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API IMPURITIES TO OFFER FOR EXPORT And DOMESTIC MARKET

API IMPURITIES PRODUCTS LIST

Impurity Name CAS No. Product Name

1,6- Dibromohexane 629-03-8 1, 6- Dibromohexane

(1S,4R)-4-[2-Amino-6-(Cyclopropylamino)-9H-Purin-9-Yl]-2- 136470-78-5 Abacavir Cyclopentene-1-

Avermectin B1; MK-936; Agri-Mek; Avid; Zephyr; 71751-41-2 Abamectin

(1R,4aR,4bR,10aR)-1,2,3,4,4a,4b,5,6,10,10a-Decahydro-1,4a- Dimethyl-7-(1-Methylethyl)-1-Phenanthrenecarboxylic 514-10-3 Abietic Acid Acid;

(3β)-17-(3-Pyridinyl)Androsta-5,16-Dien-3-Ol 154229-18-2 Acetate (); CB 7630;

2-(4-Methoxyphenyl)-5, 7-Dihydroxy-4H-1-Benzopyran-4-One; 480-44-4 Acacetin 4’-O-Methylapigenin;

5-Aminoimidazole-4-Carboxamide-1-Β-D-Ribofuranoside; 2627-69-2 Acadesine

O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6 -Trihydroxy-3-(Hydroxymethyl)-2-Cyclohexen-1-Yl] 56180-94-0 Acarbose Amino]-Α-D-Glucopyranosyl-(1→4)-O-Α-D -Glucopyranosyl-(1→4)-D-Glucose;

1

Ambroxol Theophylline-7-Acetic Acid; 179118-73-1 Acebrophylline

N-[3-Acetyl-4-[2-Hydroxy-3-[(1-Methylethyl)Amino] 34381-68-5 Acebutolol Hydrochloride Propoxy]Phenyl]Butanamide Hydrochloride;

Aceclofenac Impurity F (EP) 100499-89-6

Aceclofenac Aceclofenac (WS); 2-[(2,6-Dichlorophenyl)-Amino] 89796-99-6 Benzeneacetic Acid Carboxymethyl Ester;

4-(Acetylamino)Benzoic Acid; 4-Acetamidobenzoic Acid 556-08-1 Acedoben

Theophylline-7-Acetic Acid; 1,2,3,6-Tetrahydro-1,3-Dimethyl 652-37-9 Acephylline -2,6-Dioxo-7H-Purine-7-Acetic Acid;

Ethanimidamide Hydrochloride; 124-42-5 Acetamidine Hydrochloride

N-(4-Hydroxyphenyl)Acetamide; 103-90-2 Acetaminophen

N-[5-Aminosulfonyl)-1,3,4-Thiadiazol-2-Yl]Acetamide; 59-66-5 Acetazolamide

N-Hydroxyacetamide; Ethanehydroxamic Acid; AHA; Acetic Acid Oxime; Acetohydroximic Acid; 546-88-3 Acetohydroxamic Acid Acetylhydroxamic Acid;

N-Acetyl-L-Cysteine; ACC; Acetadote; 616-91-1 Acetylcysteine

2-Acetoxybenzoic Acid; 2-(Acetyloxy)Benzoic Acid; 50-78-2 Acetylsalicylic acid Acylpyrin; Angettes; Aspro; Aspirin; ASA;

10-Azaanthracene; 2,3-Benzoquinoline; 260-94-6 Acridine

2

2-Amino-1, 59277-89-3 Acyclovir 9-Dihydro-9-[(2-Hydroxyethoxy)Methyl]-6H-Purin-6-One;

Tricyclo[3.3.1.1(3,7)]Decan-1-Amine; 1-Adamantanamine; Adamantamine; Adamantanamine; 768-94-5 Adamantamine Adamantylamine;

6-(4-Methoxy-3-Tricyclo[3.3.1.13,7]Dec-1-Ylphenyl)- 106685-40-9 Adapalene 2-Naphthalenecarboxylic Acid;

P’-[[2-(6-Amino-9H-Purin-9-Yl)Ethoxy]Methyl] Adefovir Phosphate - Isohypophosphoric Acid Triethylamine Salt; Triethylamine

9-Β-D-Ribofuranosyl-9H-Purin-6-Amine; 58-61-7 Adenosine

(6S,7S)-7-[(Hydroxyamino)Carbonyl]-6- [(4-Phenyl-1-Piperazinyl)Carbonyl]-5-Azaspiro[2.5] 791828-58-5 Aderbasib Octane-5-Carboxylic Acid Methyl Ester; INCB 007839;

Α-Phenylbenzeneacetic Acid 2-(Diethylamino)Ethyl Ester 50-42-0 Adiphenine Hydrochloride Hydrochloride

(−)-Epinephrine (+)-Bitartrate Salt; L-3,4-Dihydroxy-Α-(Methylaminomethyl)Benzyl 51-42-3 Adrenaline Tartrate D-Hydrogen Bitartrate Salt;

Escin; Aescin; Chestnuts Extract; 11072-93-8 Aescin

Aflatoxin B1; (6aR,9aS)-2,3,6a,9a-Tetrahydro- 4-Methoxy-1H,11H-Cyclopenta[C]Furo[3’,2’:4,5] 1162-65-8 Aflatoxin Furo[2,3-H][1]Benzopyran-1,11-Dione;

6-Amino-2-(Fluoromethyl)-3-(2-Methylphenyl)- 56287-74-2 Quinazolin-4-One

3

N-[2-(7-Methoxy-1-Naphthalenyl)Ethyl]Acetamide; N-[2-(7-Methoxy-1-Naphthyl) Ethyl]Acetamide; 138112-76-2 Agomelatine S 20098; Valdoxan;

DL-Alanine; (R,S)-Alanine; 302-72-7 Alanine

N-[6-(Propylthio)-1H-Benzimidazol-2-Yl]Carbamic Acid Methyl Ester; [5-(Propylthio)-1H-Benzimidazol-2-Yl] 54965-21-8 Albendazole Carbamic Acid Methyl Ester; Albenza; Andazol;

Salbutamol Sulphate; Α1-[[(1,1-Dimethylethyl)Amino]Methyl] 51022-70-9 Albuterol Sulfate -4-Hydroxy-1,3-Benzenedimethanol Sulfate; Aerolin;

6,11-Dihydro-11-(1-Methyl-4-Piperidinylidene)- 5H-Imidazo[2,1-B][3]Benzazepine-3-Carboxaldehyde; 147084-10-4 Alcaftadine R 89674

(11β)-11,21-Dihydroxy-3,20-Dioxopregn-4-En-18-Al; 52-39-1

N-[3-[(4-Amino-6,7-Dimethoxy-2-Quinazolynyl) 81403-68-1 Alfuzosin Hydrochloride Methylamino]Propyl]Tetrahydro-2-Furancarboxamide;

5,5-Diallybarbituric Acid; 5,5-Di-2-Propenyl-2,4,6 52-43-7 (1H,3H,5H)Pyrimidinetrione; Allobarbitone

1,5-Dihydro-4H-Pyrazolo[3,4-D]Pyrimidin-4-One; 1H-Pyrazolo(3,4-D)Pyrimidin-4-Ol; 315-30-0 Allopurinol 4-Hydroxypyrazolo(3,4-D)Pyrimidine; 4-Hydroxypyrazolo[3,4-D]Pyrimidine; HPP

8-Chloro-1-Methyl-6-Phenyl-4H-[1,2,4] Triazolo[4,3-A][1,4]; 28981-97-7 8-Chloro-1-Methyl-6-Phenyl-4H-S-Triazolo[4,3-A][1,4] Benzodiazepine; Tensivan; Trankimazin; Tranquinal;

4

Tricalma; U 31889; Valeans; Xanagis; Xanax; Xanax TS; Xanolam; Xanor; Zolam; Zo

N-Ethyl-N-(3-Phenylpropyl)Benzenepropanamine 5560-59-8 Alverine Citrate 2-Hydroxy-1,2,3- Propanetricarboxylate;

Tricyclo[3.3.1.13,7]Decan-1-Amine Hydrochloride 665-66-7 Amantadine Hydrochloride

4-[[(2-Amino-3,5-Dibromophenyl)Methyl]Amino] 23828-92-4 Ambroxol Hydrochloride Cycophexanol Hydrochloride;

N-Amidino-3,5-Diamino-6-Chloropyrazinecarboxamide Amiloride Hydrochloride 17440-83-4 Hydrochloride Dihydrate; Dihydrate

(2-Butyl-3-Benzofuranyl)[4-[2-(Diethylamino)Ethoxy] 19774-82-4 Amiodarone Hydrochloride -3,5-Diiodophenyl]Methanone Hydrochloride;

4-Amino-N-[(1-Ethyl-2-Pyrrolidinyl)Methyl]-5- (Ethylsulfonyl)-2-Methoxybenzamide; Aminosultopride; 71675-85-9 Amisulpride DAN-2163; Socian; Solian; Sulamid;

N’-(2,4-Dimethylphenyl)-N-[[(2,4-Dimethylphenyl)Imino] 33089-61-1 Amitraz Methyl]-N-Methyl-Methanimidamide;

3-(10,11-Dihydro-5H-Dibenzo[A,D]Cyclohepten-5-Ylidene) 549-18-8 Amitriptyline Hydrochloride -N,N-Dimethyl-1-Propanamine Hydrochloride

Amlodipine EP Impurity I, Amlodipine Besilate - 2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-1,4 111470-99-6 -Dihydro-6-Methyl-3,5-Pyridinedicarboxylic Acid Amlodipine 3-Ethyl 5-Methyl Ester Benzenesulfonate;

Amlodipine Impurity D (EP) 113994-41-5

5

2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-3- Ethoxycarbonyl-5-Methoxycarbonyl)-6-Methyl-1,4 88150-42-9 -Dihydropyridine;

Amlodipine EP Impurity G 43067-01-2

Amlodipine Maleate - Diethyl 2-((2-Aminoethoxy)Methyl)-4-(2-Chlorophenyl) 1357024-06-6 -6-Methyl-1,4-Dihydropyridine-3,5-Dicarboxylate Maleate;

Amlodipine Mesilate; 246852-12-0

4-[(7-Chloro-4-Quinolinyl)Amino]-2-[(Diethylamino)Methyl] Amodiaquine 6398-98-7 Dihydrochloride; Dihydrochloride Dihydrate

5-Amino-2-[2-(Dimethylamino)Ethyl]-1H-Benz[De] 69408-81-7 Amonafide Isoquinoline-1,3(2H)-Dione;

Amoxicillin; (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-Hydroxyphenyl)Acetyl] 61336-70-7 Amoxicillin Trihydrate Amino]-3,3-Dimethyl-7-Oxo-4-Thia-1-Azabicyclo[3.2.0] Heptane-2-Carboxylic Acid;

Ampicillin Sodium - D-(-)-6-(2-Amino-2-Phenylacetamido)-3,3-Dimethyl -7-Oxo-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 69-52-3 Acid Monosodium Salt; Binotal Sodium; Britapen ; Cilleral; D-Α-Aminobenzylpenicillin Sodium Salt; Ampicillin Ampicillin Sodium Salt; Ampicillin-Na; Ampicin

Ampicillin Trihydrate - D-(−)-Α-Aminobenzylpenicillin; 7177-48-2

Anastrozole Impurity E 1027160-12-8 Anastrozole

6

Anastrozole Impurity 120511-73-1

Anastrozole Impurity D 120511-84-4

Anastrozole Impurity B 1215780-15-6

Anastrozole Impurity C 1216898-82-6

(5α,17β)-17-Hydroxyandrostan-3-One; 521-18-6 Androstanolone ; 5α-Dihydrotestosterone; Stanolone;

3α-Hydroxy-5α-Androstan-17-One, 53-41-8 5α-Androstan-3α-Ol-17-One;

1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(Pentyloxy) [1,1':4',1"-Terphenyl]-4-Yl]Carbonyl]-L-Ornithine] 166663-25-8 Anidulafungin Echinocandin B; Ecalta; Eraxis; LY 303366;

Antazoline Hydrochloride - 4,5-Dihydro-N-Phenyl-N- (Phenylmethyl)-1H--2-Methanamine 2508-72-7 Hydrochloride 4,5-Dihydro-N-Phenyl-N-(Phenylmethyl) -1H-Imidazole-2-Methanamine Monohydrochloride Antazoline

Antazoline Phosphate - Antistine Phosphate; 154-68-7 2-[(N-Benzylanilino)Methyl]-2-Imidazoline Phosphate;

5,7-Dihydroxy-2-(4-Hydroxyphenyl)-4H-1- Benzopyran-4-One; 4’,5,7-Trihydroxyflavone; 520-36-5 Pelargidenon 1449

(6aR)-5,6,6a,7-Tetrahydro-6-Methyl-4H-Dibenzo[De,G] Apomorphine 41372-20-7 Quinoline-10,11-Diol Hydrochloride Hemihydrate Hydrochloride Hemihydrate

7

N1-(2,3-Dihydro-1H-Inden-2-Yl)-N3,N3-Diethyl-N1- 33237-74-0 Aprindine Hydrochloride Phenyl-1,3-Propanediamine Hydrochloride;

(5Z,8Z,11Z,14Z)-5,8,11,14-Eicosatetraenoic Acid; 506-32-1 Arachidonic Acid

1,2,5,6-Tetrahydro-1-Methyl-3-Pyridinecarboxylic 300-08-3 Arecoline Hydrobromide Acid Methyl Ester Hydrobromide;

(2R,4R)1-[(2S)2-Amino-5-[[Imino(Nitroamino)Methyl] Amino]-1-Oxopentyl]-4-Methyl-2-Piperidinecarboxylic 74874-08-1 Argatroban Acid Ethyl Ester Hydrochloride; Argatroban Intermediate;

Arginine - L-Arginine; Arginine; Argivene; Detoxargin; 74-79-3 L-(+)-Arginine; Arginine Arginine Hydrochloride - L-Arginine Hydrochloride; 1119-34-2 L-Arginine Monohydrochloride;

Argirelin Acetate(Acetyl Hexapeptide-3); 616204-22-9 Argireline Acetate

Aripiprazole Impurity D 882880-12-8

Aripiprazole Impurity E 120004-79-7 Aripiprazole

Aripiprazole - 7-[4-[4-(2,3-Dichlorophenyl)-1-Piperazinyl] 129722-12-9 Butoxy]-3,4-Dihydro-2(1H)-Quinolinone;

8-Methoxybenzo[F]-1,3-Benzodioxolo[6,5,4-Cd]Indol- 13395-02-3 Aristolactam 5(6H)-One; Aristolactam

Butanedioic Acid 88495-63-0 Artesunate Mono(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-3,6

8

,9-Trimethyl-3,12-Epoxy-12H-Pyrano[4,3-J]-1,2- Benzodioxepin-10-Yl] Ester; Artesunic Acid

Carticaine Hydrochloride; 4-Methyl-3-[2-(Propylamino) Propionamido]-2-Thiophenecarboxylic Acid Methyl 23964-57-0 Articaine Hydrochloride Ester Hydrochloride;

Changchuanmycin; Immunomycin; FK 520; FR 520; 104987-12-4 Ascomycin FR 900520; L 683590;

L-Ascorbic Acid; (+)-Ascorbic Acid; 100M; 50-81-7 Ascorbic Acid L-Threo-Ascorbic Acid;

Asenapine N-oxide Impurity 128949-51-9

Asenapine (3aR,12bR)-Rel-5-Chloro-2,3,3a,12b-Tetrahydro-2- 65576-45-6 Methyl-1H-Dibenz[2,3:6,7]Oxepino[4,5-C]Pyrrole;

L-Α-Aspartyl-L-Phenylalanine 2-Methyl Ester; Canderel; 22839-47-0 Aspartame

(S)-(+)-Aminosuccinic Acid; (S)-Aminobutanedioic Acid; 56-84-8 Aspartic acid L-Aspartic Acid;

Aspirin Impurity - A,D,F,C 99-96-7 Aspirin Aspirin Impurity A (EP) 99-96-7

1-[(4-Fluorophenyl)Methyl]-N-[1-[2-(4-Methoxyphenyl) 68844-77-9 Astemizole Ethyl]-4-Piperidinyl]-1H-Benzimidazol-2-Amine;

Atenolol Impurity C 29122-69-8 Atenolol

9

Atenolol Impurity - H,F 87619-83-8

4-[2-Hydroxy-3-[(1-Methylethyl)Amino]Propoxyl] 29122-68-7 Benzeneacetamide;

Atorvastatin methyl ester 345891-62-5

Atorvastatin ethyl ester 1146977-93-6

Atorvastatin Impurity H (EP) 125995-03-1 Atorvastatin

Atorvastatin Lactone 125995-03-1

Atorvastatin Acid - (3R,5R)-2-(4-Fluorophenyl)-3,5-Dihydroxy-5- 134523-00-5 (1-Methylethyl)-3-Phenyl-4-[(Phenylamino)Carbonyl] -1H-Pyrrole-1-Heptanoic Acid ;

Atovaquone methyl 129700-41-0 Atovaquone methyl ether

2,2’-[1,5-Pentanediylbis[Oxy(3-Oxo-3,1-Propanediyl)]] Bis[1-[(3,4-Dimethoxyphenyl)Methyl]-1,2,3,4-Tetrahydro- 64228-81-5 Atracurium Besylate 6,7-Dimethoxy-2-Methyl-Isoquinolinium Benzenesulfonate;

(RS)-(8-Methyl-8-Azabicyclo[3.2.1]Oct-3-Yl) 51-55-8 Atropine 3-Hydroxy-2-Phenylpropanoate;

1-[4-(1,1-Dimethylethyl)Phenyl]-3-(4-Methoxyphenyl)- 70356-09-1 Avobenzone 1,3-Propanedione;

Nonanedioic Acid; Azelate; Nonanedioate 123-99-9

10

Azelastine Impurity-B 110406-94-5 Azelastine

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3, 4,10-Trihydroxy-3,5,6,8,10,12,14-Heptamethyl-15-Oxo- 11- {[3,4,6-Trideoxy-3-(Dimethylamino)-Β-D-Xylo- 83905-01-5 Azithromycin Hexopyranosyl]Oxy}-1-Oxa-6-Azacyclopentadec-13-Yl 2,6-Dideoxy-3-C-Methyl-3-O-Methyl-Α-L-Ribo -Hexopyranoside;

[2S-[2α,3β(Z)]]-2-[[(Z)-[1-(2-Amino-4-Thiazolyl)-2- [[(2S,3S)-2-Methyl-4-Oxo-1-Sulfo-3-Azetidinyl]Amino]- 78110-38-0 Aztreonam 2-Oxoethylidene]Amino]Oxy]-2-Methylpropanoic Acid;

(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-Bis (Acetyloxy)-12-(Benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12 ,12a,12b-Dodecahydro-4,9,11-Trihydroxy-4a,8,13,13 27548-93-2 Baccatin III -Tetramethyl-7,11-Methano-5H-Cyclodeca[3,4]Benz [1,2-B]Oxet-5-One;

5-[(1E)-2-[4-[[(2-Carboxyethyl)Amino]Carbonyl]Phenyl] 80573-04-2 Diazenyl]-2-Hydroxybenzoic Acid;

Balsalazide Balsalazide Disodium - 5-[(1E)-[4-[[(2-Carboxyethyl) Amino]Carbonyl]Phenyl]Azo]-2-HydroxyBenzoic Acid, 150399-21-6 -, Disodium Salt, Dihydrate (9CI);

1,2-Bis(2-Aminophenoxy)Ethane-N,N,N’,N’-Tetraacetic Acid; N,N'-[1,2-Ethanediylbis(Oxy-2,1-Phenylene)] 85233-19-8 BAPTA Bis[N-(Carboxymethyl)Glycine; BAPTA;

9α-Chloro-16β-Methylprednisolone 17,21-Dipropionate; Beclomethasone 5534-09-8 Aerobec; Aldecin; Beclometasone Dipropionate Dipropionate

(3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-Phenylpropyl]Amino]- 2,3,4,5-Tetrahydro-2-Oxo-1H-1-Benzazepine-1-Acetic 86541-74-4 Benazepril Hydrochloride Acid Hydrochloride; Lotensin;

11

5-[Bis(2-Chloroethyl)-Amino]-1-Methyl-1H-Benzimidazole-2 Bendamustine -Butanoic Acid Hydrochloride; Cytostasan; Ribomustin; 3543-75-7 Hydrochloride Treanda

1-[1-[4-(4-Fluorophenyl)-4-Oxobutyl]-4-Piperidinyl]-1,3- Dihydro-2H-Benzimidazol-2-One; 1-[1-[3-(P-Fluorobenzoyl) 2062-84-2 Benperidol Propyl]-4-Piperidyl]-2-Benzimidazolinone;

6-Hydroxy bentazone 60374-42-7 Bentazone

Alkyldimethylbenzylammonium Chloride; Arquad CB 30; BTC; BTC 2565; BTC 471; Benzalkon A; Benzalkonium Chloride; Biowash; Cedium; Culversan LC 80; 8001-54-5 Benzalkonium Chloride Dimanin A; Erional EL; Genamin KDS; Kemamine BAC; Konrapo; Leda Benzalkonium Chloride; Magna M 407;

Rac Xanthoanthrafil; N-[(3,4-Dimethoxyphenyl)Methyl]-2- 1020251-53-9 Benzamidenafil [(2-Hydroxy-1-Methylethyl)Amino]-5-Nitro-Benzamide;

(3,5-Dibromo-4-Hydroxyphenyl)(2-Ethyl-3- Benzofuranyl)Methanone; 3,5-Dibromo-4-Hydroxyphenyl 2-Ethyl- 3562-84-3 Benzbromarone 3-Benzofuranyl

Benzene Sulphonic Acid; Benzenesulphonic Acid; Phenylsulfonic 98-11-3 Benzenesulfonic Acid Acid; Phenylsuphonic Acid;

Α-Phenyl-Benzenemethanamine; 1-Amino-1- 91-00-9 Benzhydrylamine (Phenylmethyl);

1,3-Benzodiazole; BZI; 1H-Benzoimidazole; 51-17-2 Benzimidazole

4-Aminobenzoic Acid Ethyl Ester; P-Aminobenzoic Acid 94-09-7 Benzocaine Ethyl Ester; Ethyl 4-Aminobenzoate; Anaesthan-Syngala

12

Benzotropine Mesylate; Cogentin; Cogentinol; Benztropine 132-17-2 Benztropine Mesylate Methanesulfonate;

N,N-Dimethyl-3-[[1-(Phenylmethyl)-1H-Indazol-3-Yl]Oxy] 132-69-4 Benzydamine Hydrochloride -1-Propanamine Hydrochloride;

Benzyl Alcohol -Α-Toluenol; (Hydroxymethyl)Benzene; 100-51-6 Benzenecarbinol;

Benzyl Benzoate - Benzyl Ester Benzoic Acid; Ascabin; Ascabiol; Benylate; Benzyl Benzenecarboxylate; Scobenol; 120-51-4 Vanzoate; Venzonate;

Benzyl Chloride - 6-(Chloromethyl)Benzene; 100-44-7 Α-Chlorotoluene;

Benzyl Nicotinate - Nicotinic Acid Benzyl Ester; 94-44-0

Benzyl Benzathine Benzylpenicillin; 1538-09-6

Benzyl Penicillinate Potassium Salt; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(2-Phenylacetyl) Amino]-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 113-98-4 Acid Potassium Salt; Potassium Benzylpenicillin; Potassium Benzylpenicillinate;

Procaine Benzylpenicillin; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(Phenylacetyl)Amino] -4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 6130-64-9 Acid Compd. With 2-(Diethylamino)Ethyl 4-Aminobenzoate Hydrate;

4-[(S)-(4-Chlorophenyl)-2-Pyridinylmethoxy]-1- Piperidinebutanoic Acid Benzenesulfonate; Bepreve; 190786-44-8 Bepotastine Besylate TAU 284; Talion;

13

Dl-4-[(1R,2R,3aS,8bS)-2,3,3a,8b-Tetrahydro-2-Hydroxy- [(3S,4RS)-3-Hydroxy-4-Methyl-Oct-6-Yne-(E)-1-Enyl]- 88475-69-8 Beraprost Sodium 5-Cyclopenta[B]Benzofuranyl]Butanoic Acid Sodium

4-[[(2E)-3,7-Dimethyl-2,6-Octadien-1-Yl]Oxy]-7H-Furo 7380-40-7 Bergamottin [3,2-G][1]Benzopyran-7-One

N-Methyl-2-Pyridineethanamine Dihydrochloride; 5579-84-0 Betahistine Dihydrochloride Sinmenier; Vasomotal;

N-(Methyl-D3)-2-Pyridineethanamine Hydrochloride; 15430-48-5 Betahistine Hydrochloride

1-Carboxy-N,N,N-Trimethyl-Methanaminium Inner Salt; (Carboxymethyl)Trimethylammonium Hydroxide Inner Salt; (Trimethylammonio)Acetate; Abromine; Aminocoat; 107-43-7 Betaine Aquadew AN 100; Betafin; Betafin BCR; Betafin BP; Betafin BP 20; Cystadane;

Betamethasone - (11β,16β)-9-Fluoro-11,17,21-Trihydroxy-16- 378-44-9 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Acetate - Betamethasone 21-Acetate; (11β,16β)-21-(Acetyloxy)-9-Fluoro-11,17-Dihydroxy-16- 987-24-6 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Betamethasone Dipropionate - (11β,16β)-9-Fluoro-11- Hydroxy-16-Methyl-17,21-Bis(1-Oxopropoxy)-Pregna-1, 5593-20-4 4-Diene-3,20-Dione;

Betamethasone Sodium Phosphate - Betamethasone 21-Phosphate Disodium Salt; (11β,16β)-9-Fluoro-11, 151-73-5 17-Dihydroxy-16-Methyl-21-(Phosphonooxy)Pregna-1,4- Diene-3,20-Dione Sodium Salt;

14

1-[4-[2-(Cyclopropylmethoxy)Ethyl]Phenoxy]-3- 63659-19-8 Betaxolol Hydrochloride [(1-Methylethyl)Amino]-2-Propanol Hydrochloride;

2-[4-[2-[(4-Chlorobenzoyl)Amino]Ethyl]Phenoxyl]-2- 41859-67-0 Bezafibrate Methylpropanoic Acid; BM-15075;

Biapenem Impurity 120410-24-4 Biapenem

N-[4-Cyano-3-Trifluoromethyl)Phenyl]-3-[(4- 90357-06-5 Fluorophenyl)Sulfonyl]- 2-Hydroxy-2-Methylpropanamide

4-Amino-5-Bromo-N-[2-(Diethylamino)Ethyl]-2- 4093-35-0 Bromopride Methoxybenzamide

Γ-(4-Bromophenyl)-N,N-Dimethyl-2- Pyridinepropanamine Maleate; 2-[P-Βromo-Α-[2-(Dimethylamino)Ethyl]Benzyl]Pyridine 980-71-2 Bromphen-iramine Maleate Maleate; (+/-)-Brompheniramine Maleate; Bromphen Maleate;

(RS)-1-[(4-Chlorophenyl)- Phenyl-Methyl]-4- 82-92-1 Buclizine [(4-Tert-Butylphenyl) Methyl] Piperazine;

(11β,16α)-16,17-[Butylidenebis(Oxy)]-11,21-Dihydroxypregna-1,4- 51333-22-3 Budesonide Diene-3,20-Dione;

4-Butoxy-N-Hydroxybenzeneacetamide; Parfenal; Trolab; P- Butoxyphenylacethydroxamic Acid; 2438-72-4 Bufexamac P-Butoxyphenylacetohydroxamic Acid;

4-(1-Pyrrolidinyl)-1-(2,4,6-Trimethoxyphenyl)-1-Butanone 35543-24-9 Buflomedil Hydrochloride Hydrochloride;

15

5-[3-[(1,1-Dimethylethyl)Amino]-2-Hydroxypropoxy]-3, 31969-05-8 Bunolol Hydrochloride 4-Dihydro-1(2H)-Naphthalenone Hydrochloride;

4-Hydroxy-Α-[1-[(1-Methyl-3-Phenylpropyl)Amino]Ethyl] Benzenemethanol; P-Hydroxy-N-(1-Methyl-3- Phenylpropyl)Norephedrine; P-Hydroxy-N-(1-Methyl-3- 447-41-6 Buphenine Hydrochloride Phenylpropyl) Norphedrine;

Bupivacaine Hydrochloride 1-Butyl-N-(2,6-Dimethylphenyl)-2-Piperidinecarboxamide; 73360-54-0 Monohydrate

Bupropion USP Related Compound B 1049718-43-5

Bupropion USP Related Compound A 1049718-72-0

Bupropion USP Related Compound E 10557-17-2

Bupropion 3,4-Dichloro Impurity 1193779-34-8 Bupropion

Bupropion 3,5-Dichloro Impurity 1193779-48-4

Bupropion amino -Bupropion Amino Impurity 119802-69-6

Bupropion Hydrochloride -1-(3-Chlorophenyl)-2- 31677-93-7 [(1,1-Dimethylethyl)Amino]-1-Propanone Hydrochloride

8-[4-[4-(2-Pyrimidinyl)-1-Piperazinyl]Butyl]-8-Azaspiro 33386-08-2 Buspirone Hydrochloride [4.5]Decane-7,9-Dione; Ansial;

Butetamate Citrate; 13900-12-4 Butetamate Citrate

16

4-Hydroxybenzoic Acid Butyl Ester; Butyl 94-26-8 4-(Butoxycarbonyl)Phenol; Parahydroxybenzoate

(1,1-Dimethylethyl)-4-Methoxyphenol; 25013-16-5 Butylhydroxyanisole 2(3)-Tert-Butyl-4-Hydroxyanisole;

2,6-Bis(1,1-Dimethylethyl)-4-Methylphenol; 128-37-0 Butylhydroxytoluene

(ΑR,ΒS)-Β-[[ (1,1-Dimethylethoxy) Carbonyl]Amino] -Α-Hydroxybenzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS) -12b-(Acetyloxy) -12-(Benzoyloxy) 183133-96-2 Cabazitaxel -2a,3,4,4a,5,6,9,10,11,12,12a,12b- Dodecahydro-11-Hydroxy-4, 6-Dimethoxy-4a,8,13,13- Tetramethyl-5-Oxo-7,11-Met

CI-103N-[4-(3-Chloro-4-Fluorophenylamino)-7- (3-Morpholin-4-Ylpropoxy)Quinazolin-6-Yl]Acrylamide 289499-45-2 Canertinib Dihydrochloride Dihydrochloride

Capecitabine impurity D 161599-46-8 Capecitabine

10,11-dihydro-10,11-dioxo 537693-29-1 Carbamazepine

Carglumic acid Impurity 1188-38-1 Carglumic Acid

Cetirizine N-Oxide 1076199-41-1 Cetirizine Cetirizine EP Impurity B 83881-51-0

4-Chlorobenzotrifluoride 98-56-6 Chlorobenzotrifluoride

17

Ciprofloxacin EP Impurity B 93107-11-0 Ciprofloxacin

Citalopram Impurity B 411221-53-9 Citalopram Citalopram Impurity A 64372-56-1

Clonazepam Impurity - A,B 55198-89-5 Clonazepam Impurity A 55198-89-5

Clopidogrel Impurity 113665-84-2 Clopidogrel Clopidogrel Related compound C 120202-71-3

Clotrimazole EP Impurity D 288-32-4 Clotrimazole Clotrimazole EP Impurity C 42074-68-0

Darifenacin Bromo Impurity 127264-14-6 Darifenacin Darifenacin Carboxylic Acid Impurity 69999-16-2

Debenzyl Donepezil 120013-39-0 Debenzyl

Dehydro Aripiprazole Impurity 1008531-60-9 Dehydro Aripiprazole

Desloratadine impurity A 38092-95-4 Desloratadine Dehydro Desloratidine 117811-20-8

18

Desloratadine Impurity 100643-71-8

Desloratadine N-acyl 117796-52-8

Desloratadine N-Acetyl Impurity 117796-52-8

N-Formyl Desloratadine 117810-61-4

Desloratadine N-hydroxy 1193725-73-3

Desloratadine N-Hydroxy Impurity 1193725-73-3

Desloratadine 3-hydroxy 119410-08-1

Dexpramipexole Dexpramipexole Dihydrochloride Impurity 104632-27-1 Dihydrochloride

Dipyramidole Impurity D 1176886-12-6 Dipyramidole

Domperidone N-Oxide 118435-03-3

Donepezil Impurity VI 120012-04-6

Donepezil Deoxy Impurity 1034439-57-0

Donepezil N-oxide 120013-84-5 Donepezil

Donepezil Dihydro Impurity 120012-04-6

Donepezil Dehydro Deoxy Impurity 120013-45-8

19

DORZOLAMIDE Related Compound B 120279-37-0 Dorzolamide

Duloxetine Impurity EP F 116817-28-8 Duloxetine Duloxetine Impurity F 116817-28-8

Etofenamate Impurity C 101-23-5 Etofenamate

Famciclovir Impurity 104227-87-4 Famciclovir

4-(2,3-Dichlorophenyl)-1,4-Dihydro-2,6-Dimethyl-3, 5-Pyridinedicarboxylic Acid Ethyl Methyl Ester; 72509-76-3 Felodipine Feloday; Flodil;

Glibenclamide Impurity 10238-21-8 Glibenclamide

Ibuprofen Impurity B 3585-49-7 Ibuprofen

4-[(4-Methylpiperazin-1-Yl)Methyl]-N-(4-Methyl-3- {[4-(Pyridin-3-Yl)Pyrimidin-2-Yl]Amino}Phenyl) 152459-95-5 Imatinib Benzamide;

Dabigatran Isopropyll Ester Impurity 211915-06-9 Isopropyl Ester

Isorizatriptan 208941-96-2 Isorizatriptan

Lacidipine Impurity 103890-78-4 Lacidipine

Lansoprazole Impurity 103577-45-3 Lansoprazole

Lercanidipine Impurity B 1119226-97-9 Lercanidipine

20

Letrozole Impurity 113402-31-6 Letrozole

Levetiracetam Impurity 102767-28-2 Levetiracetam

Lidocaine Impurity K 50295-20-0 Lidocaine Lidocaine Impurity - A,C,H,D,F,G,I,J,K 50295-20-0

Lisinopril cyclohexyl analogue 1132650-67-9 Lisinopril Lisinopril Dihydrate EP Impurity 1012-05-1

Lopinavir EP Impurity T 192725-17-0 Lopinavir

3-Hydroxy loratadine 183483-15-0

4-Hydroxymethyl loratadine 609806-40-8 Loratadine Loratadine USP RC A 100643-71-8

Loratadine EP Impurity F 125743-80-8

Losartan Impurity J 1006062-27-6

Losartan Carboxylic Acid 124750-92-1 Losartan

Losartan Impurity H 124751-00-4

Maleic acid 110-16-7 Maleic acid

21

Masalazine Impurity L 118-91-2 Masalazine

Metoprolol Impurity O (EP) 154784-36-8 Metoprolol Metoprolol Impurity A 109632-08-8

Metronidazol Impurity G 1010-93-1 Metronidazol

Modafinil Related Compound - A,B,C,D,E 63547-24-0

Modafinil Related Compound A 63547-24-0 Modafinil

Modafinil Related Compound B 118779-53-6

Moxifloxacin Impurity B 1029364-73-5 Moxifloxacin MoxifloxacinImpurity 1029364-77-9

Nateglinide Impurity 105816-04-4 Nateglinide

Nevirapine Impurity 129618-40-2 Nevirapine

Nortriptyline Impurity C 1156-99-6 Nortriptyline

Ofloxacin Impurity B 123155-82-8 Ofloxacin

Olanzapine EP Impurity B 221176-49-4 Olanzapine Olanzapine EP Impurity C 719300-59-1

22

Olanzapine Lactam 1017241-34-7

Olanzapine Thiolactam Impurity 1017241-36-9

Omeprazole Hydrolysis Impurity 1227380-90-6 Omeprazole

Ondansetron EP Impurity H 9614-14-9

Ondansetron Hydrochloride Dihydrate 103639-04-9 Ondansetron

Ondansetron EP Impurity A 119812-29-2

Oseltamivir EP Impurity H 814-29-9 Oseltamivir

Oxeladine Impurity A (EP) - Oxeladine

Oximinostilbene - Oximinostilbene

Oxybutynin Impurity A 1199574-71-4 Oxybutynin

Pantoprazole Impurity B 102625-64-9

Pantoprazole Impurity A 127780-16-9 Pantoprazole

Pantoprazole Sulfone 127780-16-9

Paroxetine Impurity C 105813-13-6 Paroxetine

Piroxicam Impurity L 118854-48-1 Piroxicam

23

Pramipexole EP Impurity E 105816-05-5

Pramipexole EP Impurity A 106092-09-5 Pramipexole

Pramipexole EP Impurity B 1246815-83-7

rac 4,5-Dehydro Pregabalin 216576-74-8 Pregabalin

Propafenone Impurity E 165279-79-8 Propafenone

Propranolol Impurity C (EP) - Propranolol

Prulifloxacin Impurity 123447-62-1 Prulifloxacin

Quetipine Hemifumarate Impurity 111974-72-2 Quetipine Hemifumarate

Rivastigmine tartarate working standard 123441-03-2 Rivastigmine

3 Oxo Ropinirole Impurity 102842-51-3

Ropinirole N-Oxide 1070377-34-2 Ropinirole

Ropinirole Hcl -N-Despropyl Ropinirole HCl 106308-44-5

Rosuvastatin diastereomer / Rosuvastatin 1093959-75-1 Rosuvastatin Calcium

Rufinamide Impurity 106092-09-5 Rufinamide

Simvastatin anhydro Impurity C 210980-68-0 Simvastatin

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Simvastatin Impurity A -

Zoledronic Acid Impurity 118072-93-8 Soledronic

Telmisartan Impurity B 1026438-56-1 Telmisartan

Tranexamic acid Impurity A - Tranexamic acid

Tropicamide Impurity A 33403-97-3 Tropicamide

[3-[[2-Methoxy-4-[[[ (2-Methylphenyl)Sulfonyl]Amino] Carbonyl]Phenyl]Methyl]-1-Methyl -1H-Indol-5-Yl] 107753-78-6 Zafirlukast Carbamic Acid Cyclopentyl Ester

N-[3-(3-Cyanopyrazolo[1,5-A]Pyrimidin-7-Yl)Phenyl] 151319-34-5 -N-Ethylacetamide; CL-284846; Sonata

API IMPURITIES

Top of Form

Bottom of Form

API IMPURITIES PRODUCTS LIST

Impurity Name CAS No. Product Name

1,6- Dibromohexane 629-03-8 1, 6- Dibromohexane

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(1S,4R)-4-[2-Amino-6-(Cyclopropylamino)-9H-Purin-9-Yl]-2- 136470-78-5 Abacavir Cyclopentene-1-Methanol

Avermectin B1; MK-936; Agri-Mek; Avid; Zephyr; 71751-41-2 Abamectin

(1R,4aR,4bR,10aR)-1,2,3,4,4a,4b,5,6,10,10a-Decahydro-1,4a- Dimethyl-7-(1-Methylethyl)-1-Phenanthrenecarboxylic 514-10-3 Abietic Acid Acid;

(3β)-17-(3-Pyridinyl)Androsta-5,16-Dien-3-Ol 154229-18-2 Abiraterone Acetate Acetate (Ester); CB 7630;

2-(4-Methoxyphenyl)-5, 7-Dihydroxy-4H-1-Benzopyran-4-One; 480-44-4 Acacetin 4’-O-Methylapigenin;

5-Aminoimidazole-4-Carboxamide-1-Β-D-Ribofuranoside; 2627-69-2 Acadesine

O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6 -Trihydroxy-3-(Hydroxymethyl)-2-Cyclohexen-1-Yl] 56180-94-0 Acarbose Amino]-Α-D-Glucopyranosyl-(1→4)-O-Α-D -Glucopyranosyl-(1→4)-D-Glucose;

Ambroxol Theophylline-7-Acetic Acid; 179118-73-1 Acebrophylline

N-[3-Acetyl-4-[2-Hydroxy-3-[(1-Methylethyl)Amino] 34381-68-5 Acebutolol Hydrochloride Propoxy]Phenyl]Butanamide Hydrochloride;

Aceclofenac Impurity F (EP) 100499-89-6

Aceclofenac Aceclofenac (WS); 2-[(2,6-Dichlorophenyl)-Amino] 89796-99-6 Benzeneacetic Acid Carboxymethyl Ester;

26

4-(Acetylamino)Benzoic Acid; 4-Acetamidobenzoic Acid 556-08-1 Acedoben

Theophylline-7-Acetic Acid; 1,2,3,6-Tetrahydro-1,3-Dimethyl 652-37-9 Acephylline -2,6-Dioxo-7H-Purine-7-Acetic Acid;

Ethanimidamide Hydrochloride; 124-42-5 Acetamidine Hydrochloride

N-(4-Hydroxyphenyl)Acetamide; 103-90-2 Acetaminophen

N-[5-Aminosulfonyl)-1,3,4-Thiadiazol-2-Yl]Acetamide; 59-66-5 Acetazolamide

N-Hydroxyacetamide; Ethanehydroxamic Acid; AHA; Acetic Acid Oxime; Acetohydroximic Acid; 546-88-3 Acetohydroxamic Acid Acetylhydroxamic Acid;

N-Acetyl-L-Cysteine; ACC; Acetadote; 616-91-1 Acetylcysteine

2-Acetoxybenzoic Acid; 2-(Acetyloxy)Benzoic Acid; 50-78-2 Acetylsalicylic acid Acylpyrin; Angettes; Aspro; Aspirin; ASA;

10-Azaanthracene; 2,3-Benzoquinoline; 260-94-6 Acridine

2-Amino-1, 59277-89-3 Acyclovir 9-Dihydro-9-[(2-Hydroxyethoxy)Methyl]-6H-Purin-6-One;

Tricyclo[3.3.1.1(3,7)]Decan-1-Amine; 1-Adamantanamine; Adamantamine; Adamantanamine; 768-94-5 Adamantamine Adamantylamine;

6-(4-Methoxy-3-Tricyclo[3.3.1.13,7]Dec-1-Ylphenyl)- 106685-40-9 Adapalene 2-Naphthalenecarboxylic Acid;

27

P’-[[2-(6-Amino-9H-Purin-9-Yl)Ethoxy]Methyl] Adefovir Phosphate - Isohypophosphoric Acid Triethylamine Salt; Triethylamine

9-Β-D-Ribofuranosyl-9H-Purin-6-Amine; 58-61-7 Adenosine

(6S,7S)-7-[(Hydroxyamino)Carbonyl]-6- [(4-Phenyl-1-Piperazinyl)Carbonyl]-5-Azaspiro[2.5] 791828-58-5 Aderbasib Octane-5-Carboxylic Acid Methyl Ester; INCB 007839;

Α-Phenylbenzeneacetic Acid 2-(Diethylamino)Ethyl Ester 50-42-0 Adiphenine Hydrochloride Hydrochloride

(−)-Epinephrine (+)-Bitartrate Salt; L-3,4-Dihydroxy-Α-(Methylaminomethyl)Benzyl 51-42-3 Adrenaline Tartrate Alcohol D-Hydrogen Bitartrate Salt;

Escin; Aescin; Chestnuts Extract; 11072-93-8 Aescin

Aflatoxin B1; (6aR,9aS)-2,3,6a,9a-Tetrahydro- 4-Methoxy-1H,11H-Cyclopenta[C]Furo[3’,2’:4,5] 1162-65-8 Aflatoxin Furo[2,3-H][1]Benzopyran-1,11-Dione;

6-Amino-2-(Fluoromethyl)-3-(2-Methylphenyl)- 56287-74-2 Afloqualone Quinazolin-4-One

N-[2-(7-Methoxy-1-Naphthalenyl)Ethyl]Acetamide; N-[2-(7-Methoxy-1-Naphthyl) Ethyl]Acetamide; 138112-76-2 Agomelatine S 20098; Valdoxan;

DL-Alanine; (R,S)-Alanine; 302-72-7 Alanine

N-[6-(Propylthio)-1H-Benzimidazol-2-Yl]Carbamic Acid Methyl Ester; [5-(Propylthio)-1H-Benzimidazol-2-Yl] 54965-21-8 Albendazole Carbamic Acid Methyl Ester; Albenza; Andazol;

28

Salbutamol Sulphate; Α1-[[(1,1-Dimethylethyl)Amino]Methyl] 51022-70-9 Albuterol Sulfate -4-Hydroxy-1,3-Benzenedimethanol Sulfate; Aerolin;

6,11-Dihydro-11-(1-Methyl-4-Piperidinylidene)- 5H-Imidazo[2,1-B][3]Benzazepine-3-Carboxaldehyde; 147084-10-4 Alcaftadine R 89674

(11β)-11,21-Dihydroxy-3,20-Dioxopregn-4-En-18-Al; 52-39-1 Aldosterone

N-[3-[(4-Amino-6,7-Dimethoxy-2-Quinazolynyl) 81403-68-1 Alfuzosin Hydrochloride Methylamino]Propyl]Tetrahydro-2-Furancarboxamide;

5,5-Diallybarbituric Acid; 5,5-Di-2-Propenyl-2,4,6 52-43-7 Allobarbital (1H,3H,5H)Pyrimidinetrione; Allobarbitone

1,5-Dihydro-4H-Pyrazolo[3,4-D]Pyrimidin-4-One; 1H-Pyrazolo(3,4-D)Pyrimidin-4-Ol; 315-30-0 Allopurinol 4-Hydroxypyrazolo(3,4-D)Pyrimidine; 4-Hydroxypyrazolo[3,4-D]Pyrimidine; HPP

8-Chloro-1-Methyl-6-Phenyl-4H-[1,2,4] Triazolo[4,3-A][1,4]Benzodiazepine; 8-Chloro-1-Methyl-6-Phenyl-4H-S-Triazolo[4,3-A][1,4] 28981-97-7 Alprazolam Benzodiazepine; Tensivan; Trankimazin; Tranquinal; Tricalma; U 31889; Valeans; Xanagis; Xanax; Xanax TS; Xanolam; Xanor; Zolam; Zo

N-Ethyl-N-(3-Phenylpropyl)Benzenepropanamine 5560-59-8 Alverine Citrate 2-Hydroxy-1,2,3- Propanetricarboxylate;

Tricyclo[3.3.1.13,7]Decan-1-Amine Hydrochloride 665-66-7 Amantadine Hydrochloride

4-[[(2-Amino-3,5-Dibromophenyl)Methyl]Amino] 23828-92-4 Ambroxol Hydrochloride Cycophexanol Hydrochloride;

29

N-Amidino-3,5-Diamino-6-Chloropyrazinecarboxamide Amiloride Hydrochloride 17440-83-4 Hydrochloride Dihydrate; Dihydrate

(2-Butyl-3-Benzofuranyl)[4-[2-(Diethylamino)Ethoxy] 19774-82-4 Amiodarone Hydrochloride -3,5-Diiodophenyl]Methanone Hydrochloride;

4-Amino-N-[(1-Ethyl-2-Pyrrolidinyl)Methyl]-5- (Ethylsulfonyl)-2-Methoxybenzamide; Aminosultopride; 71675-85-9 Amisulpride DAN-2163; Socian; Solian; Sulamid;

N’-(2,4-Dimethylphenyl)-N-[[(2,4-Dimethylphenyl)Imino] 33089-61-1 Amitraz Methyl]-N-Methyl-Methanimidamide;

3-(10,11-Dihydro-5H-Dibenzo[A,D]Cyclohepten-5-Ylidene) 549-18-8 Amitriptyline Hydrochloride -N,N-Dimethyl-1-Propanamine Hydrochloride

Amlodipine EP Impurity I, Amlodipine Besilate - 2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-1,4 111470-99-6 -Dihydro-6-Methyl-3,5-Pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester Benzenesulfonate;

Amlodipine Impurity D (EP) 113994-41-5

2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-3- Amlodipine Ethoxycarbonyl-5-Methoxycarbonyl)-6-Methyl-1,4 88150-42-9 -Dihydropyridine;

Amlodipine EP Impurity G 43067-01-2

Amlodipine Maleate - Diethyl 2-((2-Aminoethoxy)Methyl)-4-(2-Chlorophenyl) 1357024-06-6 -6-Methyl-1,4-Dihydropyridine-3,5-Dicarboxylate Maleate;

30

Amlodipine Mesilate; 246852-12-0

4-[(7-Chloro-4-Quinolinyl)Amino]-2-[(Diethylamino)Methyl] Amodiaquine 6398-98-7 Phenol Dihydrochloride; Dihydrochloride Dihydrate

5-Amino-2-[2-(Dimethylamino)Ethyl]-1H-Benz[De] 69408-81-7 Amonafide Isoquinoline-1,3(2H)-Dione;

Amoxicillin; (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-Hydroxyphenyl)Acetyl] 61336-70-7 Amoxicillin Trihydrate Amino]-3,3-Dimethyl-7-Oxo-4-Thia-1-Azabicyclo[3.2.0] Heptane-2-Carboxylic Acid;

Ampicillin Sodium - D-(-)-6-(2-Amino-2-Phenylacetamido)-3,3-Dimethyl -7-Oxo-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 69-52-3 Acid Monosodium Salt; Binotal Sodium; Britapen Injection; Cilleral; D-Α-Aminobenzylpenicillin Sodium Salt; Ampicillin Ampicillin Sodium Salt; Ampicillin-Na; Ampicin

Ampicillin Trihydrate - D-(−)-Α-Aminobenzylpenicillin; 7177-48-2

Anastrozole Impurity E 1027160-12-8

Anastrozole Impurity 120511-73-1

Anastrozole Impurity D 120511-84-4 Anastrozole

Anastrozole Impurity B 1215780-15-6

Anastrozole Impurity C 1216898-82-6

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(5α,17β)-17-Hydroxyandrostan-3-One; 521-18-6 Androstanolone Dihydrotestosterone; 5α-Dihydrotestosterone; Stanolone;

3α-Hydroxy-5α-Androstan-17-One, 53-41-8 Androsterone 5α-Androstan-3α-Ol-17-One;

1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(Pentyloxy) [1,1':4',1"-Terphenyl]-4-Yl]Carbonyl]-L-Ornithine] 166663-25-8 Anidulafungin Echinocandin B; Ecalta; Eraxis; LY 303366;

Antazoline Hydrochloride - 4,5-Dihydro-N-Phenyl-N- (Phenylmethyl)-1H-Imidazole-2-Methanamine 2508-72-7 Hydrochloride 4,5-Dihydro-N-Phenyl-N-(Phenylmethyl) -1H-Imidazole-2-Methanamine Monohydrochloride Antazoline

Antazoline Phosphate - Antistine Phosphate; 154-68-7 2-[(N-Benzylanilino)Methyl]-2-Imidazoline Phosphate;

5,7-Dihydroxy-2-(4-Hydroxyphenyl)-4H-1- Benzopyran-4-One; 4’,5,7-Trihydroxyflavone; 520-36-5 Apigenin Pelargidenon 1449

(6aR)-5,6,6a,7-Tetrahydro-6-Methyl-4H-Dibenzo[De,G] Apomorphine 41372-20-7 Quinoline-10,11-Diol Hydrochloride Hemihydrate Hydrochloride Hemihydrate

N1-(2,3-Dihydro-1H-Inden-2-Yl)-N3,N3-Diethyl-N1- 33237-74-0 Aprindine Hydrochloride Phenyl-1,3-Propanediamine Hydrochloride;

(5Z,8Z,11Z,14Z)-5,8,11,14-Eicosatetraenoic Acid; 506-32-1 Arachidonic Acid

1,2,5,6-Tetrahydro-1-Methyl-3-Pyridinecarboxylic 300-08-3 Arecoline Hydrobromide Acid Methyl Ester Hydrobromide;

32

(2R,4R)1-[(2S)2-Amino-5-[[Imino(Nitroamino)Methyl] Amino]-1-Oxopentyl]-4-Methyl-2-Piperidinecarboxylic 74874-08-1 Argatroban Acid Ethyl Ester Hydrochloride; Argatroban Intermediate;

Arginine - L-Arginine; Arginine; Argivene; Detoxargin; 74-79-3 L-(+)-Arginine; Arginine Arginine Hydrochloride - L-Arginine Hydrochloride; 1119-34-2 L-Arginine Monohydrochloride;

Argirelin Acetate(Acetyl Hexapeptide-3); 616204-22-9 Argireline Acetate

Aripiprazole Impurity D 882880-12-8

Aripiprazole Impurity E 120004-79-7 Aripiprazole

Aripiprazole - 7-[4-[4-(2,3-Dichlorophenyl)-1-Piperazinyl] 129722-12-9 Butoxy]-3,4-Dihydro-2(1H)-Quinolinone;

8-Methoxybenzo[F]-1,3-Benzodioxolo[6,5,4-Cd]Indol- 13395-02-3 Aristolactam 5(6H)-One; Aristolactam

Butanedioic Acid Mono(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-3,6 88495-63-0 Artesunate ,9-Trimethyl-3,12-Epoxy-12H-Pyrano[4,3-J]-1,2- Benzodioxepin-10-Yl] Ester; Artesunic Acid

Carticaine Hydrochloride; 4-Methyl-3-[2-(Propylamino) Propionamido]-2-Thiophenecarboxylic Acid Methyl 23964-57-0 Articaine Hydrochloride Ester Hydrochloride;

Changchuanmycin; Immunomycin; FK 520; FR 520; 104987-12-4 Ascomycin FR 900520; L 683590;

33

L-Ascorbic Acid; (+)-Ascorbic Acid; 100M; 50-81-7 Ascorbic Acid L-Threo-Ascorbic Acid;

Asenapine N-oxide Impurity 128949-51-9

Asenapine (3aR,12bR)-Rel-5-Chloro-2,3,3a,12b-Tetrahydro-2- 65576-45-6 Methyl-1H-Dibenz[2,3:6,7]Oxepino[4,5-C]Pyrrole;

L-Α-Aspartyl-L-Phenylalanine 2-Methyl Ester; Canderel; 22839-47-0 Aspartame

(S)-(+)-Aminosuccinic Acid; (S)-Aminobutanedioic Acid; 56-84-8 Aspartic acid L-Aspartic Acid;

Aspirin Impurity - A,D,F,C 99-96-7 Aspirin Aspirin Impurity A (EP) 99-96-7

1-[(4-Fluorophenyl)Methyl]-N-[1-[2-(4-Methoxyphenyl) 68844-77-9 Astemizole Ethyl]-4-Piperidinyl]-1H-Benzimidazol-2-Amine;

Atenolol Impurity C 29122-69-8

Atenolol Impurity - H,F 87619-83-8 Atenolol

4-[2-Hydroxy-3-[(1-Methylethyl)Amino]Propoxyl] 29122-68-7 Benzeneacetamide;

Atorvastatin methyl ester 345891-62-5 Atorvastatin Atorvastatin ethyl ester 1146977-93-6

34

Atorvastatin Impurity H (EP) 125995-03-1

Atorvastatin Lactone 125995-03-1

Atorvastatin Acid - (3R,5R)-2-(4-Fluorophenyl)-3,5-Dihydroxy-5- 134523-00-5 (1-Methylethyl)-3-Phenyl-4-[(Phenylamino)Carbonyl] -1H-Pyrrole-1-Heptanoic Acid ;

Atovaquone methyl ether 129700-41-0 Atovaquone methyl ether

2,2’-[1,5-Pentanediylbis[Oxy(3-Oxo-3,1-Propanediyl)]] Bis[1-[(3,4-Dimethoxyphenyl)Methyl]-1,2,3,4-Tetrahydro- 64228-81-5 Atracurium Besylate 6,7-Dimethoxy-2-Methyl-Isoquinolinium Benzenesulfonate;

(RS)-(8-Methyl-8-Azabicyclo[3.2.1]Oct-3-Yl) 51-55-8 Atropine 3-Hydroxy-2-Phenylpropanoate;

1-[4-(1,1-Dimethylethyl)Phenyl]-3-(4-Methoxyphenyl)- 70356-09-1 Avobenzone 1,3-Propanedione;

Nonanedioic Acid; Azelate; Nonanedioate 123-99-9 Azelaic Acid

Azelastine Impurity-B 110406-94-5 Azelastine

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3, 4,10-Trihydroxy-3,5,6,8,10,12,14-Heptamethyl-15-Oxo- 11- {[3,4,6-Trideoxy-3-(Dimethylamino)-Β-D-Xylo- 83905-01-5 Azithromycin Hexopyranosyl]Oxy}-1-Oxa-6-Azacyclopentadec-13-Yl 2,6-Dideoxy-3-C-Methyl-3-O-Methyl-Α-L-Ribo -Hexopyranoside;

35

[2S-[2α,3β(Z)]]-2-[[(Z)-[1-(2-Amino-4-Thiazolyl)-2- [[(2S,3S)-2-Methyl-4-Oxo-1-Sulfo-3-Azetidinyl]Amino]- 78110-38-0 Aztreonam 2-Oxoethylidene]Amino]Oxy]-2-Methylpropanoic Acid;

(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-Bis (Acetyloxy)-12-(Benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12 ,12a,12b-Dodecahydro-4,9,11-Trihydroxy-4a,8,13,13 27548-93-2 Baccatin III -Tetramethyl-7,11-Methano-5H-Cyclodeca[3,4]Benz [1,2-B]Oxet-5-One;

5-[(1E)-2-[4-[[(2-Carboxyethyl)Amino]Carbonyl]Phenyl] 80573-04-2 Diazenyl]-2-Hydroxybenzoic Acid;

Balsalazide Balsalazide Disodium - 5-[(1E)-[4-[[(2-Carboxyethyl) Amino]Carbonyl]Phenyl]Azo]-2-HydroxyBenzoic Acid, 150399-21-6 -, Disodium Salt, Dihydrate (9CI);

1,2-Bis(2-Aminophenoxy)Ethane-N,N,N’,N’-Tetraacetic Acid; N,N'-[1,2-Ethanediylbis(Oxy-2,1-Phenylene)] 85233-19-8 BAPTA Bis[N-(Carboxymethyl)Glycine; BAPTA;

9α-Chloro-16β-Methylprednisolone 17,21-Dipropionate; Beclomethasone 5534-09-8 Aerobec; Aldecin; Beclometasone Dipropionate Dipropionate

(3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-Phenylpropyl]Amino]- 2,3,4,5-Tetrahydro-2-Oxo-1H-1-Benzazepine-1-Acetic 86541-74-4 Benazepril Hydrochloride Acid Hydrochloride; Lotensin;

5-[Bis(2-Chloroethyl)-Amino]-1-Methyl-1H-Benzimidazole-2 Bendamustine -Butanoic Acid Hydrochloride; Cytostasan; Ribomustin; 3543-75-7 Hydrochloride Treanda

1-[1-[4-(4-Fluorophenyl)-4-Oxobutyl]-4-Piperidinyl]-1,3- Dihydro-2H-Benzimidazol-2-One; 1-[1-[3-(P-Fluorobenzoyl) 2062-84-2 Benperidol Propyl]-4-Piperidyl]-2-Benzimidazolinone;

36

6-Hydroxy bentazone 60374-42-7 Bentazone

Alkyldimethylbenzylammonium Chloride; Arquad CB 30; BTC; BTC 2565; BTC 471; Benzalkon A; Benzalkonium Chloride; Biowash; Cedium; Culversan LC 80; 8001-54-5 Benzalkonium Chloride Dimanin A; Erional EL; Genamin KDS; Kemamine BAC; Konrapo; Leda Benzalkonium Chloride; Magna M 407;

Rac Xanthoanthrafil; N-[(3,4-Dimethoxyphenyl)Methyl]-2- 1020251-53-9 Benzamidenafil [(2-Hydroxy-1-Methylethyl)Amino]-5-Nitro-Benzamide;

(3,5-Dibromo-4-Hydroxyphenyl)(2-Ethyl-3- Benzofuranyl)Methanone; 3,5-Dibromo-4-Hydroxyphenyl 2-Ethyl- 3562-84-3 Benzbromarone 3-Benzofuranyl Ketone

Benzene Sulphonic Acid; Benzenesulphonic Acid; Phenylsulfonic 98-11-3 Benzenesulfonic Acid Acid; Phenylsuphonic Acid;

Α-Phenyl-Benzenemethanamine; 1-Amino-1- 91-00-9 Benzhydrylamine (Phenylmethyl)Benzene;

1,3-Benzodiazole; BZI; 1H-Benzoimidazole; 51-17-2 Benzimidazole

4-Aminobenzoic Acid Ethyl Ester; P-Aminobenzoic Acid 94-09-7 Benzocaine Ethyl Ester; Ethyl 4-Aminobenzoate; Anaesthan-Syngala

Benzotropine Mesylate; Cogentin; Cogentinol; Benztropine 132-17-2 Benztropine Mesylate Methanesulfonate;

N,N-Dimethyl-3-[[1-(Phenylmethyl)-1H-Indazol-3-Yl]Oxy] 132-69-4 Benzydamine Hydrochloride -1-Propanamine Hydrochloride;

Benzyl Alcohol -Α-Toluenol; (Hydroxymethyl)Benzene; 100-51-6 Benzyl Benzenecarbinol;

37

Benzyl Benzoate - Benzyl Ester Benzoic Acid; Ascabin; Ascabiol; Benylate; Benzyl Benzenecarboxylate; Scobenol; 120-51-4 Vanzoate; Venzonate;

Benzyl Chloride - 6-(Chloromethyl)Benzene; 100-44-7 Α-Chlorotoluene;

Benzyl Nicotinate - Nicotinic Acid Benzyl Ester; 94-44-0

Benzathine Benzylpenicillin; 1538-09-6

Benzyl Penicillinate Potassium Salt; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(2-Phenylacetyl) Amino]-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 113-98-4 Acid Potassium Salt; Potassium Benzylpenicillin; Potassium Benzylpenicillinate;

Procaine Benzylpenicillin; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(Phenylacetyl)Amino] -4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 6130-64-9 Acid Compd. With 2-(Diethylamino)Ethyl 4-Aminobenzoate Hydrate;

4-[(S)-(4-Chlorophenyl)-2-Pyridinylmethoxy]-1- Piperidinebutanoic Acid Benzenesulfonate; Bepreve; 190786-44-8 Bepotastine Besylate TAU 284; Talion;

Dl-4-[(1R,2R,3aS,8bS)-2,3,3a,8b-Tetrahydro-2-Hydroxy- [(3S,4RS)-3-Hydroxy-4-Methyl-Oct-6-Yne-(E)-1-Enyl]- 88475-69-8 Beraprost Sodium 5-Cyclopenta[B]Benzofuranyl]Butanoic Acid Sodium

4-[[(2E)-3,7-Dimethyl-2,6-Octadien-1-Yl]Oxy]-7H-Furo 7380-40-7 Bergamottin [3,2-G][1]Benzopyran-7-One

38

N-Methyl-2-Pyridineethanamine Dihydrochloride; 5579-84-0 Betahistine Dihydrochloride Sinmenier; Vasomotal;

N-(Methyl-D3)-2-Pyridineethanamine Hydrochloride; 15430-48-5 Betahistine Hydrochloride

1-Carboxy-N,N,N-Trimethyl-Methanaminium Inner Salt; (Carboxymethyl)Trimethylammonium Hydroxide Inner Salt; (Trimethylammonio)Acetate; Abromine; Aminocoat; 107-43-7 Betaine Aquadew AN 100; Betafin; Betafin BCR; Betafin BP; Betafin BP 20; Cystadane;

Betamethasone - (11β,16β)-9-Fluoro-11,17,21-Trihydroxy-16- 378-44-9 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Acetate - Betamethasone 21-Acetate; (11β,16β)-21-(Acetyloxy)-9-Fluoro-11,17-Dihydroxy-16- 987-24-6 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Betamethasone Dipropionate - (11β,16β)-9-Fluoro-11- Hydroxy-16-Methyl-17,21-Bis(1-Oxopropoxy)-Pregna-1, 5593-20-4 4-Diene-3,20-Dione;

Betamethasone Sodium Phosphate - Betamethasone 21-Phosphate Disodium Salt; (11β,16β)-9-Fluoro-11, 151-73-5 17-Dihydroxy-16-Methyl-21-(Phosphonooxy)Pregna-1,4- Diene-3,20-Dione Sodium Salt;

1-[4-[2-(Cyclopropylmethoxy)Ethyl]Phenoxy]-3- 63659-19-8 Betaxolol Hydrochloride [(1-Methylethyl)Amino]-2-Propanol Hydrochloride;

2-[4-[2-[(4-Chlorobenzoyl)Amino]Ethyl]Phenoxyl]-2- 41859-67-0 Bezafibrate Methylpropanoic Acid; BM-15075;

Biapenem Impurity 120410-24-4 Biapenem

39

N-[4-Cyano-3-Trifluoromethyl)Phenyl]-3-[(4- 90357-06-5 Bicalutamide Fluorophenyl)Sulfonyl]- 2-Hydroxy-2-Methylpropanamide

4-Amino-5-Bromo-N-[2-(Diethylamino)Ethyl]-2- 4093-35-0 Bromopride Methoxybenzamide

Γ-(4-Bromophenyl)-N,N-Dimethyl-2- Pyridinepropanamine Maleate; 2-[P-Βromo-Α-[2-(Dimethylamino)Ethyl]Benzyl]Pyridine 980-71-2 Bromphen-iramine Maleate Maleate; (+/-)-Brompheniramine Maleate; Bromphen Maleate;

(RS)-1-[(4-Chlorophenyl)- Phenyl-Methyl]-4- 82-92-1 Buclizine [(4-Tert-Butylphenyl) Methyl] Piperazine;

(11β,16α)-16,17-[Butylidenebis(Oxy)]-11,21-Dihydroxypregna-1,4- 51333-22-3 Budesonide Diene-3,20-Dione;

4-Butoxy-N-Hydroxybenzeneacetamide; Parfenal; Trolab; P- Butoxyphenylacethydroxamic Acid; 2438-72-4 Bufexamac P-Butoxyphenylacetohydroxamic Acid;

4-(1-Pyrrolidinyl)-1-(2,4,6-Trimethoxyphenyl)-1-Butanone 35543-24-9 Buflomedil Hydrochloride Hydrochloride;

5-[3-[(1,1-Dimethylethyl)Amino]-2-Hydroxypropoxy]-3, 31969-05-8 Bunolol Hydrochloride 4-Dihydro-1(2H)-Naphthalenone Hydrochloride;

4-Hydroxy-Α-[1-[(1-Methyl-3-Phenylpropyl)Amino]Ethyl] Benzenemethanol; P-Hydroxy-N-(1-Methyl-3- Phenylpropyl)Norephedrine; P-Hydroxy-N-(1-Methyl-3- 447-41-6 Buphenine Hydrochloride Phenylpropyl) Norphedrine;

40

Bupivacaine Hydrochloride 1-Butyl-N-(2,6-Dimethylphenyl)-2-Piperidinecarboxamide; 73360-54-0 Monohydrate

Bupropion USP Related Compound B 1049718-43-5

Bupropion USP Related Compound A 1049718-72-0

Bupropion USP Related Compound E 10557-17-2

Bupropion 3,4-Dichloro Impurity 1193779-34-8 Bupropion

Bupropion 3,5-Dichloro Impurity 1193779-48-4

Bupropion amino -Bupropion Amino Impurity 119802-69-6

Bupropion Hydrochloride -1-(3-Chlorophenyl)-2- 31677-93-7 [(1,1-Dimethylethyl)Amino]-1-Propanone Hydrochloride

8-[4-[4-(2-Pyrimidinyl)-1-Piperazinyl]Butyl]-8-Azaspiro 33386-08-2 Buspirone Hydrochloride [4.5]Decane-7,9-Dione; Ansial;

Butetamate Citrate; 13900-12-4 Butetamate Citrate

4-Hydroxybenzoic Acid Butyl Ester; Butyl 94-26-8 4-(Butoxycarbonyl)Phenol; Parahydroxybenzoate

(1,1-Dimethylethyl)-4-Methoxyphenol; 25013-16-5 Butylhydroxyanisole 2(3)-Tert-Butyl-4-Hydroxyanisole;

2,6-Bis(1,1-Dimethylethyl)-4-Methylphenol; 128-37-0 Butylhydroxytoluene

41

(ΑR,ΒS)-Β-[[ (1,1-Dimethylethoxy) Carbonyl]Amino] -Α-Hydroxybenzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS) -12b-(Acetyloxy) -12-(Benzoyloxy) 183133-96-2 Cabazitaxel -2a,3,4,4a,5,6,9,10,11,12,12a,12b- Dodecahydro-11-Hydroxy-4, 6-Dimethoxy-4a,8,13,13- Tetramethyl-5-Oxo-7,11-Met

CI-103N-[4-(3-Chloro-4-Fluorophenylamino)-7- (3-Morpholin-4-Ylpropoxy)Quinazolin-6-Yl]Acrylamide 289499-45-2 Canertinib Dihydrochloride Dihydrochloride

Capecitabine impurity D 161599-46-8 Capecitabine

10,11-dihydro-10,11-dioxo carbamazepine 537693-29-1 Carbamazepine

Carglumic acid Impurity 1188-38-1 Carglumic Acid

Cetirizine N-Oxide 1076199-41-1 Cetirizine Cetirizine EP Impurity B 83881-51-0

4-Chlorobenzotrifluoride 98-56-6 Chlorobenzotrifluoride

Ciprofloxacin EP Impurity B 93107-11-0 Ciprofloxacin

Citalopram Impurity B 411221-53-9 Citalopram Citalopram Impurity A 64372-56-1

Clonazepam Impurity - A,B 55198-89-5 Clonazepam

42

Clonazepam Impurity A 55198-89-5

Clopidogrel Impurity 113665-84-2 Clopidogrel Clopidogrel Related compound C 120202-71-3

Clotrimazole EP Impurity D 288-32-4 Clotrimazole Clotrimazole EP Impurity C 42074-68-0

Darifenacin Bromo Impurity 127264-14-6 Darifenacin Darifenacin Carboxylic Acid Impurity 69999-16-2

Debenzyl Donepezil 120013-39-0 Debenzyl

Dehydro Aripiprazole Impurity 1008531-60-9 Dehydro Aripiprazole

Desloratadine impurity A 38092-95-4

Dehydro Desloratidine 117811-20-8

Desloratadine Impurity 100643-71-8 Desloratadine Desloratadine N-acyl 117796-52-8

Desloratadine N-Acetyl Impurity 117796-52-8

N-Formyl Desloratadine 117810-61-4

43

Desloratadine N-hydroxy 1193725-73-3

Desloratadine N-Hydroxy Impurity 1193725-73-3

Desloratadine 3-hydroxy 119410-08-1

Dexpramipexole Dexpramipexole Dihydrochloride Impurity 104632-27-1 Dihydrochloride

Dipyramidole Impurity D 1176886-12-6 Dipyramidole

Domperidone N-Oxide 118435-03-3 Domperidone

Donepezil Impurity VI 120012-04-6

Donepezil Deoxy Impurity 1034439-57-0

Donepezil N-oxide 120013-84-5 Donepezil

Donepezil Dihydro Impurity 120012-04-6

Donepezil Dehydro Deoxy Impurity 120013-45-8

DORZOLAMIDE Related Compound B 120279-37-0 Dorzolamide

Duloxetine Impurity EP F 116817-28-8 Duloxetine Duloxetine Impurity F 116817-28-8

Etofenamate Impurity C 101-23-5 Etofenamate

44

Famciclovir Impurity 104227-87-4 Famciclovir

4-(2,3-Dichlorophenyl)-1,4-Dihydro-2,6-Dimethyl-3, 5-Pyridinedicarboxylic Acid Ethyl Methyl Ester; 72509-76-3 Felodipine Feloday; Flodil;

Glibenclamide Impurity 10238-21-8 Glibenclamide

Ibuprofen Impurity B 3585-49-7 Ibuprofen

4-[(4-Methylpiperazin-1-Yl)Methyl]-N-(4-Methyl-3- {[4-(Pyridin-3-Yl)Pyrimidin-2-Yl]Amino}Phenyl) 152459-95-5 Imatinib Benzamide;

Dabigatran Isopropyll Ester Impurity 211915-06-9 Isopropyl Ester

Isorizatriptan 208941-96-2 Isorizatriptan

Lacidipine Impurity 103890-78-4 Lacidipine

Lansoprazole Impurity 103577-45-3 Lansoprazole

Lercanidipine Impurity B 1119226-97-9 Lercanidipine

Letrozole Impurity 113402-31-6 Letrozole

Levetiracetam Impurity 102767-28-2 Levetiracetam

Lidocaine Impurity K 50295-20-0 Lidocaine Lidocaine Impurity - A,C,H,D,F,G,I,J,K 50295-20-0

45

Lisinopril cyclohexyl analogue 1132650-67-9 Lisinopril Lisinopril Dihydrate EP Impurity 1012-05-1

Lopinavir EP Impurity T 192725-17-0 Lopinavir

3-Hydroxy loratadine 183483-15-0

4-Hydroxymethyl loratadine 609806-40-8 Loratadine Loratadine USP RC A 100643-71-8

Loratadine EP Impurity F 125743-80-8

Losartan Impurity J 1006062-27-6

Losartan Carboxylic Acid 124750-92-1 Losartan

Losartan Impurity H 124751-00-4

Maleic acid 110-16-7 Maleic acid

Masalazine Impurity L 118-91-2 Masalazine

Metoprolol Impurity O (EP) 154784-36-8 Metoprolol Metoprolol Impurity A 109632-08-8

Metronidazol Impurity G 1010-93-1 Metronidazol

46

Modafinil Related Compound - A,B,C,D,E 63547-24-0

Modafinil Related Compound A 63547-24-0 Modafinil

Modafinil Related Compound B 118779-53-6

Moxifloxacin Impurity B 1029364-73-5 Moxifloxacin MoxifloxacinImpurity 1029364-77-9

Nateglinide Impurity 105816-04-4 Nateglinide

Nevirapine Impurity 129618-40-2 Nevirapine

Nortriptyline Impurity C 1156-99-6 Nortriptyline

Ofloxacin Impurity B 123155-82-8 Ofloxacin

Olanzapine EP Impurity B 221176-49-4

Olanzapine EP Impurity C 719300-59-1 Olanzapine Olanzapine Lactam 1017241-34-7

Olanzapine Thiolactam Impurity 1017241-36-9

Omeprazole Hydrolysis Impurity 1227380-90-6 Omeprazole

Ondansetron EP Impurity H 9614-14-9 Ondansetron

47

Ondansetron Hydrochloride Dihydrate 103639-04-9

Ondansetron EP Impurity A 119812-29-2

Oseltamivir EP Impurity H 814-29-9 Oseltamivir

Oxeladine Impurity A (EP) - Oxeladine

Oximinostilbene - Oximinostilbene

Oxybutynin Impurity A 1199574-71-4 Oxybutynin

Pantoprazole Impurity B 102625-64-9

Pantoprazole Impurity A 127780-16-9 Pantoprazole

Pantoprazole Sulfone 127780-16-9

Paroxetine Impurity C 105813-13-6 Paroxetine

Piroxicam Impurity L 118854-48-1 Piroxicam

Pramipexole EP Impurity E 105816-05-5

Pramipexole EP Impurity A 106092-09-5 Pramipexole

Pramipexole EP Impurity B 1246815-83-7

rac 4,5-Dehydro Pregabalin 216576-74-8 Pregabalin

48

Propafenone Impurity E 165279-79-8 Propafenone

Propranolol Impurity C (EP) - Propranolol

Prulifloxacin Impurity 123447-62-1 Prulifloxacin

Quetipine Hemifumarate Impurity 111974-72-2 Quetipine Hemifumarate

Rivastigmine tartarate working standard 123441-03-2 Rivastigmine

3 Oxo Ropinirole Impurity 102842-51-3

Ropinirole N-Oxide 1070377-34-2 Ropinirole

Ropinirole Hcl -N-Despropyl Ropinirole HCl 106308-44-5

Rosuvastatin calcium diastereomer / Rosuvastatin 1093959-75-1 Rosuvastatin Calcium

Rufinamide Impurity 106092-09-5 Rufinamide

Simvastatin anhydro Impurity C 210980-68-0 Simvastatin Simvastatin Impurity A -

Zoledronic Acid Impurity 118072-93-8 Soledronic

Telmisartan Impurity B 1026438-56-1 Telmisartan

Tranexamic acid Impurity A - Tranexamic acid

49

Tropicamide Impurity A 33403-97-3 Tropicamide

[3-[[2-Methoxy-4-[[[ (2-Methylphenyl)Sulfonyl]Amino] Carbonyl]Phenyl]Methyl]-1-Methyl -1H-Indol-5-Yl] 107753-78-6 Zafirlukast Carbamic Acid Cyclopentyl Ester

N-[3-(3-Cyanopyrazolo[1,5-A]Pyrimidin-7-Yl)Phenyl] 151319-34-5 Zaleplon -N-Ethylacetamide; CL-284846; Sonata

API IMPURITIES

Top of Form

Bottom of Form

API IMPURITIES PRODUCTS LIST

Impurity Name CAS No. Product Name

1,6- Dibromohexane 629-03-8 1, 6- Dibromohexane

(1S,4R)-4-[2-Amino-6-(Cyclopropylamino)-9H-Purin-9-Yl]-2- 136470-78-5 Abacavir Cyclopentene-1-Methanol

Avermectin B1; MK-936; Agri-Mek; Avid; Zephyr; 71751-41-2 Abamectin

(1R,4aR,4bR,10aR)-1,2,3,4,4a,4b,5,6,10,10a-Decahydro-1,4a- Dimethyl-7-(1-Methylethyl)-1-Phenanthrenecarboxylic 514-10-3 Abietic Acid Acid;

50

(3β)-17-(3-Pyridinyl)Androsta-5,16-Dien-3-Ol 154229-18-2 Abiraterone Acetate Acetate (Ester); CB 7630;

2-(4-Methoxyphenyl)-5, 7-Dihydroxy-4H-1-Benzopyran-4-One; 480-44-4 Acacetin 4’-O-Methylapigenin;

5-Aminoimidazole-4-Carboxamide-1-Β-D-Ribofuranoside; 2627-69-2 Acadesine

O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6 -Trihydroxy-3-(Hydroxymethyl)-2-Cyclohexen-1-Yl] 56180-94-0 Acarbose Amino]-Α-D-Glucopyranosyl-(1→4)-O-Α-D -Glucopyranosyl-(1→4)-D-Glucose;

Ambroxol Theophylline-7-Acetic Acid; 179118-73-1 Acebrophylline

N-[3-Acetyl-4-[2-Hydroxy-3-[(1-Methylethyl)Amino] 34381-68-5 Acebutolol Hydrochloride Propoxy]Phenyl]Butanamide Hydrochloride;

Aceclofenac Impurity F (EP) 100499-89-6

Aceclofenac Aceclofenac (WS); 2-[(2,6-Dichlorophenyl)-Amino] 89796-99-6 Benzeneacetic Acid Carboxymethyl Ester;

4-(Acetylamino)Benzoic Acid; 4-Acetamidobenzoic Acid 556-08-1 Acedoben

Theophylline-7-Acetic Acid; 1,2,3,6-Tetrahydro-1,3-Dimethyl 652-37-9 Acephylline -2,6-Dioxo-7H-Purine-7-Acetic Acid;

Ethanimidamide Hydrochloride; 124-42-5 Acetamidine Hydrochloride

N-(4-Hydroxyphenyl)Acetamide; 103-90-2 Acetaminophen

51

N-[5-Aminosulfonyl)-1,3,4-Thiadiazol-2-Yl]Acetamide; 59-66-5 Acetazolamide

N-Hydroxyacetamide; Ethanehydroxamic Acid; AHA; Acetic Acid Oxime; Acetohydroximic Acid; 546-88-3 Acetohydroxamic Acid Acetylhydroxamic Acid;

N-Acetyl-L-Cysteine; ACC; Acetadote; 616-91-1 Acetylcysteine

2-Acetoxybenzoic Acid; 2-(Acetyloxy)Benzoic Acid; 50-78-2 Acetylsalicylic acid Acylpyrin; Angettes; Aspro; Aspirin; ASA;

10-Azaanthracene; 2,3-Benzoquinoline; 260-94-6 Acridine

2-Amino-1, 59277-89-3 Acyclovir 9-Dihydro-9-[(2-Hydroxyethoxy)Methyl]-6H-Purin-6-One;

Tricyclo[3.3.1.1(3,7)]Decan-1-Amine; 1-Adamantanamine; Adamantamine; Adamantanamine; 768-94-5 Adamantamine Adamantylamine;

6-(4-Methoxy-3-Tricyclo[3.3.1.13,7]Dec-1-Ylphenyl)- 106685-40-9 Adapalene 2-Naphthalenecarboxylic Acid;

P’-[[2-(6-Amino-9H-Purin-9-Yl)Ethoxy]Methyl] Adefovir Phosphate - Isohypophosphoric Acid Triethylamine Salt; Triethylamine

9-Β-D-Ribofuranosyl-9H-Purin-6-Amine; 58-61-7 Adenosine

(6S,7S)-7-[(Hydroxyamino)Carbonyl]-6- [(4-Phenyl-1-Piperazinyl)Carbonyl]-5-Azaspiro[2.5] 791828-58-5 Aderbasib Octane-5-Carboxylic Acid Methyl Ester; INCB 007839;

52

Α-Phenylbenzeneacetic Acid 2-(Diethylamino)Ethyl Ester 50-42-0 Adiphenine Hydrochloride Hydrochloride

(−)-Epinephrine (+)-Bitartrate Salt; L-3,4-Dihydroxy-Α-(Methylaminomethyl)Benzyl 51-42-3 Adrenaline Tartrate Alcohol D-Hydrogen Bitartrate Salt;

Escin; Aescin; Chestnuts Extract; 11072-93-8 Aescin

Aflatoxin B1; (6aR,9aS)-2,3,6a,9a-Tetrahydro- 4-Methoxy-1H,11H-Cyclopenta[C]Furo[3’,2’:4,5] 1162-65-8 Aflatoxin Furo[2,3-H][1]Benzopyran-1,11-Dione;

6-Amino-2-(Fluoromethyl)-3-(2-Methylphenyl)- 56287-74-2 Afloqualone Quinazolin-4-One

N-[2-(7-Methoxy-1-Naphthalenyl)Ethyl]Acetamide; N-[2-(7-Methoxy-1-Naphthyl) Ethyl]Acetamide; 138112-76-2 Agomelatine S 20098; Valdoxan;

DL-Alanine; (R,S)-Alanine; 302-72-7 Alanine

N-[6-(Propylthio)-1H-Benzimidazol-2-Yl]Carbamic Acid Methyl Ester; [5-(Propylthio)-1H-Benzimidazol-2-Yl] 54965-21-8 Albendazole Carbamic Acid Methyl Ester; Albenza; Andazol;

Salbutamol Sulphate; Α1-[[(1,1-Dimethylethyl)Amino]Methyl] 51022-70-9 Albuterol Sulfate -4-Hydroxy-1,3-Benzenedimethanol Sulfate; Aerolin;

6,11-Dihydro-11-(1-Methyl-4-Piperidinylidene)- 5H-Imidazo[2,1-B][3]Benzazepine-3-Carboxaldehyde; 147084-10-4 Alcaftadine R 89674

(11β)-11,21-Dihydroxy-3,20-Dioxopregn-4-En-18-Al; 52-39-1 Aldosterone

53

N-[3-[(4-Amino-6,7-Dimethoxy-2-Quinazolynyl) 81403-68-1 Alfuzosin Hydrochloride Methylamino]Propyl]Tetrahydro-2-Furancarboxamide;

5,5-Diallybarbituric Acid; 5,5-Di-2-Propenyl-2,4,6 52-43-7 Allobarbital (1H,3H,5H)Pyrimidinetrione; Allobarbitone

1,5-Dihydro-4H-Pyrazolo[3,4-D]Pyrimidin-4-One; 1H-Pyrazolo(3,4-D)Pyrimidin-4-Ol; 315-30-0 Allopurinol 4-Hydroxypyrazolo(3,4-D)Pyrimidine; 4-Hydroxypyrazolo[3,4-D]Pyrimidine; HPP

8-Chloro-1-Methyl-6-Phenyl-4H-[1,2,4] Triazolo[4,3-A][1,4]Benzodiazepine; 8-Chloro-1-Methyl-6-Phenyl-4H-S-Triazolo[4,3-A][1,4] 28981-97-7 Alprazolam Benzodiazepine; Tensivan; Trankimazin; Tranquinal; Tricalma; U 31889; Valeans; Xanagis; Xanax; Xanax TS; Xanolam; Xanor; Zolam; Zo

N-Ethyl-N-(3-Phenylpropyl)Benzenepropanamine 5560-59-8 Alverine Citrate 2-Hydroxy-1,2,3- Propanetricarboxylate;

Tricyclo[3.3.1.13,7]Decan-1-Amine Hydrochloride 665-66-7 Amantadine Hydrochloride

4-[[(2-Amino-3,5-Dibromophenyl)Methyl]Amino] 23828-92-4 Ambroxol Hydrochloride Cycophexanol Hydrochloride;

N-Amidino-3,5-Diamino-6-Chloropyrazinecarboxamide Amiloride Hydrochloride 17440-83-4 Hydrochloride Dihydrate; Dihydrate

(2-Butyl-3-Benzofuranyl)[4-[2-(Diethylamino)Ethoxy] 19774-82-4 Amiodarone Hydrochloride -3,5-Diiodophenyl]Methanone Hydrochloride;

4-Amino-N-[(1-Ethyl-2-Pyrrolidinyl)Methyl]-5- (Ethylsulfonyl)-2-Methoxybenzamide; Aminosultopride; 71675-85-9 Amisulpride DAN-2163; Socian; Solian; Sulamid;

54

N’-(2,4-Dimethylphenyl)-N-[[(2,4-Dimethylphenyl)Imino] 33089-61-1 Amitraz Methyl]-N-Methyl-Methanimidamide;

3-(10,11-Dihydro-5H-Dibenzo[A,D]Cyclohepten-5-Ylidene) 549-18-8 Amitriptyline Hydrochloride -N,N-Dimethyl-1-Propanamine Hydrochloride

Amlodipine EP Impurity I, Amlodipine Besilate - 2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-1,4 111470-99-6 -Dihydro-6-Methyl-3,5-Pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester Benzenesulfonate;

Amlodipine Impurity D (EP) 113994-41-5

2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-3- Ethoxycarbonyl-5-Methoxycarbonyl)-6-Methyl-1,4 88150-42-9 Amlodipine -Dihydropyridine;

Amlodipine EP Impurity G 43067-01-2

Amlodipine Maleate - Diethyl 2-((2-Aminoethoxy)Methyl)-4-(2-Chlorophenyl) 1357024-06-6 -6-Methyl-1,4-Dihydropyridine-3,5-Dicarboxylate Maleate;

Amlodipine Mesilate; 246852-12-0

4-[(7-Chloro-4-Quinolinyl)Amino]-2-[(Diethylamino)Methyl] Amodiaquine 6398-98-7 Phenol Dihydrochloride; Dihydrochloride Dihydrate

5-Amino-2-[2-(Dimethylamino)Ethyl]-1H-Benz[De] 69408-81-7 Amonafide Isoquinoline-1,3(2H)-Dione;

Amoxicillin; 61336-70-7 Amoxicillin Trihydrate (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-Hydroxyphenyl)Acetyl]

55

Amino]-3,3-Dimethyl-7-Oxo-4-Thia-1-Azabicyclo[3.2.0] Heptane-2-Carboxylic Acid;

Ampicillin Sodium - D-(-)-6-(2-Amino-2-Phenylacetamido)-3,3-Dimethyl -7-Oxo-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 69-52-3 Acid Monosodium Salt; Binotal Sodium; Britapen Injection; Cilleral; D-Α-Aminobenzylpenicillin Sodium Salt; Ampicillin Ampicillin Sodium Salt; Ampicillin-Na; Ampicin

Ampicillin Trihydrate - D-(−)-Α-Aminobenzylpenicillin; 7177-48-2

Anastrozole Impurity E 1027160-12-8

Anastrozole Impurity 120511-73-1

Anastrozole Impurity D 120511-84-4 Anastrozole

Anastrozole Impurity B 1215780-15-6

Anastrozole Impurity C 1216898-82-6

(5α,17β)-17-Hydroxyandrostan-3-One; 521-18-6 Androstanolone Dihydrotestosterone; 5α-Dihydrotestosterone; Stanolone;

3α-Hydroxy-5α-Androstan-17-One, 53-41-8 Androsterone 5α-Androstan-3α-Ol-17-One;

1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(Pentyloxy) [1,1':4',1"-Terphenyl]-4-Yl]Carbonyl]-L-Ornithine] 166663-25-8 Anidulafungin Echinocandin B; Ecalta; Eraxis; LY 303366;

Antazoline Hydrochloride - 4,5-Dihydro-N-Phenyl-N- 2508-72-7 Antazoline (Phenylmethyl)-1H-Imidazole-2-Methanamine

56

Hydrochloride 4,5-Dihydro-N-Phenyl-N-(Phenylmethyl) -1H-Imidazole-2-Methanamine Monohydrochloride

Antazoline Phosphate - Antistine Phosphate; 154-68-7 2-[(N-Benzylanilino)Methyl]-2-Imidazoline Phosphate;

5,7-Dihydroxy-2-(4-Hydroxyphenyl)-4H-1- Benzopyran-4-One; 4’,5,7-Trihydroxyflavone; 520-36-5 Apigenin Pelargidenon 1449

(6aR)-5,6,6a,7-Tetrahydro-6-Methyl-4H-Dibenzo[De,G] Apomorphine 41372-20-7 Quinoline-10,11-Diol Hydrochloride Hemihydrate Hydrochloride Hemihydrate

N1-(2,3-Dihydro-1H-Inden-2-Yl)-N3,N3-Diethyl-N1- 33237-74-0 Aprindine Hydrochloride Phenyl-1,3-Propanediamine Hydrochloride;

(5Z,8Z,11Z,14Z)-5,8,11,14-Eicosatetraenoic Acid; 506-32-1 Arachidonic Acid

1,2,5,6-Tetrahydro-1-Methyl-3-Pyridinecarboxylic 300-08-3 Arecoline Hydrobromide Acid Methyl Ester Hydrobromide;

(2R,4R)1-[(2S)2-Amino-5-[[Imino(Nitroamino)Methyl] Amino]-1-Oxopentyl]-4-Methyl-2-Piperidinecarboxylic 74874-08-1 Argatroban Acid Ethyl Ester Hydrochloride; Argatroban Intermediate;

Arginine - L-Arginine; Arginine; Argivene; Detoxargin; 74-79-3 L-(+)-Arginine; Arginine Arginine Hydrochloride - L-Arginine Hydrochloride; 1119-34-2 L-Arginine Monohydrochloride;

Argirelin Acetate(Acetyl Hexapeptide-3); 616204-22-9 Argireline Acetate

57

Aripiprazole Impurity D 882880-12-8

Aripiprazole Impurity E 120004-79-7 Aripiprazole

Aripiprazole - 7-[4-[4-(2,3-Dichlorophenyl)-1-Piperazinyl] 129722-12-9 Butoxy]-3,4-Dihydro-2(1H)-Quinolinone;

8-Methoxybenzo[F]-1,3-Benzodioxolo[6,5,4-Cd]Indol- 13395-02-3 Aristolactam 5(6H)-One; Aristolactam

Butanedioic Acid Mono(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-3,6 88495-63-0 Artesunate ,9-Trimethyl-3,12-Epoxy-12H-Pyrano[4,3-J]-1,2- Benzodioxepin-10-Yl] Ester; Artesunic Acid

Carticaine Hydrochloride; 4-Methyl-3-[2-(Propylamino) Propionamido]-2-Thiophenecarboxylic Acid Methyl 23964-57-0 Articaine Hydrochloride Ester Hydrochloride;

Changchuanmycin; Immunomycin; FK 520; FR 520; 104987-12-4 Ascomycin FR 900520; L 683590;

L-Ascorbic Acid; (+)-Ascorbic Acid; 100M; 50-81-7 Ascorbic Acid L-Threo-Ascorbic Acid;

Asenapine N-oxide Impurity 128949-51-9

Asenapine (3aR,12bR)-Rel-5-Chloro-2,3,3a,12b-Tetrahydro-2- 65576-45-6 Methyl-1H-Dibenz[2,3:6,7]Oxepino[4,5-C]Pyrrole;

L-Α-Aspartyl-L-Phenylalanine 2-Methyl Ester; Canderel; 22839-47-0 Aspartame

58

(S)-(+)-Aminosuccinic Acid; (S)-Aminobutanedioic Acid; 56-84-8 Aspartic acid L-Aspartic Acid;

Aspirin Impurity - A,D,F,C 99-96-7 Aspirin Aspirin Impurity A (EP) 99-96-7

1-[(4-Fluorophenyl)Methyl]-N-[1-[2-(4-Methoxyphenyl) 68844-77-9 Astemizole Ethyl]-4-Piperidinyl]-1H-Benzimidazol-2-Amine;

Atenolol Impurity C 29122-69-8

Atenolol Impurity - H,F 87619-83-8 Atenolol

4-[2-Hydroxy-3-[(1-Methylethyl)Amino]Propoxyl] 29122-68-7 Benzeneacetamide;

Atorvastatin methyl ester 345891-62-5

Atorvastatin ethyl ester 1146977-93-6

Atorvastatin Impurity H (EP) 125995-03-1 Atorvastatin

Atorvastatin Lactone 125995-03-1

Atorvastatin Acid - (3R,5R)-2-(4-Fluorophenyl)-3,5-Dihydroxy-5- 134523-00-5 (1-Methylethyl)-3-Phenyl-4-[(Phenylamino)Carbonyl] -1H-Pyrrole-1-Heptanoic Acid ;

Atovaquone methyl ether 129700-41-0 Atovaquone methyl ether

59

2,2’-[1,5-Pentanediylbis[Oxy(3-Oxo-3,1-Propanediyl)]] Bis[1-[(3,4-Dimethoxyphenyl)Methyl]-1,2,3,4-Tetrahydro- 64228-81-5 Atracurium Besylate 6,7-Dimethoxy-2-Methyl-Isoquinolinium Benzenesulfonate;

(RS)-(8-Methyl-8-Azabicyclo[3.2.1]Oct-3-Yl) 51-55-8 Atropine 3-Hydroxy-2-Phenylpropanoate;

1-[4-(1,1-Dimethylethyl)Phenyl]-3-(4-Methoxyphenyl)- 70356-09-1 Avobenzone 1,3-Propanedione;

Nonanedioic Acid; Azelate; Nonanedioate 123-99-9 Azelaic Acid

Azelastine Impurity-B 110406-94-5 Azelastine

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3, 4,10-Trihydroxy-3,5,6,8,10,12,14-Heptamethyl-15-Oxo- 11- {[3,4,6-Trideoxy-3-(Dimethylamino)-Β-D-Xylo- 83905-01-5 Azithromycin Hexopyranosyl]Oxy}-1-Oxa-6-Azacyclopentadec-13-Yl 2,6-Dideoxy-3-C-Methyl-3-O-Methyl-Α-L-Ribo -Hexopyranoside;

[2S-[2α,3β(Z)]]-2-[[(Z)-[1-(2-Amino-4-Thiazolyl)-2- [[(2S,3S)-2-Methyl-4-Oxo-1-Sulfo-3-Azetidinyl]Amino]- 78110-38-0 Aztreonam 2-Oxoethylidene]Amino]Oxy]-2-Methylpropanoic Acid;

(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-Bis (Acetyloxy)-12-(Benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12 ,12a,12b-Dodecahydro-4,9,11-Trihydroxy-4a,8,13,13 27548-93-2 Baccatin III -Tetramethyl-7,11-Methano-5H-Cyclodeca[3,4]Benz [1,2-B]Oxet-5-One;

5-[(1E)-2-[4-[[(2-Carboxyethyl)Amino]Carbonyl]Phenyl] 80573-04-2 Balsalazide Diazenyl]-2-Hydroxybenzoic Acid;

60

Balsalazide Disodium - 5-[(1E)-[4-[[(2-Carboxyethyl) Amino]Carbonyl]Phenyl]Azo]-2-HydroxyBenzoic Acid, 150399-21-6 -, Disodium Salt, Dihydrate (9CI);

1,2-Bis(2-Aminophenoxy)Ethane-N,N,N’,N’-Tetraacetic Acid; N,N'-[1,2-Ethanediylbis(Oxy-2,1-Phenylene)] 85233-19-8 BAPTA Bis[N-(Carboxymethyl)Glycine; BAPTA;

9α-Chloro-16β-Methylprednisolone 17,21-Dipropionate; Beclomethasone 5534-09-8 Aerobec; Aldecin; Beclometasone Dipropionate Dipropionate

(3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-Phenylpropyl]Amino]- 2,3,4,5-Tetrahydro-2-Oxo-1H-1-Benzazepine-1-Acetic 86541-74-4 Benazepril Hydrochloride Acid Hydrochloride; Lotensin;

5-[Bis(2-Chloroethyl)-Amino]-1-Methyl-1H-Benzimidazole-2 Bendamustine -Butanoic Acid Hydrochloride; Cytostasan; Ribomustin; 3543-75-7 Hydrochloride Treanda

1-[1-[4-(4-Fluorophenyl)-4-Oxobutyl]-4-Piperidinyl]-1,3- Dihydro-2H-Benzimidazol-2-One; 1-[1-[3-(P-Fluorobenzoyl) 2062-84-2 Benperidol Propyl]-4-Piperidyl]-2-Benzimidazolinone;

6-Hydroxy bentazone 60374-42-7 Bentazone

Alkyldimethylbenzylammonium Chloride; Arquad CB 30; BTC; BTC 2565; BTC 471; Benzalkon A; Benzalkonium Chloride; Biowash; Cedium; Culversan LC 80; 8001-54-5 Benzalkonium Chloride Dimanin A; Erional EL; Genamin KDS; Kemamine BAC; Konrapo; Leda Benzalkonium Chloride; Magna M 407;

Rac Xanthoanthrafil; N-[(3,4-Dimethoxyphenyl)Methyl]-2- 1020251-53-9 Benzamidenafil [(2-Hydroxy-1-Methylethyl)Amino]-5-Nitro-Benzamide;

61

(3,5-Dibromo-4-Hydroxyphenyl)(2-Ethyl-3- Benzofuranyl)Methanone; 3,5-Dibromo-4-Hydroxyphenyl 2-Ethyl- 3562-84-3 Benzbromarone 3-Benzofuranyl Ketone

Benzene Sulphonic Acid; Benzenesulphonic Acid; Phenylsulfonic 98-11-3 Benzenesulfonic Acid Acid; Phenylsuphonic Acid;

Α-Phenyl-Benzenemethanamine; 1-Amino-1- 91-00-9 Benzhydrylamine (Phenylmethyl)Benzene;

1,3-Benzodiazole; BZI; 1H-Benzoimidazole; 51-17-2 Benzimidazole

4-Aminobenzoic Acid Ethyl Ester; P-Aminobenzoic Acid 94-09-7 Benzocaine Ethyl Ester; Ethyl 4-Aminobenzoate; Anaesthan-Syngala

Benzotropine Mesylate; Cogentin; Cogentinol; Benztropine 132-17-2 Benztropine Mesylate Methanesulfonate;

N,N-Dimethyl-3-[[1-(Phenylmethyl)-1H-Indazol-3-Yl]Oxy] 132-69-4 Benzydamine Hydrochloride -1-Propanamine Hydrochloride;

Benzyl Alcohol -Α-Toluenol; (Hydroxymethyl)Benzene; 100-51-6 Benzenecarbinol;

Benzyl Benzoate - Benzyl Ester Benzoic Acid; Ascabin; Ascabiol; Benylate; Benzyl Benzenecarboxylate; Scobenol; 120-51-4 Vanzoate; Venzonate; Benzyl

Benzyl Chloride - 6-(Chloromethyl)Benzene; 100-44-7 Α-Chlorotoluene;

Benzyl Nicotinate - Nicotinic Acid Benzyl Ester; 94-44-0

62

Benzathine Benzylpenicillin; 1538-09-6

Benzyl Penicillinate Potassium Salt; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(2-Phenylacetyl) Amino]-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 113-98-4 Acid Potassium Salt; Potassium Benzylpenicillin; Potassium Benzylpenicillinate;

Procaine Benzylpenicillin; (2S,5R,6R)-3,3-Dimethyl-7-Oxo-6-[(Phenylacetyl)Amino] -4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylic 6130-64-9 Acid Compd. With 2-(Diethylamino)Ethyl 4-Aminobenzoate Hydrate;

4-[(S)-(4-Chlorophenyl)-2-Pyridinylmethoxy]-1- Piperidinebutanoic Acid Benzenesulfonate; Bepreve; 190786-44-8 Bepotastine Besylate TAU 284; Talion;

Dl-4-[(1R,2R,3aS,8bS)-2,3,3a,8b-Tetrahydro-2-Hydroxy- [(3S,4RS)-3-Hydroxy-4-Methyl-Oct-6-Yne-(E)-1-Enyl]- 88475-69-8 Beraprost Sodium 5-Cyclopenta[B]Benzofuranyl]Butanoic Acid Sodium

4-[[(2E)-3,7-Dimethyl-2,6-Octadien-1-Yl]Oxy]-7H-Furo 7380-40-7 Bergamottin [3,2-G][1]Benzopyran-7-One

N-Methyl-2-Pyridineethanamine Dihydrochloride; 5579-84-0 Betahistine Dihydrochloride Sinmenier; Vasomotal;

N-(Methyl-D3)-2-Pyridineethanamine Hydrochloride; 15430-48-5 Betahistine Hydrochloride

1-Carboxy-N,N,N-Trimethyl-Methanaminium Inner Salt; (Carboxymethyl)Trimethylammonium Hydroxide Inner Salt; (Trimethylammonio)Acetate; Abromine; Aminocoat; 107-43-7 Betaine Aquadew AN 100; Betafin; Betafin BCR; Betafin BP; Betafin BP 20; Cystadane;

63

Betamethasone - (11β,16β)-9-Fluoro-11,17,21-Trihydroxy-16- 378-44-9 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Acetate - Betamethasone 21-Acetate; (11β,16β)-21-(Acetyloxy)-9-Fluoro-11,17-Dihydroxy-16- 987-24-6 Methylpregna-1,4-Diene-3,20-Dione

Betamethasone Betamethasone Dipropionate - (11β,16β)-9-Fluoro-11- Hydroxy-16-Methyl-17,21-Bis(1-Oxopropoxy)-Pregna-1, 5593-20-4 4-Diene-3,20-Dione;

Betamethasone Sodium Phosphate - Betamethasone 21-Phosphate Disodium Salt; (11β,16β)-9-Fluoro-11, 151-73-5 17-Dihydroxy-16-Methyl-21-(Phosphonooxy)Pregna-1,4- Diene-3,20-Dione Sodium Salt;

1-[4-[2-(Cyclopropylmethoxy)Ethyl]Phenoxy]-3- 63659-19-8 Betaxolol Hydrochloride [(1-Methylethyl)Amino]-2-Propanol Hydrochloride;

2-[4-[2-[(4-Chlorobenzoyl)Amino]Ethyl]Phenoxyl]-2- 41859-67-0 Bezafibrate Methylpropanoic Acid; BM-15075;

Biapenem Impurity 120410-24-4 Biapenem

N-[4-Cyano-3-Trifluoromethyl)Phenyl]-3-[(4- 90357-06-5 Bicalutamide Fluorophenyl)Sulfonyl]- 2-Hydroxy-2-Methylpropanamide

4-Amino-5-Bromo-N-[2-(Diethylamino)Ethyl]-2- 4093-35-0 Bromopride Methoxybenzamide

Γ-(4-Bromophenyl)-N,N-Dimethyl-2- Pyridinepropanamine Maleate; 2-[P-Βromo-Α-[2-(Dimethylamino)Ethyl]Benzyl]Pyridine 980-71-2 Bromphen-iramine Maleate Maleate; (+/-)-Brompheniramine Maleate; Bromphen Maleate;

64

(RS)-1-[(4-Chlorophenyl)- Phenyl-Methyl]-4- 82-92-1 Buclizine [(4-Tert-Butylphenyl) Methyl] Piperazine;

(11β,16α)-16,17-[Butylidenebis(Oxy)]-11,21-Dihydroxypregna-1,4- 51333-22-3 Budesonide Diene-3,20-Dione;

4-Butoxy-N-Hydroxybenzeneacetamide; Parfenal; Trolab; P- Butoxyphenylacethydroxamic Acid; 2438-72-4 Bufexamac P-Butoxyphenylacetohydroxamic Acid;

4-(1-Pyrrolidinyl)-1-(2,4,6-Trimethoxyphenyl)-1-Butanone 35543-24-9 Buflomedil Hydrochloride Hydrochloride;

5-[3-[(1,1-Dimethylethyl)Amino]-2-Hydroxypropoxy]-3, 31969-05-8 Bunolol Hydrochloride 4-Dihydro-1(2H)-Naphthalenone Hydrochloride;

4-Hydroxy-Α-[1-[(1-Methyl-3-Phenylpropyl)Amino]Ethyl] Benzenemethanol; P-Hydroxy-N-(1-Methyl-3- Phenylpropyl)Norephedrine; P-Hydroxy-N-(1-Methyl-3- 447-41-6 Buphenine Hydrochloride Phenylpropyl) Norphedrine;

Bupivacaine Hydrochloride 1-Butyl-N-(2,6-Dimethylphenyl)-2-Piperidinecarboxamide; 73360-54-0 Monohydrate

Bupropion USP Related Compound B 1049718-43-5

Bupropion USP Related Compound A 1049718-72-0 Bupropion Bupropion USP Related Compound E 10557-17-2

Bupropion 3,4-Dichloro Impurity 1193779-34-8

65

Bupropion 3,5-Dichloro Impurity 1193779-48-4

Bupropion amino -Bupropion Amino Impurity 119802-69-6

Bupropion Hydrochloride -1-(3-Chlorophenyl)-2- 31677-93-7 [(1,1-Dimethylethyl)Amino]-1-Propanone Hydrochloride

8-[4-[4-(2-Pyrimidinyl)-1-Piperazinyl]Butyl]-8-Azaspiro 33386-08-2 Buspirone Hydrochloride [4.5]Decane-7,9-Dione; Ansial;

Butetamate Citrate; 13900-12-4 Butetamate Citrate

4-Hydroxybenzoic Acid Butyl Ester; Butyl 94-26-8 4-(Butoxycarbonyl)Phenol; Parahydroxybenzoate

(1,1-Dimethylethyl)-4-Methoxyphenol; 25013-16-5 Butylhydroxyanisole 2(3)-Tert-Butyl-4-Hydroxyanisole;

2,6-Bis(1,1-Dimethylethyl)-4-Methylphenol; 128-37-0 Butylhydroxytoluene

(ΑR,ΒS)-Β-[[ (1,1-Dimethylethoxy) Carbonyl]Amino] -Α-Hydroxybenzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS) -12b-(Acetyloxy) -12-(Benzoyloxy) 183133-96-2 Cabazitaxel -2a,3,4,4a,5,6,9,10,11,12,12a,12b- Dodecahydro-11-Hydroxy-4, 6-Dimethoxy-4a,8,13,13- Tetramethyl-5-Oxo-7,11-Met

CI-103N-[4-(3-Chloro-4-Fluorophenylamino)-7- (3-Morpholin-4-Ylpropoxy)Quinazolin-6-Yl]Acrylamide 289499-45-2 Canertinib Dihydrochloride Dihydrochloride

Capecitabine impurity D 161599-46-8 Capecitabine

66

10,11-dihydro-10,11-dioxo carbamazepine 537693-29-1 Carbamazepine

Carglumic acid Impurity 1188-38-1 Carglumic Acid

Cetirizine N-Oxide 1076199-41-1 Cetirizine Cetirizine EP Impurity B 83881-51-0

4-Chlorobenzotrifluoride 98-56-6 Chlorobenzotrifluoride

Ciprofloxacin EP Impurity B 93107-11-0 Ciprofloxacin

Citalopram Impurity B 411221-53-9 Citalopram Citalopram Impurity A 64372-56-1

Clonazepam Impurity - A,B 55198-89-5 Clonazepam Clonazepam Impurity A 55198-89-5

Clopidogrel Impurity 113665-84-2 Clopidogrel Clopidogrel Related compound C 120202-71-3

Clotrimazole EP Impurity D 288-32-4 Clotrimazole Clotrimazole EP Impurity C 42074-68-0

Darifenacin Bromo Impurity 127264-14-6 Darifenacin

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Darifenacin Carboxylic Acid Impurity 69999-16-2

Debenzyl Donepezil 120013-39-0 Debenzyl

Dehydro Aripiprazole Impurity 1008531-60-9 Dehydro Aripiprazole

Desloratadine impurity A 38092-95-4

Dehydro Desloratidine 117811-20-8

Desloratadine Impurity 100643-71-8

Desloratadine N-acyl 117796-52-8

Desloratadine N-Acetyl Impurity 117796-52-8 Desloratadine

N-Formyl Desloratadine 117810-61-4

Desloratadine N-hydroxy 1193725-73-3

Desloratadine N-Hydroxy Impurity 1193725-73-3

Desloratadine 3-hydroxy 119410-08-1

Dexpramipexole Dexpramipexole Dihydrochloride Impurity 104632-27-1 Dihydrochloride

Dipyramidole Impurity D 1176886-12-6 Dipyramidole

Domperidone N-Oxide 118435-03-3 Domperidone

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Donepezil Impurity VI 120012-04-6

Donepezil Deoxy Impurity 1034439-57-0

Donepezil N-oxide 120013-84-5 Donepezil

Donepezil Dihydro Impurity 120012-04-6

Donepezil Dehydro Deoxy Impurity 120013-45-8

DORZOLAMIDE Related Compound B 120279-37-0 Dorzolamide

Duloxetine Impurity EP F 116817-28-8 Duloxetine Duloxetine Impurity F 116817-28-8

Etofenamate Impurity C 101-23-5 Etofenamate

Famciclovir Impurity 104227-87-4 Famciclovir

4-(2,3-Dichlorophenyl)-1,4-Dihydro-2,6-Dimethyl-3, 5-Pyridinedicarboxylic Acid Ethyl Methyl Ester; 72509-76-3 Felodipine Feloday; Flodil;

Glibenclamide Impurity 10238-21-8 Glibenclamide

Ibuprofen Impurity B 3585-49-7 Ibuprofen

4-[(4-Methylpiperazin-1-Yl)Methyl]-N-(4-Methyl-3- {[4-(Pyridin-3-Yl)Pyrimidin-2-Yl]Amino}Phenyl) 152459-95-5 Imatinib Benzamide;

69

Dabigatran Isopropyll Ester Impurity 211915-06-9 Isopropyl Ester

Isorizatriptan 208941-96-2 Isorizatriptan

Lacidipine Impurity 103890-78-4 Lacidipine

Lansoprazole Impurity 103577-45-3 Lansoprazole

Lercanidipine Impurity B 1119226-97-9 Lercanidipine

Letrozole Impurity 113402-31-6 Letrozole

Levetiracetam Impurity 102767-28-2 Levetiracetam

Lidocaine Impurity K 50295-20-0 Lidocaine Lidocaine Impurity - A,C,H,D,F,G,I,J,K 50295-20-0

Lisinopril cyclohexyl analogue 1132650-67-9 Lisinopril Lisinopril Dihydrate EP Impurity 1012-05-1

Lopinavir EP Impurity T 192725-17-0 Lopinavir

3-Hydroxy loratadine 183483-15-0

4-Hydroxymethyl loratadine 609806-40-8 Loratadine

Loratadine USP RC A 100643-71-8

70

Loratadine EP Impurity F 125743-80-8

Losartan Impurity J 1006062-27-6

Losartan Carboxylic Acid 124750-92-1 Losartan

Losartan Impurity H 124751-00-4

Maleic acid 110-16-7 Maleic acid

Masalazine Impurity L 118-91-2 Masalazine

Metoprolol Impurity O (EP) 154784-36-8 Metoprolol Metoprolol Impurity A 109632-08-8

Metronidazol Impurity G 1010-93-1 Metronidazol

Modafinil Related Compound - A,B,C,D,E 63547-24-0

Modafinil Related Compound A 63547-24-0 Modafinil

Modafinil Related Compound B 118779-53-6

Moxifloxacin Impurity B 1029364-73-5 Moxifloxacin MoxifloxacinImpurity 1029364-77-9

Nateglinide Impurity 105816-04-4 Nateglinide

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Nevirapine Impurity 129618-40-2 Nevirapine

Nortriptyline Impurity C 1156-99-6 Nortriptyline

Ofloxacin Impurity B 123155-82-8 Ofloxacin

Olanzapine EP Impurity B 221176-49-4

Olanzapine EP Impurity C 719300-59-1 Olanzapine Olanzapine Lactam 1017241-34-7

Olanzapine Thiolactam Impurity 1017241-36-9

Omeprazole Hydrolysis Impurity 1227380-90-6 Omeprazole

Ondansetron EP Impurity H 9614-14-9

Ondansetron Hydrochloride Dihydrate 103639-04-9 Ondansetron

Ondansetron EP Impurity A 119812-29-2

Oseltamivir EP Impurity H 814-29-9 Oseltamivir

Oxeladine Impurity A (EP) - Oxeladine

Oximinostilbene - Oximinostilbene

Oxybutynin Impurity A 1199574-71-4 Oxybutynin

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Pantoprazole Impurity B 102625-64-9

Pantoprazole Impurity A 127780-16-9 Pantoprazole

Pantoprazole Sulfone 127780-16-9

Paroxetine Impurity C 105813-13-6 Paroxetine

Piroxicam Impurity L 118854-48-1 Piroxicam

Pramipexole EP Impurity E 105816-05-5

Pramipexole EP Impurity A 106092-09-5 Pramipexole

Pramipexole EP Impurity B 1246815-83-7

rac 4,5-Dehydro Pregabalin 216576-74-8 Pregabalin

Propafenone Impurity E 165279-79-8 Propafenone

Propranolol Impurity C (EP) - Propranolol

Prulifloxacin Impurity 123447-62-1 Prulifloxacin

Quetipine Hemifumarate Impurity 111974-72-2 Quetipine Hemifumarate

Rivastigmine tartarate working standard 123441-03-2 Rivastigmine

3 Oxo Ropinirole Impurity 102842-51-3 Ropinirole

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Ropinirole N-Oxide 1070377-34-2

Ropinirole Hcl -N-Despropyl Ropinirole HCl 106308-44-5

Rosuvastatin calcium diastereomer / Rosuvastatin 1093959-75-1 Rosuvastatin Calcium

Rufinamide Impurity 106092-09-5 Rufinamide

Simvastatin anhydro Impurity C 210980-68-0 Simvastatin Simvastatin Impurity A -

Zoledronic Acid Impurity 118072-93-8 Soledronic

Telmisartan Impurity B 1026438-56-1 Telmisartan

Tranexamic acid Impurity A - Tranexamic acid

Tropicamide Impurity A 33403-97-3 Tropicamide

[3-[[2-Methoxy-4-[[[ (2-Methylphenyl)Sulfonyl]Amino] Carbonyl]Phenyl]Methyl]-1-Methyl -1H-Indol-5-Yl] 107753-78-6 Zafirlukast Carbamic Acid Cyclopentyl Ester

N-[3-(3-Cyanopyrazolo[1,5-A]Pyrimidin-7-Yl)Phenyl] 151319-34-5 Zaleplon -N-Ethylacetamide; CL-284846; Sonata

API IMPURITIES

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API IMPURITIES PRODUCTS LIST

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