropa): Ethyl 3-[4-[2-(5- N O (A) 50 mg Ethylpyridin-2-yl)ethoxy]phenyl]propanoate O

O MM 0616.04 5-[4-[2-(5-Ethylpyridin-2-yl)ethoxy]benzyl]- NH (A) 100 mg N O 2-iminothiazolidin-4-one S NH

O Pipazetate Hydrochloride MM 0486.06 Bis-(2-piperidinoethyl)ether Dihydrochloride (A) 100 mg x 2 HCl (BPEE Dihydrochloride) N N O MM 0486.02 1,2-Dipiperidinoethane (DPE) (A) 100 mg N N

MM 0486.05 2-(2-Piperidinoethoxy)ethanol Hydrochloride (A) 100 mg x HCl HO N O

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Code Product Price Unit Pipemidic Acid Trihydrate

MM 0401.00 Pipemidic Acid Trihydrate HN (A) 250 mg N N N x 3 H2O N OH

O O Pipenzolate Bromide MM 0783.00 Pipenzolate Bromide (A) 500 mg N + O Br- O OH

MM 0630.01 Diphenylmethanone (Benzophenone) (B) 100 mg O

MM 0783.09 Benzilic Acid O (B) 100 mg

HO OH

Piperacillin

MM 0295.00 Piperacillin N (A) 100 mg O N O OH O O O NH N H N S H O Piperacillin Sodium

MM 0296.00 Piperacillin Sodium N (A) 100 mg NaO N O O O O O NH N H N S H O NaO MM 0253.00 Imp. A (EP) as Sodium Salt: Ampicillin Sodium O (A) 500 mg O NH 2 N H N S H O

MM 0296.05 Imp. E (EP): 1-Ethylpiperazine-2,3-dione N (A) 100 mg NH O O

MM 0296.07 Imp. G (EP): (2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)- N (A) 100 mg carbonyl]amino]-2-phenylacetic Acid N O O O NH OH

O

MM 0026.04 Imp. H (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- O (B) 100 mg OH 7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid O N (6-Aminopenicillanic Acid) H2 N S H Pipradrol Hydrochloride New MM 1099.00 Pipradrol Hydrochloride [Controlled Substance] (A) 100 mg NH OH x HCl

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Code Product Price Unit Piprinhydrinate

MM 0155.00 Piprinhydrinate O on request O H N N Cl N O N N

MM 0155.01 Diphenylpyraline (A) 100 mg O N

O MM 0155.02 8-Chlorotheophylline H (B) 100 mg N N Cl O N N

MM 0490.02 Diphenylmethanol (Benzhydrol) (B) 100 mg OH

Piracetam MM 0083.00 Piracetam O (A) 500 mg N NH2 O MM 0083.05 Imp. A (EP): Pyrrolidin-2-one (2-Pyrrolidone) (B) 100 mg NH O

MM 0083.04 Imp. B (EP): Methyl (2-Oxopyrrolidin-1-yl)acetate O (A) 100 mg N O O

MM 0083.02 Imp. C (EP): Ethyl (2-Oxopyrrolidin-1-yl)acetate O (A) 100 mg N O O

MM 0083.01 Imp. D (EP): (2-Oxopyrrolidin-1-yl)acetic Acid O (A) 100 mg N OH O MM 0083.03 N-Vinyl-2-pyrrolidone (A) 100 mg N O MM 0083.06 2-Chloroacetamide O (C) 100 mg Cl NH2 Piroxicam MM 0084.00 Piroxicam O O (A) 500 mg S N H N N OH O

MM 0084.01 Imp. A (EP): Pyridin-2-amine (2-Pyridylamine) N NH2 (B) 100 mg

MM 0084.08 Imp. B (EP): 4-Hydroxy-N-(pyridin-2-yl)-2H-1,2- O O (A) 100 mg S benzothiazine-3-carboxamide 1,1-Dioxide NH H N N OH O MM 0084.09 Imp. C (EP): 4-Hydroxy-2-methyl-2H-1,2- O O (A) 100 mg S benzothiazine-3-carboxamide1,1-Dioxide N NH2 OH O MM 0084.07 Imp. D (EP): Methyl (1,1-Dioxido-3-oxo-1,2- O (A) 100 mg O benzisothiazol-2(3H)-yl)acetate S N O O O MM 0084.05 Imp. E (EP): Ethyl (1,1-Dioxido-3-oxo-1,2- O (A) 100 mg O benzisothiazol-2(3H)-yl)acetate S N O O O MM 0084.10 Imp. F (EP): 1-Methylethyl (1,1-Dioxido-3-oxo- O (A) 100 mg O 1,2-benzisothiazol-2(3H)-yl)acetate S N O O O

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Code Product Price Unit MM 0084.04 Imp. G (EP): Methyl 4-Hydroxy- 2H-1,2- O O (A) 100 mg S benzothiazine-3-carboxylate 1,1-Dioxide NH O OH O MM 0084.06 Imp. H (EP): Ethyl 4-Hydroxy- 2H-1,2- O O (A) 100 mg S benzothiazine-3-carboxylate 1,1-Dioxide NH O OH O MM 0084.11 Imp. I (EP): 1-Methylethyl 4-Hydroxy-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxylate 1,1-Dioxide NH O OH O MM 0084.02 Imp. J (EP): Methyl 4-Hydroxy-2-methyl-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxylate 1,1-Dioxide N O OH O MM 0084.03 Imp. K (EP): Ethyl 4-Hydroxy-2-methyl-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxylate 1,1-Dioxide N O OH O MM 0084.12 Imp. L (EP): 1-Methylethyl 4-Hydroxy-2-methyl-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxylate 1,1-Dioxide N O OH O O New MM 0084.14 N-(2-Pyridinyl)oxamic Acid H (A) 100 mg N N OH O MM 0084.13 N-Methylsaccharin O (A) 100 mg O S N O MM 0084.15 4-Isopropoxy-2-methyl-N-(2-pyridinyl)-2H- O O (A) 100 mg S 1,2-benzothiazine-3-carboxamide 1,1-Dioxide N H N N O O

MM 0084.16 N,N'-Di-(2-pyridinyl)oxamide O (C) 50 mg H N N N N O H

O MM 0084.17 N-(2-Pyridinyl)oxamic Acid Hydrochloride H on request N N OH x HCl O MM 0084.20 2-(1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetamide O (A) 100 mg O S N NH2 O O MM 0084.21 N-(6-Methyl-2-pyridyl)-4-hydroxy-2-methyl-2H- O O (B) 10 mg S 1,2-benzothiazine-3-carboxamide-1,1-Dioxide N H N N OH O

MM 0084.22 4-Methoxy-2-methyl-N-(2-pyridyl)-2H-1,2- O O (C) 10 mg S benzothiazine-3-carboxamide-1,1-Dioxide N H N N O O

MM 0084.23 2-Methyl-N-2-(1-methylpyridinium)-2H-1,2- O O (B) 10 mg S benzothiazine-3-carboxamide-4-olate 1,1-Dioxide N H N N O O MM 0084.24 4-Hydroxy-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide O O (B) 10 mg S NH NH2 OH O Potassium Sorbate MM 0955.00 Potassium Sorbate O (A) 500 mg OK Povidone MM 0083.03 Imp. A (EP): 1-Ethenylpyrrolidin-2-one (A) 100 mg (1-Vinylpyrrolidin-2-one, N-Vinyl-2-pyrrolidone) N O

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Code Product Price Unit MM 0083.05 Imp. B (EP): Pyrrolidin-2-one (2-Pyrrolidone) H (B) 100 mg N O

MM 0537.01 Vinyl Acetate O (B) 100 mg O Pralidoxime Methyl Sulphate MM 0689.00 Pralidoxime Methyl Sulphate (A) 100 mg N OH O O N S OO MM 0689.01 2-Carboxy-N-methylpyridinium Iodide O (A) 100 mg N OH I-

MM 0689.02 2-Carbamoyl-N-methylpyridinium Methanesulfonate O (A) 100 mg N O O NH2 S O

Prasterone MM 0651.00 O (A) 500 mg

HO

MM 0651.02 16-Dehydropregnenolone Acetate Oxime N (A) 100 mg OH

O

O Pravastatin Sodium MM 0503.00 Pravastatin Sodium O (A) 100 mg OH ONa

OH H O O

OH MM 0503.04 Imp. D (EP): (1S,3S,7S,8S,8aR)-3-Hydroxy-8-[2-[(2R,4R)- O (D) 100 mg 4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl- O 1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Pravastatin Lactone) OH H O O

OH Prazepam New MM 1258.00 Prazepam [Controlled Substance] (A) 100 mg O N

Cl N

MM 0023.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro- H O (A) 100 mg N 2H-1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] Cl N

MM 0028.03 Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl- NH2 (B) 100 mg methanone O Cl

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Code Product Price Unit Praziquantel MM 0615.00 Praziquantel O (A) 250 mg O N N H

MM 0615.02 Imp. B (EP): 2-(Cyclohexylcarbonyl)- O on request O 2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]- N isoquinolin-4-one N

Prazosin Hydrochloride MM 0085.00 Prazosin Hydrochloride O (A) 100 mg N O N N O x HCl N O NH2 MM 0085.04 Imp. A (EP): 2-Chloro-6,7-dimethoxyquinazoline- O N Cl (A) 100 mg 4-amine N O NH2 MM 0085.05 Imp. B (EP): 1,4-Bis(furan-2-ylcarbonyl)piperazine O (A) 100 mg O N N O

O

MM 0085.01 Imp. C (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin- NH (A) 100 mg 4-amine O N N N O NH2 MM 0085.02 Imp. D (EP): 1-(Furan-2-ylcarbonyl)piperazine O (A) 100 mg N HN O MM 0085.03 Imp. E (EP): 2,2'-(Piperazin-1,4-diyl)bis- NH2 (D) 100 mg O (6,7-dimethoxyquinazolin-4-amine) N

N N O O N N

N O NH2 MM 0085.06 2,4-Dichloro-6,7-dimethoxyquinazoline O N Cl (A) 100 mg N O Cl MM 0085.07 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione H (C) 100 mg O N O NH O O Prednisolone MM 0193.00 Prednisolone O (A) 500 mg OH HO OH

O MM 0185.00 Imp. A (EP): Hydrocortisone O (A) 500 mg OH HO OH

O MM 0482.00 Imp. B (EP): 17,21-Dihydroxypregna-1,4- O (A) 250 mg OH diene-3,11,20-trione () O OH

O

192 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit O MM 0194.00 Imp. C -Dihydroxy-3,20-dioxo-pregna- O (A) 500 mg 1,4-dien-21-yl Acetate (Prednisolone Acetate) O HO OH

O MM 0193.01 (20R)-Hydroxyprednisolone HO (C) 10 mg OH HO OH

O MM 0193.02 (20S)-Hydroxyprednisolone HO (D) 50 mg OH HO OH

O Prednisolone Acetate MM 0194.00 Prednisolone Acetate O (A) 500 mg O O HO OH

O MM 0187.00 Imp. A (EP): Hydrocortisone Acetate O (A) 500 mg O O HO OH

O MM 0193.00 Imp. B (EP): Prednisolone O (A) 500 mg OH HO OH

O MM 0194.04 Prednisolone 17-Acetate O (C) 50 mg OH HO O

O

O MM 0194.07 Prednienic Acid O (A) 100 mg OH HO OH

O Prednisolone Pivalate

MM 0304.00 Prednisolone Pivalate O (D) 250 mg O O HO OH

O Prednisolone Sodium Phosphate

MM 0305.00 Prednisolone Sodium Phosphate O O ONa (A) 100 mg P O ONa HO OH

O Prednisolone Sodium Sulfobenzoate

MM 0484.01 Sodium 3-Sulfobenzoate O O O (C) 100 mg S HO ONa

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 193 Table of content Pharmaceutical impurities

Code Product Price Unit Prednisone

O MM 0482.00 Prednisone OH (A) 250 mg O OH

O Prednisone Acetate MM 0196.00 Prednisone Acetate O (A) 250 mg O O O OH

O Pregabalin

New MM 1376.00 Pregabalin NH2 (A) 100 mg O OH New MM 1376.01 rac-Pregabalin NH2 (A) 100 mg O OH Prilocaine Hydrochloride

MM 0563.00 Prilocaine Hydrochloride H (A) 500 mg N N x HCl O H

MM 0563.01 Imp. A (EP): (RS)-2-Chloro-N-(2-methylphenyl)- H (A) 100 mg N Propanamide Cl O MM 0563.02 Imp. B (EP): 2-Methylbenzenamine NH2 (A) 100 mg (o-Toluidine)

MM 0563.03 Imp. C (EP) as Hydrochloride: (RS)-2-Ethylamino- H (A) 50 mg N N-(2-methylphenyl)propanamide Hydrochloride N x HCl H O

MM 0563.04 Imp. D (EP) as Hydrochloride: (RS)-N-(3-Methyl- H (A) 50 mg N phenyl)-2-(propylamino)propanamide Hydrochloride N H x HCl O

MM 0563.05 Imp. E (EP) as Hydrochloride: (RS)-N-(4-Methylphenyl)- H (A) 50 mg N 2-(propylamino)propanamide Hydrochloride N x HCl H O Primidone MM 1030.01 Imp. A (EP) as Hydrate: 2-Ethyl-2-phenylpropane- O NH2 (A) 100 mg diamide Hydrate (Ethylphenylmalonamide Hydrate) NH2 x H 2O O

MM 1030.03 Imp. C (EP): (2RS)-2-Phenylbutanamide (A) 100 mg NH2

O MM 1030.04 Imp. D (EP): (2RS)-2-Cyano-2-phenylbutanamide N (A) 50 mg

NH2

O

MM 1030.05 Imp. E (EP): (2RS)-2-Phenylbutanoic Acid (A) 100 mg OH

O Probenecid MM 0657.00 Probenecid O (A) 500 mg OH N S O O

194 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Procainamide Hydrochloride

MM 0550.00 Procainamide Hydrochloride O (A) 500 mg N N x HCl H H2 N

MM 0550.02 Procainamide N-Oxide Dihydrochloride O (A) 100 mg O N N x 2 HCl H H2N Procaine Hydrochloride

MM 0596.00 Procaine Hydrochloride O (A) 500 mg N O x HCl

H2N MM 0094.03 4-Aminobenzoic Acid O (B) 100 mg OH

H2N

New MM 0550.03 N-Acetylprocainamide O (A) 100 mg N O N H N H Progesterone MM 0222.00 Progesterone O (A) 500 mg

O MM 0222.03 Imp. C (EP): (20R)-20-Hydroxypregn-4-en-3-one HO (A) 100 mg

O MM 0222.01 Imp. E (EP): (20R)-3-Oxopregn-4-en-20-yl Acetate O (D) 100 mg O

O MM 0222.08 11α-Hydroxyprogesterone O (A) 100 mg HO

O MM 0222.12 11-Ketoprogesterone O (A) 100 mg O

O MM 0222.14 Pregnanediol (5β-Pregnane-3α,20(S)-diol) HO (A) 100 mg

HO H MM 0222.15 Pregnanetriol (5β-Pregnane-3α,17,20(S)-triol) HO on request OH

HO H Proguanil Hydrochloride MM 0162.05 Imp. B (EP): 4-Chloroaniline Cl (B) 100 mg

NH2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 195 Table of content Pharmaceutical impurities

Code Product Price Unit Prolintane Hydrochloride MM 0663.00 Prolintane Hydrochloride (A) 100 mg N x HCl

Promazine Hydrochloride MM 0290.00 Promazine Hydrochloride (A) 500 mg N N x HCl

S MM 0290.01 Imp. A (EP): 3-(10H-Phenothiazin-10-yl)-N,N- (A) 100 mg N dimethylpropan-1-amine S-Oxide (Promazine Sulphoxide) N

S O MM 0290.02 N,N-Dimethyl-3-chloropropylamine Hydrochloride (B) 100 mg Cl N x HCl

MM 0157.02 Phenothiazine H (B) 100 mg N

S Promethazine Hydrochloride MM 0412.00 Promethazine Hydrochloride (A) 500 mg N N x HCl S

MM 0157.02 Imp. A (EP): Phenothiazine (B) 100 mg

NH S

MM 0412.02 Imp. B (EP) as Hydrochloride: (2RS)-N,N- (A) 100 mg Dimethyl-2-(10H-phenothiazin-10-yl)propan- N N 1-amine Hydrochloride (Isopromethazine x HCl Hydrochloride) S

MM 0412.03 Imp. C (EP) as Hydrochloride: (2RS)-N-Methyl- (A) 50 mg H 1-(10H-phenothiazin-10-yl)propan-2-amine N N Hydrochloride (Norpromethazine Hydrochloride) x HCl S

MM 0412.04 Imp. D (EP): (2RS)-N,N-Dimethyl-1-(10H-phenothiazin- (A) 100 mg 10-yl)propan-2-amine S-Oxide (Promethazine Sulphoxide) N N S O

MM 0412.05 Promethazine Sulphoxide N-Oxide Hydrochloride (A) 100 mg O N N x HCl S O

MM 0412.06 (2RS)-N-Methyl-2-(10H-phenothiazin-10-yl)propan- (A) 100 mg H 1-amine Hydrochloride N N (Norisopromethazine Hydrochloride) x HCl S

Propafenone Hydrochloride

MM 0405.00 Propafenone Hydrochloride O O N (A) 500 mg OH H x HCl

MM 0405.02 Imp. A (EP): 1-(2-Hydroxyphenyl)-3-phenylpropan- O OH (A) 100 mg 1-one

MM 0405.03 Imp. B (EP) as Hydrochloride: (2E)-1-[2-[(2RS)- O O N (A) 50 mg H 2-Hydroxy-3-(propylamino)propoxy]phenyl]- OH x HCl 3-phenylprop-2-en-1-one Hydrochloride

196 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0405.04 Imp. C (EP): 1-[2-[[(2RS)-Oxiranyl]methoxy] O O (A) 50 mg O phenyl]-3-phenylpropan-1-one

MM 0405.05 Imp. D (EP): 1-[2-[(2RS)-2,3-Dihydroxy-propoxy] O O OH (A) 50 mg phenyl]-3-phenylpropan-1-one OH

MM 0405.06 Imp. E (EP): 1-[2-[(2RS)-3-Chloro-2-hydroxy- O O Cl (A) 50 mg propoxy]phenyl]-3-phenylpropan-1-one OH

MM 0405.07 Imp. F (EP): 1,1'-[2-Hydroxypropane- O O O O (A) 50 mg 1,3-diylbis(oxy-2,1-phenylene)]bis(3- OH phenylpropan-1-one)

MM 0405.09 Imp. H (EP): (2RS)-2-Phenyl-2,3-dihydro-4H-1- (A) 100 mg benzopyran-4-one

O

O

MM 0405.01 5-Hydroxypropafenone Hydrochloride O O N (A) 100 mg OH H x HCl

OH Propentofylline MM 0875.01 3-Methyl-7-propylxanthine (A) 100 mg O N HN

O N N

MM 0875.02 1-(3-Hydroxypropyl)-3-methyl-7-propylxanthine (A) 100 mg O N HO N

O N N

MM 0875.03 1,7-Bis-(5-oxohexyl)-3-methylxanthine O (A) 100 mg

O O N N

O N N

Propofol MM 0461.00 Propofol OH (A) 250 mg

MM 0461.03 Imp. A (EP): 2,4-Bis(1-methylethyl)phenol OH (A) 100 mg

MM 0461.04 Imp. C (EP): 2-(1-Methylethyl)phenol OH (C) 100 mg

MM 0461.02 Imp. E (EP): 3,3',5,5'-Tetrakis(1- (A) 100 mg Methylethyl)bisphenyl-4,4'-diol HO OH

MM 0461.05 Imp. F (EP): 3-(1-Methylethyl)phenol (C) 100 mg HO

MM 0461.08 Imp. G (EP): 2-(1-Methylethoxy)-1,3-bis (A) 100 mg (1-methylethyl)benzene O

MM 0461.06 Imp. H (EP): 4-(1-Methylethyl)phenol HO (C) 100 mg

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 197 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0461.07 Imp. I (EP): Oxydibenzene O (B) 100 mg

MM 0461.13 Imp. J (EP): 2,6-Bis(1-methylethyl)benzene-1,4-dione O (A) 50 mg

O MM 0461.11 Imp. K (EP): 1-(1-Methylethoxy)-2-(1-methylethyl)benzene (A) 100 mg O

MM 0461.15 Imp. M (Pharmeuropa): 2,6-Diisopropylbenzoic Acid O OH (A) 50 mg

Propranolol Hydrochloride MM 0043.00 Propranolol Hydrochloride (A) 500 mg OH H O N x HCl

MM 0043.01 Imp. A (EP): (2RS)-3-(Naphthalen-1- OH (A) 100 mg yloxy)propane-1,2-diol (Diol Derivative) O OH

MM 0043.03 Imp. B (EP) as Hydrochloride: 1,1'-[(1- OH OH (A) 100 mg Methylethyl)imino]bis[3-(naphthalen-1- O N O yloxy)propan-2-ol] Hydrochloride (Tertiary Amine Derivative Hydrochloride) x HCl

MM 0043.02 Imp. C (EP): 1,3-Bis(naphthalen-1-yloxy)- OH (A) 50 mg propan-2-ol (Bis-ether Derivative) O O

MM 0043.04 1-Naphthol (B) 100 mg

OH

MM 0043.05 1-(1-Naphtyloxy)-2,3-epoxypropane O (A) 100 mg O

Propyl Gallate MM 1037.00 Propyl Gallate O (A) 500 mg HO O

HO OH Propyl Parahydroxybenzoate MM 0432.00 Propyl Parahydroxybenzoate O (A) 500 mg O HO MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg OH HO MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate O (A) 500 mg (Methyl Parahydroxybenzoate) O HO MM 0498.00 Imp. C (EP): Ethyl 4-Hydroxybenzoate O (A) 500 mg (Ethyl Parahydroxybenzoate) O HO MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate O (A) 500 mg (Butyl Parahydroxybenzoate) O HO MM 0432.01 Sodium Propyl Parahydroxybenzoate O (B) 100 mg O NaO Propylhexidrine Hydrochloride MM 0664.00 Propylhexidrine Hydrochloride (A) 100 mg x HCl NH

198 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Propyphenazone

MM 0036.00 Propyphenazone O (A) 500 mg N N

MM 0036.05 Imp. A (EP): Phenazone O (A) 100 mg N N

MM 0036.04 Imp. C (EP): 4-[(1RS)-1,3-Dimethylbutyl]- O (A) 50 mg 1,5-dimethyl-2-phenyl-1,2-dihydro-3H- pyrazol-3-one N N

Protionamide MM 0844.01 Protionamide Sulphoxide O (A) 50 mg S

NH2 N Proxymetacaine Hydrochloride

MM 0404.00 Proxymetacaine Hydrochloride O (A) 500 mg H2N N x HCl O

O MM 0404.01 3-Amino-4-propoxybenzoic Acid Hydrochloride O (A) 100 mg H2N OH x HCl

O MM 0404.02 Proxymetacaine N-Oxide Dihydrochloride O (C) 50 mg H2N N x 2 HCl O O O Proxyphylline MM 1284.00 Proxyphylline OH (A) 250 mg O N N

O N N

Pseudoephedrine Hydrochloride MM 2115.01 Methcathinone Hydrochloride O (A) 100 mg NH (2-Methylamino-1-phenylpropan-1-one Hydrochloride) x HCl [Controlled Substance]

MM 2115.04 (1S,2S)-N-Acetylpseudoephedrine OH (A) 100 mg N

O MM 2115.05 (1S,2S)-N,O-Diacetylpseudoephedrine O (A) 100 mg O N

O OH MM 0652.00 Imp. A (EP) as Hydrochloride: H (A) 500 mg Ephedrine Hydrochloride [Drug Precursor] N x HCl

MM 1147.00 Imp. A (EP) as Sulphate: Ephedrine Sulphate OH (A) 250 mg [Drug Precursor] H N x H2SO4

2 MM 2115.03 (1S,2S)-O-Acetylpseudoephedrine Hydrochloride O (A) 50 mg O x HCl NH

New MM 2115.10 (+)-Norpseudoephedrine Hydrochloride (Cathine Hydrochloride) OH (A) 100 mg NH2 [Controlled Substance] x HCl

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 199 Table of content Pharmaceutical impurities

Code Product Price Unit New MM 2115.11 (-)-Pseudoephedrine ((1R,2R)-Pseudoephedrine) OH (A) 100 mg NH

Pyrazinamide MM 0385.00 Pyrazinamide O on request N NH2 N MM 0385.01 Imp. A (EP): Pyrazine-2-carboxylic Acid O (A) 100 mg N OH N Pyridostigmine Bromide

MM 0429.00 Pyridostigmine Bromide O (A) 100 mg N+ Br- N O

MM 0429.02 Imp. B (EP) as Iodide: 3-Hydroxy-1-methyl- (A) 100 mg I- pyridinium Iodide N+ HO Pyridoxine Hydrochloride MM 0021.00 Pyridoxine Hydrochloride N (A) 500 mg OH HO x HCl

OH MM 0021.01 Imp. A (EP) as Hydrochloride: 6-Methyl- N (D) 100 mg 1,3-dihydrofuro[3,4-c]pyridin-7-ol x HCl Hydrochloride HO O MM 0021.02 Imp. B (EP) as Hydrochloride: 5-(Hydroxymethyl)- N (A) 100 mg 2,4-dimethylpyridin-3-ol Hydrochloride OH x HCl HO

MM 0021.03 Pyridoxine Diacetate N (A) 100 mg O HO O O O MM 0021.05 Pyridoxal Hydrochloride N (A) 100 mg OH HO x HCl

O MM 0021.06 Pyridoxamine Dihydrochloride N (A) 100 mg OH HO x 2 HCl

NH2 MM 0021.07 4-Pyridoxic Acid N (D) 50 mg OH HO

O OH Quetiapine Fumarate

O New MM 1130.00 Quetiapine Fumarate OH 100 mg N OH O N N x S O HO 2 New MM 1130.15 Imp. A (Pharmeuropa) as Maleate: 2-[2-[4- O (A) 50 mg O (Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin- N O 1-yl]ethoxy]ethyl Acetate Maleate N N O

OH S x OH

O MM 1130.01 Imp. B (Pharmeuropa) as Dihydrochloride: NH (A) 100 mg 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine N N Dihydrochloride x 2 HCl S

200 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit O New MM 1130.16 Imp. F (Pharmeuropa) as Maleate: [2-[(2-Amino- N OH (A) 50 mg phenyl)thio]phenyl][4-[2-(2-hydroxyethoxy)ethyl]- O N piperazin-1-yl]methanone Maleate NH2 O S OH x OH

O MM 1130.09 Imp. G (Pharmeuropa): Dibenzo[b,f][1,4]thiazepin- H (A) 100 mg N O 11(10H)-one S

O MM 1130.10 Imp. H (Pharmeuropa): 2-[2-[4-(Dibenzo[b,f][1,4]- O (A) 50 mg thiazepin-11-yl)-1-oxidopiperazin-1-yl]ethoxy]- N OH ethanol (Quetiapine N-Oxide) N N

S

OH New MM 1130.14 Imp. I (Pharmeuropa) as Fumarate: N OH (A) 50 mg O 2-[4-(Dibenzo[b,f][1,4]thiazepin- N N 11-yl)piperazin-1-yl]-ethanol Fumarate x S O HO O New MM 1130.17 Imp. K (Pharmeuropa) as Fumarate: N-(2- N OH (A) 50 mg OH [[2-([4-[2-(2-Hydroxyethoxy)ethyl]piperazin- O N 1-yl]carbonyl)phenyl]thio]phenyl)acetamide O Fumarate S x O NH HO O Quinapril Hydrochloride MM 0011.01 4-Amino-6-chlorobenzene-1,3-disulphonamide O O O O (B) 100 mg S S (Salamide) H2 N NH2 Cl NH2

MM 0010.05 Imp. B (Pharmeuropa): (2S)-2-[[(1S)-1- O (A) 100 mg H (Ethoxycarbonyl)-3-phenylpropyl]amino]- N propanoic Acid OH O O

Quinine Dihydrochloride MM 0458.00 Quinine Dihydrochloride H (A) 500 mg

N HO H x 2 HCl O

N Quinuclidinyl Benzilate MM 0783.09 Benzilic Acid O (B) 100 mg OH HO

MM 0825.02 3-Quinuclidinol N (A) 100 mg

OH Rabeprazole Sodium MM 0618.01 Rabeprazole Sodium O on request O Na N S N N O MM 0618.00 Rabeprazole O on request

O H N S N N O

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Code Product Price Unit MM 0618.02 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl] O (A) 100 mg methyl]thio]-1H-benzimidazole H N O S N N MM 0618.03 Rabeprazole Sulphone O (A) 100 mg H O O N O S N N MM 0618.04 Rabeprazole N-Oxide O (D) 100 mg H N O O S N N O MM 0618.05 Rabeprazole Sulphone N-Oxide O (A) 100 mg H O O N O S N N O MM 0618.07 2-Chloromethyl-3-methyl-4-(3-methoxypropoxy) O (A) 100 mg pyridine Hydrochloride O x HCl Cl

N Racecadotril

New MM 1337.00 Racecadotril O (A) 100 mg O N H O S

O Hydrochloride

MM 0738.00 Raloxifene Hydrochloride HO S (A) 100 mg OH x HCl O N O

O MM 0738.01 Imp. C (EP): [6-Hydroxy-2-(4-hydroxyphenyl)-1- O (A) 50 mg benzothiophen-3-yl][4-[2-(piperidin-1-yl)ethoxy]- N phenyl]methanone N-Oxide (Raloxifene N-Oxide) O HO

S OH Ramipril MM 0448.05 Imp. D (EP): Ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3- H (A) 100 mg Methyl-1,4-dioxodecahydro-2H-cyclopenta[4,5]- H pyrrolo[1,2-a]pyrazin-2-yl]-4-phenylbutanoate O N H (Ramipril Diketopiperazine) N O

O O

MM 0010.05 Imp. F (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- O (A) 100 mg H 3-phenylpropyl]amino]propanoic Acid N OH

O O

MM 0291.04 Imp. G (EP): Methylbenzene (Toluene) (C) 100 mg

MM 0448.04 Imp. M (EP): (2R,3R)-2,3-Bis(benzoyloxy)- O OH (A) 100 mg O butanedioic Acid (Dibenzoyltartric Acid) O O O HO O

202 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0448.11 (2S,3aS,6aS)-Octahydro-cyclopenta[b]pyrrole- (A) 100 mg 2-carboxylic Acid Phenylmethyl Ester Hydrochloride O O x HCl HN H H

Ranitidine Hydrochloride MM 0086.00 Ranitidine Hydrochloride H H (A) 500 mg O N N N S x HCl

NO2

H H MM 0086.02 Imp. A (EP): N,N'- O O (A) 100 mg N N Bis[2-[[[5-[(dimethylamino)methyl]furan-2-yl]- N S S N methyl]sulphanyl]ethyl]-2-nitroethene- NO2 1,1-diamine

MM 0086.01 Imp. B (EP): 2-[[[5-[(Dimethylamino)methyl]- O NH2 (A) 100 mg N S furan-2-yl]methyl]sulphanyl]ethanamine

H H MM 0086.03 Imp. C (EP): N-[2-[[[5-[(Dimethylamino)- O (A) 100 mg N N methyl]furan-2-yl]methyl]sulphinyl]ethyl]-N'- N S methyl-2-nitroethene-1,1-diamine O (Ranitidine Sulphoxide) NO2

MM 0086.06 Imp. D (EP) as Sodium Salt: N-[2-[[[5- H (A) 100 mg O N ONa [(Dimethylamino)methyl]furan-2-yl]- N S methyl]sulphanyl]ethyl]-2-nitroacetamide Sodium Salt NO2

MM 0086.05 Imp. E (EP): N-[2-[[[5-[(Dimethyloxidoamino)- O H H (D) 100 mg O N N methyl]furan-2-yl]methyl]sulphanyl]ethyl]- N S N'-methyl-2-nitroethene-1,1-diamine (Ranitidine N-Oxide) NO2

MM 0086.17 Imp. F (EP) as Hydrochloride: [5-[(Dimethyl- O (A) 100 mg N OH x HCl amino)methyl]furan-2-yl]methanol Hydrochloride

S N MM 0086.07 Imp. G (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4- OH (A) 100 mg thiazin-2-one Oxime N N H MM 0086.08 Imp. H (EP): N-Methyl-2-nitroacetamide NO2 (A) 100 mg

O N H MM 0086.10 Imp. I (EP): 2,2'-Methylenebis[N-[2-[[[5-[(dimethyl- H H (A) 100 mg O N N amino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-N'- N S NO2 methyl-2-nitroethene-1,1-diamine] NO2 N S O N N H H MM 0220.09 Imp. K (EP): N-Methyl-1-methylthio-2- NO2 (A) 100 mg nitroethenamine ((EZ)-N-Methyl-1-(methyl- sulphanyl)-2-nitroethen-1-amine) S N H Ranolazine Dihydrochloride MM 1320.01 2-[(2-Methoxyphenoxy)methyl]oxirane O (A) 100 mg O

O Reagents MM 0334.01 Diethylhexylphthalate (Bis-(2-ethylhexyl) Phthalate) O (C) 500 mg O O

O OH MM 0334.02 3-(N-Morpholino)propane Sulfonic Acid (MOPS) N S (C) 500 mg O O O MM 0334.03 3-(N-Morpholino)ethane Sulfonic Acid (MES) O O (C) 500 mg S N OH O MM 0334.08 Salicylaldehyde Azine HO (A) 100 mg N N

OH

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 203 Table of content Pharmaceutical impurities

Code Product Price Unit Repaglinide

MM 0944.00 Repaglinide O (A) 100 mg

N O OH

N O H

MM 0944.02 Imp. B (EP): [3-Ethoxy-4-(ethoxycarbonyl)- O (A) 100 mg phenyl]acetic Acid O O

HO O MM 0944.01 Imp. C (EP) as N-Acetyl-L-glutamate: (1S)- O O (A) 100 mg 3-Methyl-1-[2-(piperidin-1-yl)phenyl]butan- N HO OH 1-amine N-Acetyl-L-glutamate x HN NH2 O Ribavirin MM 0542.00 Ribavirin O (A) 250 mg H2N N HO N N O OH OH MM 0542.01 Imp. A (EP): 1- -D-Ribofuranosyl-1H-1,2,4- O (D) 100 mg triazole-3-carboxylic Acid HO N HO N N O OH OH MM 0542.03 Imp. C (EP): 1H-1,2,4-Triazole-3-carboxylic Acid O (D) 100 mg HO N N N H MM 0542.04 Imp. D (EP): 1H-1,2,4-Triazole-3-carboxamide O (D) 100 mg H2N N N N H MM 0542.05 1-(5-O-Benzoyl- -D-ribofuranosyl)-1H-1,2,4- O (D) 100 mg triazole-3-carboxamide (5'-O-Benzoylribavirin) H2N N O N N O O OH OH MM 0542.06 Imp. F (EP): 1-(5-O-Acetyl- -D-ribofuranosyl)-1H- O (D) 100 mg 1,2,4-triazole-3-carboxamide (5'-O-Acetylribavirin) H2 N N O N N O O OH OH Riboflavin MM 0030.00 Riboflavin OH (A) 500 mg HO OH

OH N N O NH N O Risedronate Sodium 2.5 Hydrate MM 0777.00 Risedronate Sodium 2.5 Hydrate OH (A) 100 mg O OH N HO P x 2,5 H2OOH P ONa O New MM 0777.02 Imp. B (Pharmeuropa): [1-Hydroxy-2-(pyridin- OH (A) 50 mg O 2-yl)ethane-1,1-diyl]bis(phosphonic Acid) P OHHO OH N P OH O OH New MM 0777.03 Imp. C (Pharmeuropa): [1-Hydroxy-2-(pyridin- O (A) 50 mg N 4-yl)ethane-1,1-diyl]bis(phosphonic Acid) P OHHO OH P OH O

204 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0491.00 Risperidone N (A) 100 mg N F N O N O MM 0491.01 Imp. A (EP): 3-[2-[4-[(E)-(2,4-Difluorophenyl)- N (D) 100 mg (hydroxyimino)methyl]piperidin-1-yl]ethyl]-2- N F methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- N pyrimidin-4-one O N F HO MM 0491.02 Imp. B (EP): 3-[2-[4-[(Z)-(2,4-Difluorophenyl)- N (A) 100 mg (hydroxyimino)methyl]piperidin-1-yl]ethyl]-2- N F methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- N pyrimidin-4-one O N F OH MM 0491.03 Imp. C (EP): (9RS)-3-[2-[4-(6-Fluoro- OH (D) 100 mg 1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9- N hydroxy-2-methyl-6,7,8,9-tetrahydro-4H- N F pyrido[1,2-a]pyrimidin-4-one (9-Hydroxyrisperidone) N O

N O N MM 0491.04 Imp. D (EP): 3-[2-[4-(5-Fluoro-1,2-benzisoxazol- F (D) 100 mg 3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9- N tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one N O N O MM 0491.05 Imp. E (EP): (6RS)-3-[2-[4-(6-Fluoro-1,2- N (D) 50 mg benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6- N F dimethyl-6,7,8,9-tetrahydro-4H-pyrido- N [1,2-a]pyrimidin-4-one O N O N MM 0491.08 Imp. F (EP): 2-[2-Methyl-4-oxo-6,7,8,9-tetrahydro- O (A) 100 mg 4H-pyrido[1,2-a]pyrimidin-3-yl]ethyl 4-(6-Fluoro- N F 1,2-benzisoxazol-3-yl)piperidin-1-carboxylate O N O N O MM 0491.10 Imp. H (EP): 3-[2-[4-(2,4-Difluorobenzoyl)piperidin- N (A) 100 mg 1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido- N F [1,2-a]pyrimidin-4-one N O

O F MM 0491.09 3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin- N (A) 100 mg 1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H- N F pyrido-[1,2-a]pyrimidin-4-one N O

O OH MM 0491.13 Imp. L (EP) as Hydrochloride: 3-(2-Chloroethyl)- N (A) 100 mg 2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- N x HCl pyrimidin-4-one Hydrochloride (Risperidone Cl Piperidopyrimidinone Intermediate Hydrochloride) O

MM 0491.18 3-[2-[4-[2-Fluoro-4-[4-(6-fluoro- F (D) 50 mg 1,2-benzisoxazol-3-yl)piperidin- 1-yl]benzoyl]piperidin-1-yl]ethyl]-2-methyl- 6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]- O N pyrimidin-4-one N N N N O

O F Ritodrine Hydrochloride MM 0063.06 Imp. A (BP): Tyramine NH2 (B) 100 mg

HO

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 205 Table of content Pharmaceutical impurities

Code Product Price Unit Ritonavir MM 1034.00 Ritonavir (A) 100 mg S N O O H N S N N N O H H O OH N

Ronidazole MM 1026.01 (1-Methyl-5-nitroimidazol-2-yl)methanol (A) 100 mg N O2 N OH N Rosiglitazone Maleate

MM 0522.01 Rosiglitazone Maleate N O (D) 100 mg O O OH N S x NH OH

O O New MM 0522.04 Imp. A (Pharmeuropa): N (A) 50 mg 3-[4-[2-[Methyl(pyridin- O 2-yl)amino]ethoxy]phenyl]propanamide N NH2

O Rosuvastatin Calcium MM 0936.01 4-(4-Fluorophenyl)-6-isopropyl- O O (A) 100 mg S 2-[methyl(methylsulfonyl)amino]pyrimidine- N 5-carbaldehyde N N

O F MM 0936.02 4-(4-Fluorophenyl)-6-isopropyl- O O (A) 100 mg S 2-[methyl(methylsulfonyl)amino]pyrimidine- N 5-methanol N N

HO F New MM 0936.03 5-Oxorosuvastatin Methyl Ester O O (A) 100 mg S N

N N

O OH F

O O Rotigotine New MM 1403.02 Despropylrotigotine ((6S)-5,6,7,8-Tetrahydro- OH (A) 50 mg 6-[[2-(2-thienyl)ethyl]amino]-1-naphthalenol)

N S H New MM 1403.03 (S)-2-Amino-5-methoxytetralin (S)-Mandelate O OH (A) 50 mg OH x O NH2

New MM 1403.04 Despropylrotigotine Methyl Ether Hydrochloride O (A) 100 mg x HCl

N S H Roxatidine Acetate Hydrochloride

MM 0597.03 N-[3-[3-[(Piperidin-1-yl)methyl]phenoxy]propan- O (A) 50 mg 1-yl]phthalimide Hydrochloride N O N x HCl

O

206 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Rutoside Trihydrate MM 0109.03 Imp. C (EP) as Dihydrate: 2-(3,4-Dihydroxyphenyl)- HO OH (A) 100 mg 3,5,7-trihydroxy-4H-1-benzopyran-4-one Dihydrate O ( Dihydrate) O HO x 2 H2O

OH OH Saccharin Sodium MM 0818.00 Saccharin Sodium O O (A) 500 mg S NNa

O Salbutamol Sulphate MM 0381.00 Salbutamol Sulphate OH (A) 500 mg H N x H2SO4 HO

OH 2 OH MM 0381.02 Imp. B (EP): (1RS)-2-[(1,1-Dimethylethyl)- H (A) 50 mg amino]-1-(4-hydroxyphenyl)ethanol N

HO

MM 0381.03 Imp. C (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]- OH H (A) 50 mg 1-(4-hydroxy-3-methylphenyl)ethanol N HO

MM 0381.05 Imp. E (EP): (1RS)-2-[Benzyl(1,1-dimethyl- (A) 100 mg ethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)- phenyl]ethanol OH N

HO

OH MM 0381.07 Imp. G (EP) as Hydrochloride: (D) 50 mg 2-[Benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy- O 3-(hydroxymethyl)phenyl]ethanone Hydrochloride N x HCl

HO

OH MM 0381.08 4-[2-[(1,1-Dimethylethyl)amino]ethyl]-2-methylphenol H (A) 100 mg N

HO

New MM 0381.09 Imp. I (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]-1- OH (A) 50 mg H [4-(benzyloxy)-3-(hydroxymethyl)phenyl]ethanol N

O

OH O MM 0381.10 Imp. J (EP) as Hydrochloride: 2-[(1,1-Dimethyl- H (D) 50 mg ethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)- N phenyl]ethanone Hydrochloride (Salbutamone x HCl Hydrochloride) HO OH OH MM 0381.17 4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2- H (A) 50 mg ethylphenol Hydrobromide N x HBr HO

Salicylic Acid MM 0045.00 Salicylic Acid O (A) 500 mg OH

OH MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid O (B) 100 mg HO

OH

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Code Product Price Unit MM 0045.02 Imp. B (EP): 4-Hydroxyisophthalic Acid O O (A) 100 mg HO OH OH MM 0045.11 Imp. C (EP): Phenol (B) 100 mg

OH MM 0045.12 Imidazole Salicylate O (A) 100 mg H O N OH N H MM 0045.13 Choline Salicylate O on request O OH N OH MM 0045.14 N,N-Diethylsalicylamide O (A) 100 mg N

OH Salmeterol Xinafoate OH MM 0536.03 Imp. B (EP): (1RS)-1-[4-Hydroxy-3-(hydroxy- H (A) 100 mg methyl)phenyl]-2-[[6-(2-phenylethoxy)hexyl]- N amino]ethanol HO O

OH OH MM 0536.07 Imp. F (EP): (1RS)-1-(4-Hydroxy-3-methylphenyl)- H (A) 50 mg 2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol N

HO O

Secnidazole MM 0119.00 Secnidazole OH (A) 100 mg

N O2N N MM 0012.02 2-Methyl-4-nitroimidazole NH (B) 100 mg O2N N Secobarabital New MM 1361.00 Secobarbital [Controlled Substance] H (A) 100 mg O N O NH

O Selegiline Hydrochloride New MM 0216.00 Selegiline Hydrochloride (A) 100 mg N x HCl

MM 0656.00 Imp. C (EP) as Hydrochloride: (1RS, 2SR)-2- OH (A) 500 mg NH2 Amino-1-phenylpropan-1-ol Hydrochloride x HCl (Phenylpropanolamine Hydrochloride)

and enatiomer New MM 0216.09 Imp. D (EP) as Racemate Hydrochloride: H (A) 100 mg N N-[(1RS)-1-Methyl-2-phenylethyl]prop-2-yn-1- x HCl amine Hydrochloride (rac-Demethylselegiline Hydrochloride)

Sertraline Hydrochloride

MM 0317.01 Sertraline Hydrochloride HN (A) 100 mg

x HCl

Cl Cl

MM 0317.00 Sertraline HN (A) 100 mg

Cl Cl

208 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0317.05 Imp. B (EP) as Hydrochloride: (1RS,4RS)-N- HN (A) 100 mg Methyl-4-phenyl-1,2,3,4-tetrahydronaphthalen- 1-amine Hydrochloride x HCl

and enantiomer

MM 0317.06 Imp. C (EP) as Hydrochloride: (1RS,4RS)-4- HN (D) 100 mg 4-Chlorophenyl)-N-methyl-1,2,3,4-tetrahydro- naphthalen-1-amine Hydrochloride

x HCl

Cl and enantiomer

MM 0317.10 Imp. E (EP): (2R)-Hydroxyphenylacetic Acid O (A) 100 mg ((R)-Mandelic Acid) OH OH MM 0792.03 Imp. E (EP) as Racemate: O (A) 100 mg Hydroxyphenylacetic Acid (Mandelic Acid) OH OH MM 0317.09 Imp. F (EP) as Racemate: 4-(3,4-Dichlorophenyl)- O (A) 100 mg 3,4-dihydronaphthalen-1(2H)-one (Sertraline Tetralone Derivative)

Cl Cl Sibutramine Hydrochloride

MM 0991.04 Imp. A (Pharmeuropa) as Hydrochloride: (1RS)- Cl (A) 50 mg 1-[1-(2-Chlorophenyl)cyclobutyl]-N,N,3-trimethyl- x HCl butan-1-amine Hydrochloride N MM 0991.05 Imp. B (Pharmeuropa) as Hydrochloride: (1RS)- (A) 50 mg 1-[1-(3-Chlorophenyl)cyclobutyl]-N,N,3-trimethyl- Cl x HCl butan-1-amine Hydrochloride N MM 0991.06 Imp. C (Pharmeuropa) as Hydrochloride: (1RS)- (A) 50 mg 1-[1-(4-Chlorophenyl)cyclobutyl]-N,N-dimethyl- x HCl pentan-1-amine Hydrochloride N Cl Cl MM 0991.02 Imp. D (Pharmeuropa) as Hydrochloride: (1RS)- HN (A) 100 mg 1-[1-(4-Chlorophenyl)cyclobutyl]- x HCl N,3-dimethylbutan-1-amine Hydrochloride (N-Monodesmethylsibutramine Hydrochloride)

MM 0991.07 Imp. E (Pharmeuropa): (4-Chlorophenyl)acetonitrile (A) 50 mg N Cl MM 0991.03 Imp. G (Pharmeuropa) as Hydrochloride: (1RS)- Cl (A) 100 mg NH2 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan- x HCl 1-amine Hydrochloride (N,N-Didesmethyl- sibutramine Hydrochloride)

MM 0991.09 Imp. H (Pharmeuropa): 2-(4-Chlorophenyl)-2-(prop- (A) 50 mg 2-en-1-yl)pent-4-enenitrile N Cl MM 0991.10 Imp. I (Pharmeuropa): (1RS)-1-[1-(4-Chlorophenyl)- (A) 50 mg cyclobutyl]-3-methylbutan-1-ol OH Cl MM 0991.11 Imp. J (Pharmeuropa): 1-[1-(4-Chlorophenyl)cyclo- (A) 50 mg butyl]-3-methylbutan-1-one O Cl Sibutramine Hydrochloride Monohydrate MM 0991.00 Sibutramine Hydrochloride Monohydrate (A) 100 mg x HCl x H2O N Cl

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Code Product Price Unit Sildenafil Citrate

MM 0254.00 Sildenafil Citrate O O (D) 100 mg N HN HO O O O N x HO S N N HO OH N O O MM 0254.09 Sildenafil O (D) 100 mg N HN O O N S N N N O MM 0254.01 4-[[2-Ethoxy-5-[(4-methyl-1-piperazinyl)- O on request sulfonyl]benzoyl]amino]-1-methyl-3-propyl-1H- N O H2N pyrazole-5-carboxamide O O N S N N H N O MM 0254.02 2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl] O O O (A) 100 mg S benzoic Acid N OH N O MM 0254.04 Imp. B (Pharmeuropa): 5-[2-Ethoxy-5-[(4- O (A) 100 mg N methyl-4-oxidopiperazin-1-yl)sulfonyl]phenyl]- HN 1-methyl-3-propyl-6,7-dihydro-1Hpyrazolo- O O N S [4,3-d]pyrimidin-7-one (Desethylsildenafil) N N N O O MM 0254.05 4-Amino-1-methyl-3-propyl-1H-pyrazole- O (A) 100 mg 5-carboxamide N H 2N N H2N

MM 0254.06 Imp. D (Pharmeuropa): 4-Ethoxy-3-(1-methyl- O (D) 100 mg 7-oxo-3-propyl-6,7-dihydro-1Hpyrazolo[4,3-d]- HN N pyrimidin-5-yl)benzenesulfonic Acid O O N S (3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H- HO N pyrazolo[4,3-d]pyrimidin-5yl]-4-ethoxy- O benzenesulfonic Acid)

MM 0254.08 1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H- O (D) 100 mg N pyrazolo[4,3-d]pyrimidin-5-yl)- HN 4-ethoxyphenyl]sulfonyl]piperazine O O N S (Desmethylsildenafil) N N HN O MM 0254.11 3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H- O (D) 100 mg N pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxy-N- HN [2-(methylamino)ethyl]- O O N S benzenesulfonamide N N H NH O

O MM 0254.21 2-Ethoxy-5-(4-methylpiperazine-1-sulfonyl)benzaldehyde O O (A) 100 mg S (1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine) N N O MM 0254.22 Imp. C (Pharmeuropa): 5-[2-Hydroxy-5-[(4- O (D) 100 mg N methylpiperazin-1-yl)sulfonyl]phenyl]-1- HN methyl-3-propyl-6,7-dihydro-1H-pyrazolo- O O N S [4,3-d]pyrimidin-7-one (Desethylsildenafil) N N N OH MM 0254.29 5-(2-Ethoxyphenyl)-1-methyl-3n-propyl- O (A) 100 mg N 1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one HN N N

O Silybin

O MM 0472.00 Silybin OH (A) 100 mg HO O O O OH OH OH O

210 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Simvastatin MM 0158.00 Simvastatin O (A) 100 mg O OH H O O

MM 0158.01 Imp. A (EP) as Sodium Salt: (3R,5R)-7- O (A) 100 mg [(1S,2S,6R,8S,8aR)-8-[(2,2-Dimethylbutanoyl)oxy]- OH ONa 2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen- 1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Tenivastatin OH H Sodium Salt; Simvastatin Hydroxy Acid Sodium Salt) O O

MM 0158.02 Imp. B (EP): (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(Acetyloxy)- O (A) 100 mg 6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- O O hexahydronaphthalen-1-yl 2,2-Dimethylbutanoate (Simvastatin O H Acetate Ester) O O

MM 0158.03 Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo- O (A) 100 mg 3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen- O 1-yl 2,2-Dimethylbutanoate (Anhydrosimvastatin) H O O

MM 0050.00 Imp. E (EP): Lovastatin O (A) 100 mg O OH H O O

Sodium Benzoate MM 0730.00 Sodium Benzoate O (A) 500 mg ONa

Sodium Cromoglicate MM 0039.00 Sodium Cromoglicate O O (A) 500 mg O O NaO ONa OH O O O O

MM 0039.01 Succinophenone; Diphenacyl O (A) 100 mg

O

MM 0039.02 1,3-Bis(2-acetyl-3-hydroxyphenoxy)-2-propanol HO OH (A) 100 mg

OH O O O O MM 0039.03 Imp. A (EP): 1-(2,6-Dihydroxyphenyl)ethanone OH (B) 100 mg (2',6'-Dihydroxyacetophenone)

OH O MM 0039.04 Imp. B (EP): Diethyl 5,5'-[(2-hydroxypropane- O O (A) 100 mg O O 1,3-diyl)dioxy]bis(4-oxo-4H-1-benzopyran-2- O O carboxylate (Ethyl Cromoglicate) OH O O O O Sodium Cyclamate MM 0678.05 Cyclamic Acid H (A) 100 mg N OH S O O

MM 0093.17 Imp. B (EP) as Hydrochloride: Aniline Hydrochloride NH2 (B) 100 mg x HCl (Phenylamine Hydrochloride)

MM 0678.03 Imp. C (EP): Cyclohexanamine NH2 (C) 100 mg

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Code Product Price Unit MM 0678.04 Imp. D (EP): N-Cyclohexylcyclohexanamine H (C) 100 mg N

Sodium Fluoride

MM 0734.00 Sodium Fluoride NaF (A) 500 mg Sodium Picosulfate

NaO O O ONa MM 0054.00 Sodium Picosulfate S S (A) 500 mg O O O O

N

HO O ONa MM 0054.01 Imp. A (EP): 4-[(RS)-(4-Hydroxyphenyl)- S (A) 100 mg (pyridin-2-yl)methyl]phenyl Sodium Sulphate O O (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]- phenyl Sodium Sulphate) N

MM 0031.01 Imp. B (EP): 4,4'-[(Pyridin-2-yl)methylene]- HO OH (A) 100 mg diphenol (4,4'-(Pyridin-2-ylmethylene)di- phenol) N

O ONa MM 0054.02 Imp. C (EP): 2-[(RS)-(Pyridin-2-yl)[4-(sulphonato- S (D) 50 mg oxy)phenyl]methyl]phenyl Disodium Sulphate O O (2,4'-[(Pyridin-2-yl)-methylene]bisphenyl Bis- (Sodium Sulphate)) NaO O S N O O

MM 0031.04 2,4'-[(Pyridin-2-yl)methylene]bisphenol (2-[(RS)- HO (A) 50 mg (4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenol) OH N

Sodium Salicylate New MM 1370.00 Sodium Salicylate O (A) 250 mg ONa

OH Sodium Thiophene-2-carboxylate MM 1081.00 Sodium Thiophene-2-carboxylate O (A) 250 mg S ONa

Sorbic Acid MM 0954.00 Sorbic Acid O (A) 500 mg OH Sotalol Hydrochloride OH MM 0046.00 Sotalol Hydrochloride H (A) 100 mg N O O x HCl S N H MM 0046.01 Imp. A (EP) as Hydrochloride: N-[4-[2- H (A) 100 mg N [(1-Methylethyl)amino]ethyl]phenyl]- O O x HCl S methanesulphonamide Hydrochloride N H O MM 0046.02 Imp. B (EP) as Hydrochloride: N-[4-[[(1- H (A) 100 mg Methylethyl)amino]acetyl]phenyl]- N methanesulphonamide Hydrochloride O O x HCl S N H MM 0046.03 Imp. C (EP):N-(4-Formylphenyl) O (A) 100 mg methanesulphonamide O O S N H

212 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0197.00 Spironolactone O (A) 500 mg O

O S

O MM 0197.01 Imp. F (EP): (2'R)-3',4'-Dihydro-5'H-spiro[androst- O (A) 100 mg 4,6-diene-17,2'-furan]-3,5'-dione () O

O MM 1285.00 Stanozolol OH (A) 100 mg

N N H H Stavudine MM 0534.00 Stavudine O (A) 100 mg HN HO O N O

MM 0534.01 Imp. A (EP): 5-Methylpyrimidine-2,4(1H,3H)-dione O (A) 100 mg (Thymine) HN

O N H MM 0534.03 Imp. C (EP): 1-(2-Deoxy- -D-erythro-pentofuranosyl)- O (A) 100 mg 5-methylpyrimidine-2,4(1H,3H)-dione (Thymidine) HN HO O N O

OH Strychnine Nitrate MM 0658.00 Strychnine Nitrate (A) 500 mg H N

H x HNO3 N H O O MM 0658.02 Strychnine N-Oxide Hydrochloride O (A) 100 mg H N

H x HCl N H O O Sulfacetamide MM 0579.00 Sulfacetamide O O O (A) 500 mg S N H H2N Sulfacetamide Sodium MM 1087.00 Sulfacetamide Sodium Monohydrate O O O (A) 500 mg S N x H2O Na H2N MM 0227.05 Imp. A (EP): Sulfanilamide O O (A) 100 mg S NH2

H2N Sulfadiazine

MM 0623.00 Sulfadiazine O O N (A) 500 mg S NN H H2N

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Code Product Price Unit

MM 0623.03 Imp. A (EP): Pyrimidin-2-amine N (A) 100 mg

H2N N MM 0227.04 Imp. B (EP): 4-Aminobenzenesulfonic Acid O O (A) 100 mg S (Sulphanilic Acid) OH

H2N MM 0227.05 Imp. D (EP): 4-Aminobenzenesulfonamide O O (A) 100 mg S (Sulfanilamide) NH2

H2N

MM 0623.02 Imp. E (EP): N-[4-(Pyrimidin-2-ylsulfamoyl)- O O N (A) 50 mg S phenyl]acetamide (Acetylsulfadiazine) NN O H N H MM 0623.07 N-[(4-Aminophenyl)sulfonyl]-N-(pyrimidin-2-yl)acetamide O O N (A) 50 mg S (Acetylsulfadiazine) NN

H2N O Sulfadimidine MM 0581.00 Imp. A (Pharmeuropa): 4-Amino-N-(4-methyl-2- (A) 500 mg pyrimidyl)benzenesulphonamide (Sulfamerazine) O O N S NN H H2N

MM 623.00 Imp. B (Pharmeuropa): 4-Amino-N-pyrimidin-2- O O N (A) 500 mg S ylbenzenesulphonamide (Sulfadiazine) NN H H2N MM 0883.00 Imp. C (Pharmeuropa): (4-Aminophenylsulphonyl)- O O NH (A) 100 mg S guanidine (Sulfaguanidine) NNH2 H H2N MM 0227.05 Imp. D (Pharmeuropa): 4-Aminobenzenesulphonamide O O (A) 100 mg S (Sulfanilamide) NH2

H2N MM 0579.00 Imp. E (Pharmeuropa): N-[(4-Aminophenyl)sulfonyl]- O O O (A) 500 mg S acetamide (Sulfacetamide) N H H2N MM 0227.04 Imp. F (Pharmeuropa): 4-Aminobenzenesulphonic O O (A) 100 mg S Acid (Sulphanilic Acid) OH

H2N Sulfadimethoxine Sodium

MM 1020.00 Sulfadimethoxine Sodium O (A) 500 mg

O O N N S N O Na H2N Sulfafurazole MM 0583.00 Sulfafurazole N (A) 500 mg O O O S N H H2N Sulfaguanidine MM 0883.00 Sulfaguanidine O O NH (A) 100 mg S NNH2 H H2N MM 0227.05 Imp. A (EP): 4-Aminobenzenesulphonamide O O (A) 100 mg S (Sulphanilamide) NH2

H2N MM 0883.02 Imp. B (EP): N-[(4-Aminophenyl)sulphonyl]urea O O O (A) 50 mg S (Sulphacarbamide) NNH2 H H2N

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Code Product Price Unit Sulfamerazine MM 0581.00 Sulfamerazine (A) 500 mg O O N S NN H H2N MM 0227.05 Sulphanilamide O O (A) 100 mg S NH2

H2N Sulfamethoxazole MM 0227.00 Sulfamethoxazole (A) 500 mg O O O S N N H H2N MM 0227.01 Imp. A (EP): N-[4-[(5-Methylisoxazol-3-yl)- (A) 100 mg O O sulphamoyl]phenyl]acetamide O S O N N H N H MM 0227.03 Imp. B (EP): 4-[[(4-Aminophenyl)sulphonyl]amino]- (A) 100 mg N-(5-methylisoxazol-3-yl)benzenesulphonamide O O S O O O N N S H N H H2N MM 0227.02 Imp. C (EP): 5-Methylisoxazol-3-amine (B) 100 mg O H2N N MM 0227.04 Imp. D (EP): 4-Aminobenzenesulphonic Acid O O (A) 100 mg S (Sulphanilic Acid) OH

H2N MM 0227.05 Imp. E (EP): 4-Aminobenzenesulphonamide O O (A) 100 mg S (Sulphanilamide) NH2

H2N Sulfamethylphenazole MM 1108.00 Sulfamethylphenazole (A) 100 mg O O S N N N H H2N

Sulfaquinoxaline Sodium MM 0702.00 Sulfaquinoxaline Sodium NH 2 on request Na N N S O O N Sulfasalazine MM 0045.00 Imp. H (EP): Salicylic Acid (A) 500 mg

HO

O OH Sulfathiazole

MM 0578.00 Sulfathiazole O O N (A) 500 mg S N S H H2N Sulfinpyrazone

New MM 1309.02 Imp. B (EP): 1,2-Diphenyl-4-[2-(phenylsulfanyl)- O (A) 50 mg ethyl]pyrazolidine-3,5-dione N N S O

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Code Product Price Unit Sulindac MM 0624.00 Sulindac (A) 500 mg OH O S O F

MM 0051.00 Sulpiride O O (A) 500 mg O S N N H2N H O MM 0051.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine (A) 100 mg N H2 N

MM 0051.02 O O (A) 100 mg Imp. B (EP): Methyl 2-Methoxy-5-sulphamoylbenzoate H2N S O O O O O MM 0051.03 Imp. C (EP): Ethyl 2-Methoxy-5-sulphamoylbenzoate H 2N (A) 100 mg S O O O O O MM 0051.04 Imp. D (EP): 2-Methoxy-5-sulphamoylbenzoic Acid H2N (A) 100 mg S OH O O O O MM 0051.05 Imp. E (EP): 2-Methoxy-5-sulphamoylbenzamide H 2N (A) 100 mg S NH 2 O O MM 0051.06 Imp. F (EP): 1-Ethyl-2-[[(2-methoxy-5- (A) 100 mg NH 2 O O O sulphamoylbenzoyl)amino]methyl]pyrrolidine S N N 1-Oxide (Sulpiride N-Oxide) O H O

MM 0051.07 Imp. G (EP): (RS)-N-[(1-Ethylpyrrolidin-2-yl)methyl]- O O (A) 100 mg O 2-hydroxy-5-sulphamoylbenzamide S N N H2N H OH O O MM 0051.08 5-Sulphamoylsalicylic Acid H2N (A) 100 mg S OH O OH O O MM 0051.09 5-Sulphosalicylic Acid Dihydrate HO (C) 100 mg S OH x 2 H 2O O OH Sumatriptan Succinate MM 0310.04 Imp. D (EP) as Maleate: N,N-Dimethyl- H (A) 100 mg N O O O 2-[5-[(methylsulfamoyl)methyl]-1H-indol- S N OH 3-yl]ethanamine N-Oxide Maleate x H OH N O O MM 0310.05 Imp. E (EP): [3-(2-Aminoethyl)-1H-indol-5-yl]- H (A) 100 mg N N-methylmethanesulfonamide O O S N H NH2 Suplatast Tosilate MM 0722.01 Methyl Toluene-4-sulphonate O O (B) 100 mg S O

Tamoxifen Citrate

MM 0053.00 Citrate O (A) 100 mg O N HO OH x HO HO O

O

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Code Product Price Unit MM 0053.02 Imp. B (EP): 1-[4-(2-Dimethylaminoethoxy) (A) 100 mg phenyl]-1,2-diphenylbutan-1-ol O N

OH

MM 0053.14 Imp. C (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenyl- on request ethenyl]phenoxy]-N,N-dimethylethanamine O N

O MM 0053.15 Imp. C (EP) E-Isomer: 2-[4-[(E)- N (A) 50 mg 1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine

MM 0053.16 Imp. D (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylprop- (A) 50 mg 1-enyl]phenoxy]-N,N-dimethylethanamine O N

O MM 0053.17 Imp. D (EP) E-Isomer: 2-[4-[(E)-1,2-Diphenylprop- N (A) 50 mg 1-enyl]phenoxy]-N,N-dimethylethanamine

MM 0053.05 Imp. E (EP):2-[2-[(EZ)-1,2-Diphenylbut-1-enyl)phenoxy]- (A) 100 mg N,N-dimethylethanamine

O N

MM 0053.12 Imp. F (EP) as Hydrochloride: 2-[4-[(Z)-1,2-Diphenylbut- (A) 100 mg 1-enyl]phenoxy]-N-methylethanamine Hydrochloride O N H x HCl

MM 0053.07 Imp. G (EP): (2RS)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]- (A) 100 mg 2-phenylbutan-1-one O N

O MM 0053.08 1,2-Diphenylbutan-1-one (A) 100 mg

O MM 0053.09 1-(4-Methoxyphenyl)-1,2-diphenylbutan-1-ol (A) 100 mg O

OH

MM 0053.10 (EZ)-1-(4-Hydroxyphenyl)-1,2-diphenylbut-1-ene (C) 50 mg OH

MM 0053.18 Tamoxifen N-Oxide (A) 100 mg O N O

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Code Product Price Unit Tamsulosin Hydrochloride

MM 0938.00 Tamsulosin Hydrochloride O O (D) 100 mg H Sx HCl N O NH2 O O MM 0938.02 Imp. A (EP) as Hydrochloride: 5-[(2R)-2- O (A) 100 mg [Bis[2-(2-ethoxyphenoxy)ethyl]amino]- propyl]-2-methoxybenzenesulfonamide O Hydrochloride x HCl O O N S O NH2 O O MM 0938.03 Imp. B (EP): 5-[(2R)-2-Aminopropyl]- O O (A) 100 mg S H2N 2-methoxybenzenesulfonamide NH2

O

MM 0938.04 Imp. C (EP) as Hydrochloride: 2-Methoxy-5-[(2R)- O O (A) 100 mg H Sx HCl 2-[(2-phenoxyethyl)amino]propyl]benzene- N O NH2 sulfonamide Hydrochloride O

MM 0938.05 Imp. D (EP) as Hydrochloride: 2-Methoxy- O O (A) 100 mg H Sx HCl 5-[(2R)-2-[[2-(2-methoxyphenoxy)ethyl]- N O NH2 amino]propyl]benzenesulfonamide O Hydrochloride O

MM 0938.06 Imp. E (EP): 5-Formyl-2-methoxybenzene- O O (A) 50 mg S Sulfonamide O NH2 O MM 0938.07 Imp. F (EP) as Hydrochloride: 2-(2-Ethoxy- (A) 100 mg phenoxy)ethanamine Hydrochloride NH2 x HCl O O

MM 0938.10 Imp. G (EP) as Racemate Hydrochloride: O O (A) 50 mg H S 5-[(2RS)-2-[[2-(2-Ethoxyphenoxy)ethyl]- N x HCl O NH2 amino]propyl]-2-methoxybenzenesulfonamide O Hydrochloride (Tamsulosin Racemate O Hydrochloride)

MM 0938.01 Imp. H (EP) as Racemate Hydrochloride: (A) 100 mg H (2RS)-N-[2-(2-Ethoxyphenoxy)ethyl]- N x HCl 1-(4-methoxyphenyl)propan- O O 2-amine Hydrochloride O

MM 0938.09 Imp. I (EP): 1-(2-Bromoethoxy)-2-ethoxybenzene (A) 100 mg Br O O Telmisartan MM 0939.01 Imp. A (EP): 4-Methyl-6-(1-methyl-1H-benz- (A) 100 mg imidazol-2-yl)-2-propyl-1H-benzimidazole N N

NH N

O O MM 0939.10 Methyl 4'-(Bromomethyl)biphenyl-2-carboxylate Br (A) 100 mg

Temazepam

MM 0087.00 Temazepam [Controlled Substance] O (A) 100 mg N OH Cl N

MM 0023.01 Imp. A (EP): [5-Chloro-2-(methylamino)- (B) 100 mg NH phenyl]phenylmethanone O (5-Chloro-2-(methylamino)benzophenone) Cl

218 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0080.00 Imp. B (EP): Oxazepam [Controlled Substance] H O (D) 100 mg N OH Cl N

Tenofovir Disoproxil Fumarate MM 1329.00 Tenofovir Disoproxil Fumarate (A) 100 mg O NH2 O N O OH N O O P O N N O O x O O HO O O

Tenoxicam MM 0084.01 Imp. A (EP): Pyridin-2-amine H2 N (B) 100 mg N MM 0247.01 Imp. B (EP): Methyl 4-Hydroxy-2-methyl-2H-thieno[2,3-e] O O (A) 100 mg S 1,2-thiazine-3-carboxylate 1,1-Dioxide N O S OH O MM 0247.04 Imp. C (EP): N-Methylthiophene-2-carboxamide (A) 100 mg H S N O MM 0247.06 Imp. E (EP): 2-Methylthieno[2,3-d]isothiazol-3(2H)-one O O (A) 100 mg S 1,1-Dioxide N S O New MM 0247.08 Imp. G (EP): 4-Hydroxy-2-methyl-2H-thieno- O O (A) 50 mg S [2,3-e]1,2-thiazine-3-carboxamide 1,1-Dioxide N NH2 S OH O New MM 0247.09 Imp. H (EP): 3-[(Methylamino)sulfonyl]- O O (A) 50 mg S thiophene-2-carboxylic Acid N H OH S O MM 0247.10 2-(Methoxycarbonyl)-3-thiophenesulfonyl Chloride O O (A) 100 mg S Cl O S O Terazosin Hydrochloride Dihydrate MM 0843.00 Terazosin Hydrochloride Dihydrate O (A) 100 mg N O N N O x HCl x 2 H2O N O NH2 MM 0085.04 Imp. A (EP): 2-Chloro-6,7- O N Cl (A) 100 mg dimethoxyquinazolin-4-amine N O NH2 MM 0843.02 Imp. B (EP): 1-(4-Hydroxy- O (A) 100 mg 6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)- N tetrahydrofuran-2-yl]carbonyl]piperazine O N N O

N O OH MM 0085.01 Imp. C (EP): 6,7-Dimethoxy- NH (A) 100 mg 2-(piperazin-1-yl)quinazolin-4-amine O N N

N O NH2

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Code Product Price Unit MM 0843.04 Imp. D (EP) as Hydrochloride: 1-(4-Amino-6,7- O (A) 100 mg dimethoxyquinazolin-2-yl)-4-formylpiperazine N Hydrochloride O N N x HCl N O NH2 MM 0085.03 Imp. E (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7- NH2 (D) 100 mg O dimethoxyquinazolin-4-amine) N

N N O O N N

N O NH2 MM 0085.00 Imp. K (EP) as Hydrochloride: O (A) 100 mg Prazosin Hydrochloride N O N N O x HCl N O NH2 MM 0085.02 Imp. L (EP): 1-(Furan-2-ylcarbonyl)piperazine O (A) 100 mg N HN O MM 0085.05 Imp. M (EP): 1,4-Bis(furan-2- O (A) 100 mg ylcarbonyl)piperazine O N N O

O MM 0843.15 Imp. N (EP): 1-[[(2RS)-Tetrahydrofuran-2-yl]carbonyl] O (A) 100 mg piperazine N HN O MM 0843.16 Imp. O (EP): 1,4-Bis[(tetrahydrofuran-2-yl)carbonyl] O (A) 100 mg piperazine O N N O

O Terbinafine Hydrochloride MM 0696.00 Terbinafine Hydrochloride (A) 100 mg

N x HCl

MM 0696.02 Imp. A (EP) as Hydrochloride: N-Methyl-C-(naphthalen- (A) 100 mg 1-yl)methanamine Hydrochloride (Secundary Amine x HCl Hydrochloride) NH

MM 0696.03 Imp. B (EP) as Hydrochloride: (2Z)-N,6,6-Trimethyl- (D) 100 mg N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine x HCl Hydrochloride (cis-Terbinafine Hydrochloride) N

MM 0696.04 Imp. C (EP) as Hydrochloride: (2E)- N (D) 100 mg N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept- x HCl 2-en-4-yn-1-amine Hydrochloride (trans-iso- Terbinafine Hydrochloride)

MM 0696.05 Imp. D (EP) as Hydrochloride: (2E)-N,6,6-Trimethyl- (D) 100 mg N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn- x HCl 1-amine Hydrochloride (4-Methylterbinafine N Hydrochloride)

MM 0696.07 N-Demethylterbinafine Hydrochloride (D) 50 mg

N x HCl H

MM 0696.10 Imp. F (EP) as Hydrochloride: (2Z)- (D) 50 mg N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept- x HCl 2-en-4-yn-1-amine Hydrochloride (cis-Iso- N terbinafine Hydrochloride)

Terbutaline Sulphate

MM 0708.01 Imp. A (EP): 3,5-Dihydroxybenzoic Acid O (B) 100 mg HO -Resorcylic Acid) OH

OH

220 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0708.03 Imp. B (EP) as Hemisulphate: (4RS)- OH (D) 100 mg 2-(1,1-Dimethylethyl)-1,2,3,4-tetrahydroisoquinoline- HO x 1/2 H2SO4 4,6,8-triol Hemisulphate N

OH Terfenadine MM 0055.00 Terfenadine (A) 500 mg

N OH OH

MM 0055.04 Imp. A (EP): 1-[4-(1,1-Dimethylethyl)phenyl]- (A) 100 mg 4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butan- 1-one (Terfenadone) N O OH

MM 0055.07 Imp. B (EP): (1RS)-1-[4-(1,1-Dimethylethyl)phenyl]- (A) 100 mg 4-[4-(diphenylmethyl)piperidin-1-yl]butan-1-ol N OH

MM 0055.12 Imp. E (EP) as Hydrochloride: 1-[(4RS)- (A) 100 mg 4-[4-(1,1-Dimethylethyl)phenyl]- 4-hydroxybutyl]piperidine-4-carboxylic Acid N Hydrochloride HO OH

O x HCl MM 0055.09 Imp. G (EP): [1-[4-[4-(1,1-Dimethylethyl)- (A) 100 mg phenyl]but-3-enyl]piperidin-4- yl]diphenylmethanol N

OH

MM 0055.10 Imp. H (EP): (A) 100 mg [1-[4-[4-(1,1-Dimethylethyl)phenyl]butyl]piperidin- 4-yl]diphenylmethanol N

OH

MM 0055.02 Imp. I (EP): Diphenyl(piperidin-4-yl)methanol NH (B) 100 mg (Azacyclonol) OH

MM 0055.03 Imp. J (EP): Ethyl 1-[(4RS)- (A) 100 mg 4-[4-(1,1-Dimethylethyl)phenyl]-4-hydroxybutyl]- piperidine-4-carboxylate N O OH

O Testosterone

MM 0323.00 Testosterone OH (A) 500 mg

O MM 0323.01 Imp. A (EP): Androst-4-ene-3,17-dione O (A) 100 mg ()

O MM 0323.02 Imp. B (EP): 3-Ethoxyandrosta-3,5-dien-17-one O (A) 100 mg (Androstenedione Ethylenolether)

O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 221 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0323.03 Imp. C -Hydroxyandrost-4-en-3-one OH (A) 100 mg ()

O MM 0323.04 Imp. D (EP): Androst-4-ene- -diol OH (A) 100 mg -)

HO MM 0323.05 Imp. E (EP): 3-Oxoandrost-4-en- -yl Acetate O (A) 100 mg (Testosterone Acetate) O

O MM 0565.00 Imp. F -Hydroxy- -androstan-3-one OH (A) 250 mg (Androstanolone, Stanolone)

O H MM 0323.07 Imp. G (EP): Androsta-1,4-diene-3,17-dione O (A) 100 mg (Androstadienedione)

O MM 0864.00 Imp. H -Hydroxyandrosta-1,4-dien-3-one OH (A) 100 mg (Boldenone)

O MM 0323.12 Imp. I -Hydroxyandrosta-4,6-dien-3-one OH (A) 100 mg -testosterone)

O MM 0323.13 Imp. J (EP): 3-Methoxyandrosta-3,5-dien- O (A) 100 mg 17-one (Androstenedione Methylenolether)

O Testosterone Benzoate MM 0493.00 Testosterone Benzoate O (D) 250 mg O

O MM 0323.00 Testosterone OH (A) 500 mg

O MM 0278.01 Benzoic Acid O (B) 100 mg OH

Testosterone Enantate MM 1119.00 Testosterone Enantate O (A) 100 mg O

O MM 0863.08 Imp. B (EP): 3-Oxoandrost-4-en- -yl Hexanoate O (A) 100 mg () O

O

222 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0323.00 Imp. D -Hydroxyandrost-4-en-3-one OH (A) 500 mg (Testosterone)

O MM 0863.00 Testosterone Isocaproate O (A) 100 mg O

O MM 0323.00 Imp. A (EP): Testosterone OH (A) 500 mg

O MM 0323.05 Imp. B (EP): 3-Oxoandrost-4-en- -yl Acetate O (A) 100 mg (Testosterone Acetate) O

O MM 0897.00 Imp. C (EP): O (A) 100 mg O

O MM 0863.07 Imp. D (EP): 3-Oxoandrost-4-en- -yl 2- O (A) 100 mg Methylpropanoate () O

O MM 0863.08 Imp. E (EP): 3-Oxoandrost-4-en- -yl O (A) 100 mg Hexanoate (Testosterone Caproate) O

O MM 1119.00 Imp. F (EP): Testosterone Enantate O (A) 100 mg O

O MM 0863.09 Imp. G (EP): 3-Oxoandrost-4-en- -yl O (A) 100 mg 4-Methylpentanoate O (Epitestosterone Isocaproate)

O Testosterone Phenylpropionate MM 1394.00 Testosterone Phenylpropionate O (A) 100 mg O

O Testosterone Propionate MM 0897.00 Testosterone Propionate O (A) 100 mg O

O

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Code Product Price Unit MM 0323.05 Imp. A (EP): 3-Oxoandrost-4-en- -yl Acetate O (A) 100 mg (Testosterone Acetate) O

O MM 0863.07 Imp. B (EP): 3-Oxoandrost-4-en- -yl 2-Methyl- O (A) 100 mg propanoate (Testosterone Isobutyrate) O

O MM 0323.00 Imp. C (EP): Testosterone OH (A) 500 mg

O MM 0897.04 Imp. D (EP): 3-Oxoandrosta-1,4-dien- -yl O (C) 50 mg Propanoate O

O MM 0897.05 Imp. E (EP): 3-Oxoandrosta-4,6-dien- -yl O (A) 100 mg Propanoate O

O Tetracaine Hydrochloride MM 0504.00 Tetracaine Hydrochloride O (A) 500 mg N O x HCl N H MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid O (B) 100 mg OH

H2N MM 0504.01 Imp. B (EP): 4-(Butylamino)benzoic Acid O (A) 100 mg OH N H MM 0504.04 Imp. C (EP): Methyl 4-(Butylamino)benzoate O (A) 100 mg O

N H O MM 0504.02 Tetracaine N-Oxide O (A) 100 mg N O

N H Tetracycline Hydrochloride MM 0452.00 Tetracycline Hydrochloride OH O OH O O (A) 500 mg OH NH2 H H x HCl OH HO N Tetramisole Hydrochloride MM 0703.00 Tetramisole Hydrochloride N S (A) 500 mg x HCl N Tetrazepam

MM 0091.00 Tetrazepam [Controlled Substance] O (A) 100 mg N

Cl N

224 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0091.06 Imp. B (EP): 7-Chloro-5-cyclohexyl-1,3-dihydro-2H- H O (A) 100 mg N 1,4-benzodiazepin-2-one Cl N

MM 0091.07 Imp. C (EP): 7-Chloro-5-cyclohexyl-1-methyl- O (A) 100 mg N 1,3-dihydro-2H-1,4-benzodiazepin-2-one

Cl N

MM 0091.03 Imp. E (EP): 7-Chloro-5-(cyclohex-1-enyl)-1,3- H O (A) 100 mg N dihydro-2H-1,4-benzodiazepin-2-one (Nortetrazepam) Cl N

MM 0091.04 6-Chloro-2-methyl-4-oxo-4H-3,1-benzoxazine N (A) 100 mg O Cl O O MM 0091.52 2-Bromo-4'-chloro-2'-(cyclohexylcarbonyl)acetanilide Br on request NH O Cl

Tetryzoline Hydrochloride MM 0088.00 Tetryzoline Hydrochloride (A) 100 mg HN N x HCl

MM 0088.03 Imp. A (EP): (1RS)-1,2,3,4-Tetrahydronaphthalene-1- N (A) 100 mg carbonitrile -Cyanotetraline)

MM 0088.02 1,2,3,4-Tetrahydro-1-naphthalenecarboxylic Acid O OH (A) 100 mg

MM 0088.04 Methyl 1,2,3,4-Tetrahydro-1-naphthalenecarboxylate O O (A) 100 mg

MM 0088.05 N-(2-Aminoethyl)-1,2,3,4-tetrahydro- H (A) 100 mg O N naphthalene-1-yl-carboxamide Hydrochloride NH 2 ((1,2,3,4-Tetrahydro-1-naphthyl)formyl- x HCl ethylenediamine Hydrochloride)

MM 0088.06 2-(1,2,3,4-Tetrahydro-1-naphthalenyl)-1H-imidazole (A) 100 mg HN N Hydrochloride x HCl

Thalidomide MM 0940.00 O (A) 100 mg

N O NH O O Thebaine New MM 0244.00 Thebaine [Controlled Substance] (A) 100 mg N

O O O

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Code Product Price Unit Theobromine MM 0577.00 Theobromine O (A) 500 mg N HN O N N

Theophylline

O MM 0176.00 Theophylline H (A) 500 mg N N O N N

MM 0494.00 Imp. A (EP): Caffeine O (A) 500 mg N N

O N N

MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione O (A) 100 mg H (3-Methylxanthine) HN N

O N N

O MM 0176.02 Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4- H (A) 100 mg N dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide N O O N NH2

MM 0176.01 Imp. D (EP): N-Methyl-5-(methylamino)-1H-imidazole- O (A) 100 mg N 4-carboxamide (Theophyllidine) N H HN N H

OH MM 0603.00 Imp. F (EP): Etofylline O (A) 500 mg N N

O N N

MM 0176.04 1-Methylxanthine O on request N N O N N H H MM 0176.05 7-Methylxanthine O (A) 100 mg N HN O N N H Theophylline-Ethylenediamine MM 0494.00 Imp. A (EP): Caffeine O (A) 500 mg N N

O N N

MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione O (A) 100 mg H (3-Methylxanthine) HN N

O N N

O MM 0176.02 Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4- H (A) 100 mg N dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)form- N amide O O N NH2

MM 0176.01 Imp. D (EP): N-Methyl-5-(methylamino)-1H- O (A) 100 mg imidazole-4-carboxamide (Theophyllidine) N N H HN N H

OH MM 0603.00 Imp. F (EP): Etofylline O (A) 500 mg N N

O N N

MM 0577.00 Imp. G (EP): Theobromine O (A) 500 mg N HN

O N N

226 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Thiamazole MM 0889.00 Thiamazole S (A) 500 mg N NH

MM 0889.02 Imp. B (EP): 1-Methyl-1H-imidazole (B) 100 mg N N MM 0889.03 Imp. C (EP): 1-Methyl-2-(methylsulphanyl)-1H-imidazole S (A) 100 mg N N MM 0889.04 Imp. C (EP) as Hydrochloride: 1-Methyl-2-(methylsulphanyl)- S (A) 100 mg N x HCl 1H-imidazole Hydrochloride N Thiamine Hydrochloride

MM 0049.00 Thiamine Hydrochloride (Vitamin B1) S N (A) 500 mg N+ N x HCl HO Cl- NH2 New MM 0049.07 Imp. A (EP) as Chloride: 3-[(4-Amino-2- S N (A) 100 mg methylpyrimidin-5-yl)methyl]-4-methyl-5- N+ N [2-(sulfonatooxy)ethyl]thiazolium Chloride O HO S Cl- (Thiamine Chloride Sulfate Ester) O NH2 O New MM 0049.09 Imp. C (EP) as Chloride Hydrochloride: 3-[(4- S N (A) 100 mg x HCl Amino-2-methylpyrimidin-5-yl)methyl]-5-(2- N+ N chloroethyl)-4-methylthiazolium Chloride Cl Hydrochloride (Chlorothiamine Chloride Cl- NH2 Hydrochloride)

MM 0049.05 Imp. E (EP): 3-[(4-Amino-2-methylpyrimidin-5-yl) S S N (A) 100 mg methyl]-5-(2-hydroxyethyl)-4-methylthiazol-2(3H)-thione N N (Thioxothiamine) HO NH2 MM 0049.02 5-(2-Hydroxyethyl)-4-methylthiazole (A) 100 mg N S OH

MM 0049.04 4-Amino-5-hydroxymethyl-2-methylpyrimidine N OH (A) 100 mg Hydrochloride x HCl N NH 2 Thiamphenicol MM 0737.00 Thiamphenicol O O (A) 500 mg OH S O Cl N H Cl OH Thioctic Acid MM 0127.00 Thioctic Acid O (A) 500 mg OH S S Thiopental Sodium and Sodium Carbonate New MM 1312.03 Imp. C (EP): 5-Ethyl-5-(1-ethylpropyl)-2-thioxo-2,3- H (A) 50 mg O N S dihydropyrimidine-4,6(1H,5H)-dione NH

O

Thioridazine Hydrochloride New MM0116.00 Thioridazine Hydrochloride (A) 250 mg

N N x HCl S

S MM 0116.05 2-Methylthiophenothiazine (A) 100 mg

NH S

S

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Code Product Price Unit Tiabendazole

MM 0602.00 Tiabendazole H (A) 500 mg N S N N

MM 0602.01 Imp. A (EP): Benzene-1,2-diamine NH2 (C) 100 mg NH2 Tiamulin Hydrogen Fumarate

MM 0394.00 Tiamulin Hydrogen Fumarate O (A) 100 mg N O O S OH x O H HO

O HO MM 0460.10 Fumaric Acid O (B) 100 mg HO OH O MM 0394.04 Imp. A (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)- (A) 100 mg 6-Ethenyl-5,8-dihydroxy-4,6,9,10-tetramethyl- HO O octahydro-3a,9-propano-3aH-cyclopentacyclo- H octen-1(4H)-one (Mutilin)

HO New MM 0394.05 Imp. B (EP) as Hydrochloride: 2-(Benzylsulfanyl)- (A) 50 mg N,N-diethylethanamine Hydrochloride N S x HCl MM 0394.06 Imp. C (EP) as Dihydrochloride: 2,2'-(Disulfane- (A) 50 mg 1,2-diyl)bis(N,N-diethylethanamine) N S Dihydrochloride S N x 2 HCl MM 0394.13 Imp. J (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl- (A) 50 mg O O 5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9- propano-3aH-cyclopentacyclo-octen-8-yl Acetate O H (Mutilin 14-Acetate) HO O O MM 0394.18 Imp. P (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)-6- S (A) 50 mg O O Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo- O decahydro-3a,9-propano-3aH-cyclopentacyclo- O H octen-8-yl [(Phenylsulphonyl)oxy]acetate HO New MM 0394.23 Imp. E (EP) as Hydrogen Fumarate: (A) 50 mg (3aS,4R,6S,8R,9R,9aR,10R)-6- N O O Ethenyl-4,6,9,10-tetramethyl-1,5- S dioxodecahydro-3a,9-propano- O H 3aH-cyclopenta-cycloocten-8-yl [[2-(Diethylamino)ethyl]sulfanyl]- O acetate Hydrogen Fumarate x (11-Oxotiamulin Hydrogen Fumarate) O HO OH O Tiapride Hydrochloride MM 0073.01 Imp. C (EP): N,N-Diethylethane-1,2-diamine (B) 100 mg N H2N

MM 1331.04 N-[2-(Diethylamino)ethyl]-2-hydroxy- O O O (A) 100 mg S 5-(methylsulfonyl)benzamide N N H OH Ticlopidine Hydrochloride MM 0150.00 Ticlopidine Hydrochloride S (A) 500 mg N x HCl

Cl MM 0150.12 Imp. A (EP): Thieno[3,2-c]pyridine S (A) 100 mg N MM 0150.06 Imp. B (EP): 6,7-Dihydrothieno[3,2-c]pyridin-4(5H)-one S (A) 100 mg HN O

228 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0150.01 Imp. C (EP) as Hydrochloride: (2-Chloro- (A) 100 mg phenyl)methanamine Hydrochloride NH2 x HCl

Cl MM 0150.07 Imp. D (EP) as Hydrochloride: 5-Benzyl- S (A) 100 mg x HCl 4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N MM 0150.13 Imp. E (EP) as Chloride: 5-(2-Chlorobenzyl)- S (A) 50 mg thieno[3,2-c]pyridinium Chloride N+ Cl-

Cl MM 0150.14 Imp. F (EP) as Hydrochloride: 6-(2-Chloro- (A) 50 mg benzyl)-4,5,6,7-tetrahydrothieno[2,3-c]- N x HCl S pyridine Hydrochloride Cl MM 0150.08 Imp. G (EP) as Hydrochloride: 5-(3-Chlorobenzyl)- S (A) 100 mg x HCl 4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N Cl

MM 0150.09 Imp. H (EP) as Hydrochloride: 5-(4-Chlorobenzyl)- Cl S (C) 50 mg x HCl 4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N MM 0150.11 Imp. I (EP) as Hydrochloride: N-(2-Chlorobenzyl)- S (A) 100 mg 2-(thiophen-2-yl)ethanamine Hydrochloride NH x HCl

Cl MM 0150.10 Imp. J (EP) as Dihydrochloride: N,N'- N (A) 100 mg H Bis(2-chlorobenzyl)ethane-1,2-diamine NH x 2 HCl Dihydrochloride Cl Cl MM 0150.15 Imp. L (EP): 5-(2-Chlorobenzyl)-6,7-dihydrothieno S (A) 50 mg [3,2-c]pyridin-4(5H)-one N

Cl O MM 0150.04 5-(2-Chlorobenzoyl)-4,5,6,7-tetrahydrothieno S (A) 100 mg [3,2-c]pyridine N

Cl O Tilidine Hydrochloride Hemihydrate MM 0134.00 Tilidine Hydrochloride Hemihydrate (A) 100 mg N [Controlled Substance] x HCl x 1/2 H2O

OO and enantiomer MM 0134.01 Imp. A (EP): Ethyl (1RS,2RS)-2-(Dimethylamino)-1- (D) 100 mg N phenylcyclohex-3-enecarboxylate (cis-Tilidine) [Controlled Substance]

OO and enantiomer MM 0134.03 Imp. D (EP) as Hydrochloride: Ethyl (2RS)-3- (A) 100 mg N Dimethylamino-2-phenylpropanoate Hydrochloride x HCl O

O MM 0134.05 Tilidine [Controlled Substance] (A) 100 mg N

OO and enantiomer Timolol Maleate

OH O MM 0440.00 Timolol Maleate H (A) 250 mg N O N OH S x OH N N O O MM 0440.04 Imp. D (EP): 4-(Morpholin-4-yl)-1,2,5-thiadiazol-3-ol N OH (A) 100 mg S N N O MM 0440.03 N-Benzyl-tert-butylamine (B) 100 mg

HN

MM 0440.05 3-Hydroxy-4-morpholino-1,2,5-thiadiazole 1-Oxide N OH (A) 100 mg O S N N O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 229 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0440.02 (S)-Isotimolol (A) 100 mg HO N H N O S N N O Tinidazole MM 0012.02 Imp. A (EP): 2-Methyl-5-nitro-1H-imidazole O2 N (B) 100 mg (2-Methyl-4-nitroimidazole) NH N Tioconazole MM 0281.01 Imp. D (EP): (1RS)-1-(2,4-Dichlorophenyl)-2- Cl (A) 100 mg (1H-imidazol-1-yl)ethanol

Cl

HO N

N Tiotropium Bromide Monohydrate MM 1293.05 Imp. E (EP): Methyl 2-Hydroxy-2,2-dithiophen-2-ylacetate S O (A) 100 mg O S OH

MM 1293.06 Imp. F (EP): Dithiophen-2-ylmethanone S (A) 100 mg O S

Tizanidine Hydrochloride MM 0887.04 N-Acetyltizanidine N (A) 50 mg S Cl N N NH N

O MM 0887.05 1-Acetylimidazolidine-2-thione O (A) 50 mg N S N H Tocopheryl Acetate (all-rac-a-) New MM 1381.00 all-rac- -Tocopheryl Acetate (A) 250 mg O

O

O Tolazoline Hydrochloride

MM 0585.00 Tolazoline Hydrochloride N (A) 500 mg x HCl HN Tolbutamide New MM 1089.00 Tolbutamide O O O (A) 100 mg S NN HH

MM 0325.01 Imp. A (EP): (4-Methylphenyl)sulfonamide O O (C) 100 mg S (Toluenesulfonamide; 4-Methylbenzene- NH2

Tolnaftate MM 0731.01 Imp. A (EP): Naphthalen-2- -Naphthol) (A) 100 mg HO MM 0731.04 Imp. D (EP): N,3-Dimethylaniline (N-Methyl-m-toluidine) (A) 100 mg

NH

230 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit

MM 0731.03 O-Naphthalen-2-yl Chlorothioformate S (A) 100 mg

Cl O Tolmetin Sodium Dihydrate MM 0571.00 Tolmetin Sodium Dihydrate O on request N ONa x 2 H2O O Tolterodine Tartrate MM 0900.00 Tolterodine Tartrate (A) 100 mg OH O x HO OH N O OH OH Topiramate MM 1348.00 Topiramate O O (A) 100 mg S O ONH2O

O O O

Torasemide, Anhydrous MM 1283.02 Imp. B (EP): 4-[(3-Methylphenyl)amino]- O O (A) 100 mg S pyridine-3-Sulfonamide N NH2

NH

MM 1283.03 Imp. C (EP): 1-Ethyl-3-[[4-[(3-methylphenyl)amino]- O O O (A) 50 mg S pyridin-3-yl]sulfonyl]urea N NN HH NH

MM 1283.04 Imp. D (EP): 1-Butyl-3-[[4-[(3-methylphenyl)amino]- O O O (A) 50 mg S pyridin-3-yl]sulfonyl]urea N NN HH NH

New MM 1283.05 Imp. E (EP): Ethyl [[4-[(3-Methylphenyl)amino]pyridin- O O O (A) 100 mg S 3-yl]sulfonyl]carbamate N NO H NH

Tramadol Hydrochloride MM 0007.00 Tramadol Hydrochloride (A) 500 mg O OH x HCl N

and enantiomer MM 0007.01 Imp. A (EP) as Hydrochloride: (1RS,2SR)- (A) 100 mg O 2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)- OH x HCl cyclohexanol Hydrochloride N

and enantiomer MM 0007.03 Imp. B (EP) as Hydrochloride: O (A) 100 mg [2-(3-Methoxyphenyl)cyclohex-1-enyl]-N,N- dimethylmethanamine Hydrochloride x HCl N

MM 0007.04 Imp. C (EP) as Hydrochloride: (1RS)-[2-(3-Methoxy- O (A) 100 mg phenyl)cyclohex-2-enyl]-N,N-dimethylmethanamine Hydrochloride x HCl N

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Code Product Price Unit MM 0007.06 Imp. D (EP) as Hydrochloride: (1RS,2RS)-2- (A) 100 mg HO [(Dimethylamino)methyl]-1-(3-hydroxyphenyl)- OH x HCl cyclohexanol Hydrochloride N

and enantiomer MM 0007.02 Imp. E (EP) as Hydrochloride: (2RS)- O (A) 100 mg 2-[(Dimethylamino)methyl]- N x HCl cyclohexanone Hydrochloride

MM 0007.05 3-Bromoanisole O Br (B) 100 mg

MM 0007.07 N-Desmethyltramadol Hydrochloride (A) 100 mg O OH x HCl NH

and enantiomer MM 0007.08 N,O-Didesmethyltramadol Hydrochloride (A) 100 mg HO OH x HCl N H

and enantiomer MM 0007.09 3-Methoxyphenol O OH (B) 100 mg

MM 0007.11 Tramadol N-Oxide (A) 100 mg O OH N O

and enantiomer MM 0007.50 [2-(3-Hydroxyphenyl)cyclohex-1-enyl]-N,N- HO (A) 100 mg dimethylmethanamine Hydrochloride x HCl N

Tranexamic Acid MM 0330.00 Tranexamic Acid O (A) 500 mg OH H2 N

MM 0330.04 Imp. D (EP): 4-Aminomethylbenzoic Acid O (B) 100 mg OH H2 N Trazodone Hydrochloride MM 0421.00 Trazodone Hydrochloride (A) 100 mg

N N Cl N x HCl N N O MM 0421.13 Imp. A (BP) as Hydrochloride: (A) 50 mg 4-(3-Chloro-phenyl)-1-[3-(3-oxo-2,3- N N Cl dihydro-1,2,4-triazolo[4,3-a]pyridin-2- N x HCl N N yl)propyl]piperazine N1-oxide Hydrochloride (Trazodone N-Oxide Hydrochloride) O O

MM 0421.02 Imp. B (BP): 2-[3-(4-Phenylpiperazin-1-yl)- (A) 50 mg propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one N N N N N O MM 0421.03 Imp. C (BP) as Dihydrochloride: Cl on request 2-[3-[4-(4-Chlorophenyl)piperazin-1-yl]propyl]- 1,2,4-triazolo[4,3-a]pyridin-3(2H)-one N N x 2 HCl N Dihydrochloride N N O MM 0421.04 Imp. D (BP) as Hydrochloride: 2-3- (A) 50 mg [4-(3-Bromo-phenyl)piperazin-1-yl]- N N Br x HCl propyl-1,2,4-triazolo[4,3-a]-pyridin- N 3(2H)-one Hydrochloride N N O MM 0421.06 Imp. F (BP) as Hydrochloride: 1-(3-Chlorophenyl)- (A) 100 mg 4-(3-chloropropyl)piperazine Hydrochloride N Cl x HCl Cl N

232 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0421.07 Imp. G (BP) as Hydrochloride: 3-[4-(3- (D) 50 mg Chlorophenyl)piperazin-1-yl]propyl x HCl N Cl Isobutyl Ether Hydrochloride O N MM 0421.08 Imp. H (BP) as Dihydrochloride: 1,3-Bis-[4-(3-chloro- (A) 100 mg phenyl)piperazin-1-yl]propane Dihydrochloride Cl N N Cl N N x 2 HCl MM 0421.10 3-[4-(3-Chlorophenyl)piperazin-1-yl]propanol (A) 100 mg

N Cl HO N MM 0421.11 1,2,4-Triazolo-[4,3-a]pyridine-3(2H)-one (A) 100 mg N N NH O MM 0421.12 1,4-Bis-3-chlorophenylpiperazine on request N Cl Cl N

Trenbolone New MM 1377.00 OH (A) 100 mg

O Triacetin MM 0966.00 Triacetin O (A) 500 mg O O O

O O

OH MM 0198.01 Triamcinolone O (A) 250 mg

HO OH OH

F O MM 0198.02 Imp. A (EP): 9-Fluoro- -dihydroxy-3,20- O (A) 100 mg dioxopregna-1,4-diene- -diyl Diacetate O O (Triamcinolone 16,21-Diacetate) HO OH O

F O O OH MM 0508.03 Imp. C (EP): 9-Fluoro- -tetrahydroxypregn- O on request 4-ene-3,20-dione (Pretriamcinolone) HO OH OH

F O OH MM 0198.00 Triamcinolone Acetonide O (A) 250 mg

HO O O

F O OH MM 0198.01 Imp. A (EP): 9-Fluoro- -tetra- O (A) 250 mg hydroxypregna-1,4-diene-3,20-dione (Triamcinolone) HO OH OH

F O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 233 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0198.02 Triamcinolone 16,21-Diacetate O (A) 100 mg O O

HO OH O O F O OH MM 0198.05 Imp. C (Pharmeuropa): 9-Fluoro- - O (A) 100 mg trihydroxy- -(1-methylethylidenedioxy)- HO OH pregna-1,4-diene-3,20-dione (Triamcinolone O O Acetonide 21-Aldehyde Hydrate) F O Triamcinolone Hexacetonide MM 0306.00 Triamcinolone Hexacetonide O (A) 100 mg O O

HO O O

F O OH MM 0198.00 Imp. A (EP): Triamcinolone Acetonide O (A) 250 mg

HO O O

F O OH MM 0198.01 Triamcinolone O (A) 250 mg

HO OH OH

F O Triamterene

MM 0269.00 Triamterene H2 N N N NH2 (A) 500 mg N N NH2 MM 0269.02 Imp. A (EP): 5-Nitrosopyrimidine-2,4,6-triamine NH2 (B) 100 mg NO (Nitrosotriaminopyrimidine) N

H2N N NH2 MM 0269.01 Sodium Hydroxytriamterene Sulphate H2 N N N NH2 (B) 10 mg N O O N S NH2 NaO O Triazolam New MM 1363.00 Triazolam [Controlled Substance] N (A) 100 mg N N

Cl N

Cl

Tributyl Acetylcitrate

O O MM 0499.00 Tributyl Acetylcitrate O on request O O O O O O O MM 0499.01 Imp. A (EP): Tributyl 2-Hydroxypropane- O (C) 100 mg 1,2,3-tricarboxylate (Tributyl Citrate) HO O

O O O O MM 0499.02 Imp. B (EP) (E-Isomer): Tributyl (E)-Propene- O (A) 100 mg 1,2,3-tricarboxylate (Tributyl (E)-Aconitate) O

O O

234 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Triclabendazole MM 0313.00 Triclabendazole Cl (D) 100 mg H Cl O N S Cl N MM 0610.00 Triclosan Cl OH (A) 500 mg O

Cl Cl Trihexyphenidyl Hydrochloride MM 0237.00 Trihexyphenidyl Hydrochloride (A) 500 mg OH x HCl N

MM 0237.03 Imp. A (EP) as Hydrochloride: 1-Phenyl-3- O (A) 100 mg (piperidin-1-yl)propan-1-one Hydrochloride N x HCl

MM 0237.01 Acetophenone O (B) 100 mg

MM 0237.04 Trihexyphenidyl N-Oxide (C) 50 mg OH O N

Trimebutine MM 0417.00 Trimebutine O (A) 500 mg O O N O O

MM 0417.05 Trimebutine Maleate O O (A) 500 mg O O OH N x OH O O O MM 0417.01 Imp. A (EP) as Hydrochloride: (2RS)-2- (A) 100 mg N (Dimethylamino)-2-phenylbutanol Hydrochloride HO x HCl

MM 0093.13 Imp. B (EP): 3,4,5-Trimethoxybenzoic Acid O (B) 100 mg O OH

O O MM 0093.11 Imp. C (EP): Methyl 3,4,5-Trimethoxybenzoate O (A) 100 mg O O

O O

MM 0417.11 Imp. D (EP): (1RS)-1-[(Dimethylamino)-methyl]- N (A) 50 mg 1-phenylpropyl 3,4,5-Trimethoxybenzoate O O O

O O O MM 0417.07 Imp. E (EP) as Hydrochloride: (2RS)-2-(Methyl- H (A) 50 mg O N amino)-2-phenylbutyl 3,4,5-Trimethoxy-benzoate O Hydrochloride (N-Desmethyltrimebutine Hydro- x HCl chloride) O O HO MM 0417.10 1-Dimethylaminomethyl-1-phenyl-1-propanol N (A) 100 mg Hydrochloride (alpha-[(Dimethylamino)methyl]-alpha- x HCl ethyl-benzenemethanol Hydrochloride)

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 235 Table of content Pharmaceutical impurities

Code Product Price Unit Trimeprazine Tartrate MM 0958.00 Trimeprazine Tartrate (A) 500 mg N OH O x HO N OH O OH S 2 MM 0957.00 Trimeprazine Sulphone (Oxomemazine) (A) 100 mg N

N

S O O MM 0958.02 Trimeprazine Sulphoxide Hydrochloride (A) 100 mg N

N x HCl

S O MM 0958.04 Trimeprazine Sulphone N-Oxide Hydrochloride O (A) 100 mg N (Oxomemazine N-Oxide Hydrochloride) N x HCl

S O O Trimetazidine Dihydrochloride

MM 0539.00 Trimetazidine Dihydrochloride O (A) 100 mg O N x 2 HCl HN O MM 0539.01 Imp. A (EP) as Dihydrochloride: 1-(3,4,5- (A) 100 mg O Trimethoxybenzyl)piperazine Dihydrochloride N x 2 HCl HN O O

MM 0539.02 Imp. B (EP): 1,4-Bis(2,3,4-trimethoxy- O (A) 100 mg benzyl)piperazine O O N N O O O

MM 0539.03 Imp. C (EP): 2,3,4-Trimethoxybenzaldehyde O (B) 100 mg O O O

MM 0539.04 Imp. D (EP): (2,3,4-Trimethoxyphenyl)methanol O (A) 100 mg O HO O

MM 0539.05 Imp. E (EP) as Dihydrochloride: 1-(2,4,5- O (A) 100 mg Trimethoxybenzyl)piperazine Dihydrochloride N x 2 HCl HN O O

MM 0539.06 Imp. F (EP) as Dihydrochloride: 1-(2,4,6-Tri- O (A) 100 mg methoxybenzyl)piperazine Dihydrochloride N x 2 HCl HN O O

MM 0539.07 Imp. G (EP) as Hexahydrate: Piperazine Hexahydrate NH (B) 100 mg x 6 H2O HN

MM 0539.09 Imp. H (EP): Ethyl 4-(2,3,4-Trimethoxybenzyl)- O (A) 100 mg piperazine-1-carboxylate O N O N O O MM 0539.10 Imp. I (EP) as Dihydrochloride: 1-Methyl-4- O (A) 100 mg (2,3,4-trimethoxybenzyl)piperazine O x 2 HCl Dihydrochloride (N-Methyltrimetazidine N N Dihydrochloride) O

MM 0539.08 1-Formyl-4-(2,3,4-trimethoxybenzyl)piperazine O (A) 100 mg Hydrochloride O N x HCl O N O

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Code Product Price Unit Trimethoprim

MM 0093.00 Trimethoprim O (A) 500 mg O N NH2 N O NH2

MM 0093.06 Imp. A (EP): N 2-Methyl-5-(3,4,5-trimethoxybenzyl) O (A) 100 mg pyrimidine-2,4-diamine O N NH N O NH2

MM 0093.01 Imp. B (EP): (2,4-Diaminopyrimidin-5-yl)- O (A) 100 mg (3,4,5-trimethoxyphenyl)methanone O N NH2 N O O NH2

MM 0093.08 Imp. C (EP): (RS)-(2,4-Diaminopyrimidin-5-yl) O (A) 100 mg (3,4,5-trimethoxyphenyl)methanol O N NH2 N O OH NH2

MM 0093.04 Imp. D (EP): 2-Amino-5-(3,4,5-trimethoxybenzyl) O (A) 100 mg pyrimidin-4-ol O N NH2 N O OH

MM 0093.03 Imp. E (EP): 4-Amino-5-(3,4,5-trimethoxybenzyl) O (A) 100 mg pyrimidin-2-ol O N OH N O NH2

MM 0093.09 Imp. F (EP): 5-(3-Bromo-4,5-dimethoxybenzyl) O (A) 100 mg pyrimidine-2,4-diamine O N NH2 N Br NH2

MM 0093.10 Imp. G (EP): 5-(4-Ethoxy-3,5-dimethoxybenzyl) O (A) 100 mg pyrimidine-2,4-diamine O N NH2 N O NH2

MM 0093.11 Imp. H (EP): Methyl 3,4,5-Trimethoxybenzoate O (A) 100 mg O O O O

MM 0093.12 Imp. I (EP): 3-(Phenylamino)-2-(3,4,5-trimethoxy- O (A) 100 mg H benzyl)prop-2-enenitrile (E/Z-mixture) O N

O N

MM 0093.13 Imp. J (EP): 3,4,5-Trimethoxybenzoic Acid O (B) 100 mg O OH O O MM 0093.17 Imp. K (EP) as Hydrochloride: Aniline NH2 (B) 100 mg x HCl Hydrochloride

MM 0093.02 5-(3,4,5-Trimethoxybenzyl)pyrimidin-2,4-diol O (B) 10 mg O N OH N O OH

MM 0093.05 2-Amino-5-(4-hydroxy-3,5-dimethoxybenzyl) O (A) 100 mg pyrimidin-4-ol HO N NH2 N O OH

MM 0093.07 N4-Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine O (C) 50 mg -2,4-diamine O N NH2 N O NH Trimipramine Maleate

MM 0240.00 Trimipramine Maleate O (A) 500 mg

N N OH x OH

O

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 237 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0240.01 Trimipramine (A) 100 mg

N N

MM 0240.04 Imp. A (EP): (2RS)-3-(10,11-Dihydro-5H-dibenzo- (A) 100 mg [b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine N-oxide (Trimipramine N-Oxide) N N O

MM 0240.02 Imp. B (EP) as Hydrochloride: (2RS)-3-(10,11- (A) 100 mg Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,2-di- methylpropan-1-amine Hydrochloride N N x HCl H (Desmethyltrimipramine Hydrochloride)

MM 0240.05 Imp. C (EP) as Hydrochloride: (2RS)-3-(5H- (A) 50 mg Dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan- 1-amine Hydrochloride N N x HCl

MM 0077.00 Imp. D (EP) as Hydrochloride: Imipramine (A) 500 mg Hydrochloride N N x HCl

New MM 0240.07 Imp. E (EP): N-[3-(10,11-Dihydro-5H-dibenzo- (A) 50 mg [b,f]azepin-5-yl)-2-methylpropyl]-N,N',N',2- tetramethylpropane-1,3-diamine N N N

MM 0076.06 Imp. F (EP): 10,11-Dihydro-5H-dibenzo[b,f]azepine (B) 100 mg (Iminodibenzyl) NH

Tropicamide

MM 0601.00 Tropicamide O (A) 250 mg N N OH

MM 0601.01 Imp. A (EP): N-(Pyridin-4-ylmethyl)ethanamine HN (A) 100 mg N

MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid O (A) 100 mg (Tropic Acid) OH OH

MM 0160.03 Imp. D (EP): Phenylacetic Acid [Drug Precursor] O (B) 100 mg

OH Tropisetron Hydrochloride MM 0763.01 Imp. A (EP): (1R,3r,5S)-8-Methyl-8- H (A) 100 mg azabicyclo[3.2.1]oct-3-ol (Tropine) H N HO H MM 0763.02 Imp. B (EP): 1H-Indole-3-carboxylic Acid O (A) 100 mg OH HN

Trospium Chloride

MM 0783.09 Imp. A (EP): Hydroxydiphenylacetic Acid O (B) 100 mg (Benzilic Acid) OH OH

238 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Tryptophan

H MM 0172.00 L-Tryptophan N (A) 500 mg NH 2 OH

O MM 0172.09 Imp. A (EP): 3,3'-[Ethylidenebis(1H-indole- (D) 100 mg 1,3-diyl)]bis[(2S)-2-aminopropanoic] Acid (1,1'-Ethylidenebistryptophan) N N NH2 HO OH NH2 O O MM 0172.03 Imp. D (EP): (S)-2-Amino-3-(5-hydroxy-1H-indol-3-yl) H (A) 100 mg N propanoic Acid (5-Hydroxytryptophan) NH2 OH

O HO MM 0172.13 N-Acetyltryptophan O (A) 100 mg H N HN OH

O Tyrosine

HO MM 0634.00 Tyrosine NH2 (A) 100 mg OH

O Valaciclovir Hydrochloride, Anhydrous MM 0061.02 Imp. A (EP): 2-Amino-1,9-dihydro-6H-purin-6-one O (B) 100 mg N (Guanine) HN

H2N N N H MM 0061.00 Imp. B (EP): 2-Amino-9-[(2-hydroxy-ethoxy)methyl]- O (A) 500 mg N 1,9-dihydro-6H-purin-6-one (Aciclovir) HN N OH H2N N O MM 0619.07 Imp. G (EP): N,N-Dimethylpyridin-4-amine N (A) 100 mg

N

MM 0061.01 Imp. I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- O (A) 100 mg N 9H-purin-9-yl)methoxy]ethyl Acetate HN

N O H2N N O O Valproic Acid MM 0751.00 Valproic Acid O (A) 500 mg OH

MM 0751.11 Sodium O (A) 500 mg ONa

MM 0751.01 Imp. A (EP): Pentanoic Acid () O (C) 100 mg OH MM 0751.02 Imp. B (EP): (2RS)-2-Ethylpentanoic Acid O (A) 100 mg OH

MM 0751.03 Imp. C (EP): (2RS)-2-(1-Methylethyl)pentanoic Acid O (A) 100 mg OH

MM 0751.04 Imp. D (EP): 2,2-Dipropylpentanoic Acid O (A) 100 mg OH

MM 0751.05 Imp. E (EP): Pentanamide (Valeramide) O (A) 100 mg NH2

Edition 2012/2013 All your needs for pharmaceutical analysis – email [email protected] 239 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0751.06 Imp. F (EP): 2-Propylpentanamide O (A) 100 mg NH2

MM 0751.07 Imp. G (EP): 2,2-Dipropylpentanamide O (A) 100 mg NH2

MM 0751.08 Imp. H (EP): Pentanenitrile (Valeronitrile) N (C) 100 mg

MM 0751.09 Imp. I (EP): 2-Propylpentanenitrile N (A) 100 mg

MM 0751.10 Imp. J (EP): 2,2-Dipropylpentanenitrile N (A) 100 mg

Valsartan

O OH New MM 0487.04 Imp. C (EP): (2S)-2-[Butanoyl[[2'-(1H-tetrazol-5- N N (A) 50 mg yl)biphenyl-4-yl]methyl]amino]-3-methylbutanoic HN N Acid N O

Vancomycin Hydrochloride

MM 0239.00 Vancomycin Hydrochloride NH 2 (A) 100 mg HO OH NH H O Cl O N HO O OH O HN O O O O HO NH O O NH 2 Cl x HCl HN O O NH HO O OH OH OH O N H

OH Venlafaxine Hydrochloride MM 0393.00 Venlafaxine Hydrochloride (D) 100 mg OH x HCl N

O MM 0393.02 Imp. A (EP) as Hydrochloride: 2-(4- (A) 100 mg N Methoxyphenyl)-N,N-dimethylethanamine x HCl Hydrochloride O MM 0393.07 Imp. B (EP) as Hydrochloride: Ethyl (2RS)-3- (A) 100 mg (Dimethylamino)-2-(4-methoxyphenyl)propanoate O O Hydrochloride x HCl N

O MM 0393.08 Imp. C (EP) as Hydrochloride: 1-[(1RS)-2-Amino- (A) 100 mg OH 1-(4-methoxyphenyl)ethyl]cyclohexanol Hydrochloride x HCl NH2

O MM 0393.04 Imp. D (EP) as Hydrochloride: 1-[(1RS)-1-(4- (A) 100 mg OH Methoxyphenyl)-2-(methylamino)ethyl]cyclo- H x HCl hexanol Hydrochloride N

O MM 0393.09 Imp. E (EP) as Hydrochloride: (5RS)-5-(4- (A) 100 mg O Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro- x HCl [5.5]undecane Hydrochloride N

O

240 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit MM 0393.10 Imp. F (EP) as Hydrochloride: (2RS)-2- (A) 100 mg (Cyclohex-1-enyl)-2-(4-methoxyphenyl)- N,N-dimethylethanamine Hydrochloride x HCl N

O MM 0393.03 Imp. G (EP) as Hydrochloride: (2RS)-2- (A) 100 mg Cyclohexyl-2-(4-methoxyphenyl)-N,N- dimethylethanamine Hydrochloride x HCl N

O MM 0393.11 Imp. H (EP): 1-[(1RS)-1-(4-Methoxyphenyl)- (A) 50 mg OH 2-[[2-(4-methoxyphenyl)ethyl]amino]ethyl]- H Cyclohexanol N

O O MM 0393.01 O-Desmethylvenlafaxine (A) 100 mg OH

N

HO Verapamil Hydrochloride

MM 0022.00 Verapamil Hydrochloride O (A) 500 mg O O

O N

x HCl N MM 0022.07 Imp. A (EP) as Dihydrochloride: N,N'- O x 2 HCl O (A) 100 mg Bis[2-(3,4-dimethoxyphenyl)ethyl]- N,N'-dimethylpropane-1,3-diamine O N N O Dihydrochloride

MM 0022.08 Imp. B (EP) as Hydrochloride: 2- O (A) 100 mg (3,4-Dimethoxyphenyl)-N-methylethanamine Hydrochloride x HCl O NH

MM 0022.09 Imp. C (EP) as Hydrochloride: 2-(3,4- O (A) 100 mg Dimethoxyphenyl)-N,N-dimethylethan- x HCl amine Hydrochloride O N

MM 0022.02 Imp. D (EP): 3-Chloro-N-[2- O (A) 100 mg (3,4-dimethoxyphenyl)ethyl]-N-methylpropan-1-amine O N Cl

MM 0022.05 Imp. E (EP): (3,4-Dimethoxyphenyl)methanol O (B) 100 mg OH O MM 0022.10 Imp. F (EP) as Hydrochloride: (2RS)- O (A) 100 mg 2-(3,4-Dimethoxyphenyl)-5-(methylamino)- O 2-(1-methylethyl)pentanenitrile Hydrochloride x HCl HN

N MM 0022.04 Imp. G (EP): 3,4-Dimethoxybenzaldehyde O (B) 100 mg O

O MM 0022.11 Imp. H (EP) as Hydrochloride: (2RS)- O (A) 100 mg 2-(3,4-Dimethoxyphenyl)- O x HCl O 5-[[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]- 2-ethylpentanenitrile Hydrochloride O N

N MM 0022.12 Imp. I (EP) as Hydrochloride: (2RS)- O N (A) 50 mg 2-(3,4-Dimethoxyphenyl)-2-[2-[[2-(3,4-dimethoxy- O phenyl)ethyl](methyl)amino]ethyl]-3-methyl- O N butanenitrile Hydrochloride x HCl O

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Code Product Price Unit MM 0022.21 Imp. J (EP) as Maleate: (2RS)- O (A) 100 mg 2-(3,4-Dimethoxyphenyl)- OH 5-[[2-(3,4-dimethoxyphenyl)ethyl]amino]- x OH 2-(1-methylethyl)pentanenitrile Maleate O (N-Norverapamil Maleate) O O O

O N H N MM 0022.03 Imp. K (EP): (2RS)-2-(3,4-Dimethoxyphenyl)- O (A) 100 mg 3-methylbutylnitrile O

N MM 0022.13 Imp. L (EP): 1-(3,4-Dimethoxyphenyl)-2- O (A) 100 mg methylpropan-1-one O

O MM 0022.15 Imp. N (EP) as Hydrochloride: 5,5'- O O (A) 50 mg x HCl (Methylimino)bis[2-(3,4-dimethoxy- O O phenyl)-2-(1-methylethyl)pentanenitrile] Hydrochloride N

N N MM 0022.16 Imp. O (EP) as Hydrochloride: (2RS)- O (A) 100 mg 2-(3,4-Dimethoxyphenyl)- O x HCl O 5-[2-[2-(3,4-dimethoxy- phenyl)ethyl](methyl)amino]- O N 2-propylpentanenitrile Hydrochloride N

MM 0022.06 Diisopropylhomoveratylcyanide O (D) 100 mg O N

MM 0022.18 3,4-Dimethoxyphenylacetonitrile O (A) 100 mg O

N MM 0022.19 Verapamil N-Oxide Hydrochloride O (C) 50 mg O O O O N

x HCl N Vincamine MM 0519.00 Vincamine (A) 100 mg H N N HO O O Vinpocetine MM 0406.00 Vinpocetine O (D) 100 mg O N N H

MM 0406.02 Imp. A (EP): Ethyl (12RS,13aSR,13bSR)-13a- O (D) 100 mg Ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octa- O hydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]- HO N naphthyridine-12-carboxylate (Ethyl Vincaminate) N H

and enantiomer MM 0406.01 Imp. B (EP): Methyl (13aS,13bS)-13a-Ethyl- O (D) 100 mg 2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1- O de]pyrido[3,2,1-ij][1,5]naphthyridine-12- N carboxylate (Apovincamine) N H

242 All your needs for pharmaceutical analysis – email [email protected] Edition 2012/2013 Table of content Pharmaceutical impurities

Code Product Price Unit Voriconazole MM 1094.04 Imp. A (EP): 1-(2,4-Difluorophenyl)-2- F (A) 100 mg (1H-1,2,4-triazol-1-yl)ethanone

F

O N N N Warfarin New MM 0638.00 Warfarin O O (A) 100 mg

OH

O Warfarin Sodium MM 0732.01 Imp. A (EP): (5RS)-3-(2-Hydroxyphenyl)-5-phenylcyclohex- OH (A) 100 mg 2-enone

O MM 0732.02 Imp. B (EP): 4-Hydroxy-2H-1-benzopyran- O O (A) 100 mg 2-one (4-Hydroxycoumarin)

OH MM 0732.03 Imp. C (EP): (3E)-4-Phenylbut-3-en-2-one (A) 100 mg (Benzalacetone)

O Xylazine Hydrochloride

MM 0515.00 Xylazine Hydrochloride H (A) 500 mg S N x HCl N MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline (2,6-Xylidine) (B) 100 mg H2N

Xylometazoline Hydrochloride MM 0089.00 Xylometazoline Hydrochloride (A) 500 mg N x HCl N H MM 0089.07 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2- (A) 100 mg [4-(1,1-dimethylethyl)-2,6-dimethylphenyl]acetamide O x HCl Hydrochloride NH2 N H MM 0089.04 Imp. B (EP): 2-(Chloromethyl)-5-(1,1-dimethylethyl)- (A) 100 mg 1,3-dimethylbenzene Cl

MM 0089.03 Imp. C (EP): [4-(1,1-Dimethylethyl)-2,6- (A) 100 mg dimethylphenyl]acetonitrile N

MM 0089.05 Imp. D (EP): 1-(1,1-Dimethylethyl)-3,5- (C) 100 mg dimethylbenzene

MM 0089.02 Imp. F (EP): [4-(1,1-Dimethylethyl)-2,6- (A) 100 mg dimethylphenyl]acetic Acid O OH

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Code Product Price Unit Zaleplon New MM 1322.00 Zaleplon (A) 100 mg N

O

N N

N

N MM 1322.02 N-[3-[3-(Dimethylamino)-1-oxo-2-propenyl]phenyl]- (A) 100 mg N-ethylacetamide N

O

O

N

Zidovudine MM 0534.00 Imp. A (EP): 1-[(2R,5S)-5-(Hydroxymethyl)-2,5- O (A) 100 mg dihydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione HN (Stavudine) HO O N O

MM 0173.02 Imp. B (EP): 1-(3-Chloro-2,3-dideoxy- -D- O (A) 100 mg erythro-pentofuranosyl)-5-methylpyrimidine- HN 2,4(1H,3H)-dione HO O N O

Cl MM 0534.01 Imp. C (EP): 5-Methylpyrimidine-2,4(1H,3H)dione O (A) 100 mg (Thymine) HN

O N H MM 0173.04 Imp. D (EP): Triphenylmethanol (A) 100 mg OH

MM 0534.03 Thymidine O (A) 100 mg HN HO O N O

OH Zileuton New MM 1297.01 N-(1-Benzo-[b]thien-2-ylethyl)urea NH2 (A) 50 mg HN O S MM 1297.02 2-(Benzo[b]thien-2-oyl)benzo[b]thiophene O (A) 50 mg

S S

MM 1297.03 1-Benzo-[b]thien-2-ylethanone O (A) 100 mg S Ziprasidone Hydrochloride Monohydrate MM 1273.00 Ziprasidone Hydrochloride Monohydrate O (A) 100 mg x HCl x H2O HN

N Cl N

N S

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Code Product Price Unit Zolpidem Tartrate New MM 0333.11 Zolpidem Tartrate [Controlled Substance] (A) 100 mg OH O N x HO O OH N O OH N 2 MM 0333.01 Imp. A (EP): N,N-Dimethyl-2-[7-methyl- (D) 100 mg 2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl] N acetamide O N N

MM 0333.02 2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl] (A) 100 mg acetamide N O N NH2

MM 0333.03 2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl] (A) 100 mg acetic Acid N O N OH

MM 0333.04 Methyl 2-[6-Methyl-2-(4-methylphenyl)imidazo[1,2-a] (D) 50 mg pyridin-3-yl]acetate N O N O

MM 0333.05 6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridine- (A) 100 mg 3-acetonitrile N

N N

MM 0333.06 Oxozolpidem (N,N,6-Trimethyl-2-(4-methylphenyl)- - (D) 100 mg oxo-imidazo [1,2-a]pyridine-3-acetamide) N O N N O MM 0333.07 Zolpaldehyde (6-Methyl-2-(4-methylphenyl)-imidazo[1,2-a] (A) 100 mg pyridine-3-carboxaldehyde) N

N O

MM 0333.08 Zolpyridine (4-Methyl-N-(5-methyl-2-pyridinyl)-benzamide) (A) 100 mg H N N O MM 0333.09 6-Methyl-2-(4-methylphenyl)- -oxo-imidazo[1,2- (A) 100 mg a]pyridine-3-acetamide N O N NH2 O MM 0333.10 Methyl  (A) 100 mg imidazo[1,2-a]pyridine-3-acetate N O N O HO Zonisamide New MM 1379.00 Zonisamide O O (A) 100 mg S NH2

N O Zopiclone MM 0149.00 Zopiclone O (D) 100 mg Cl N O N N N N O N

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Code Product Price Unit MM 0149.01 Imp. A (EP): (5RS)-6-(5-Chloropyridin-2-yl)-7-oxo- O (D) 100 mg Cl 6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4- N O Methylpiperazine-1-carboxylate 4-Oxide O N N N (Zopiclone Oxide) N O N MM 0149.02 Imp. B (EP): (7RS)-6-(5-Chloropyridin-2-yl)-7- Cl (D) 100 mg HO hydroxy-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one N N N O N MM 0149.03 Imp. C (EP): 6-(5-Chloropyridin-2-yl)-6,7- Cl (A) 50 mg dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one N N N O N MM 0149.04 2-Amino-5-chloropyridine Cl (A) 250 mg

H2N N Cl MM 0149.05 3-(5-Chloropyridine-2-carbamoyl)-2-pyrazinecarboxylic Acid O (A) 100 mg N N N H N OH O MM 0149.06 6-(5-Chloropyridin-2-yl)- 6,7-dihydro-5H-pyrrolo[3,4-b] Cl (A) 100 mg O pyrazin-5,7-dione N N N O N Cl MM 0149.07 5-(Chloropyridine-2-yl-carbamoyl)pyrazine O (A) 100 mg N N N H N Cl MM 0149.50 2-Acetylamino-5-chloropyridine O (A) 100 mg

N N H

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