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List of European Pharmacopoeia Reference Standards

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List of European Pharmacopoeia Reference Standards Effective from 2021/9/29 Order Reference Standard Batch Quantity Sale Information Monograph Storage Shipping Shipment Price Code n° per vial Unit group with DGD Y0001552 Abacavir for peak identification CRS 1 10 mg 1 2589 +5°C+/-3°C A1A 79 € Y0001551 Abacavir for system suitability CRS 1 10 mg 1 2589 +5°C+/-3°C A1A 79 € Y0001561 Abacavir sulfate CRS 1 20 mg 1 2589 +5°C+/-3°C A1A 79 € Y0002199 Acamprosate calcium CRS 1 80 mg 1 See leaflet 1585 +5°C+/-3°C A1A 79 € Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 This reference standard was officially withdrawn from monograph 1585 L 79 € 01/2017:1585 on 01/01/2021 and replaced by Y0002199 Acamprosate calcium. The reference will however remain available for sale for a further 6 months (subject to stock availability), i.e. until 01/07/2021. The reference will remain visible in the catalogue until 01/01/2022. ; Batch 1 is valid until 1 January 2022 Y0000116 Acamprosate impurity A CRS 2 110 mg 1 3-aminopropane-1-sulfonic acid (homotaurine) 1585 +5°C+/-3°C A1A 79 € Y0000500 Acarbose CRS 3 100 mg 1 See leaflet 2089 +5°C+/-3°C A1A 79 € Y0000354 Acarbose for identification CRS 1 10 mg 1 2089 +5°C+/-3°C A1A 79 € Y0000427 Acarbose for peak identification CRS 4 20 mg 1 2089 +5°C+/-3°C A1A 79 € A0040000 Acebutolol hydrochloride CRS 1 50 mg 1 0871 +5°C+/-3°C A1A 79 € Y0000359 Acebutolol impurity B CRS 2 10 mg 1 N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] 0871 +5°C+/-3°C A1A 79 € propoxy]phenyl]acetamide (diacetolol) Y0000127 Acebutolol impurity C CRS 2 20 mg 1 See Leaflet; N-(3-acetyl-4-hydroxyphenyl)butanamide ; Batch 1 is 0871 +5°C+/-3°C A1A 79 € valid until 31 October 2021 Y0000128 Acebutolol impurity I CRS 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2- 0871 +5°C+/-3°C A1A 79 € hydroxypropoxy]phenyl]butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 L 79 € Y0000085 Aceclofenac impurity F CRS 4 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate 1281 +5°C+/-3°C A1A 79 € (benzyl ester of aceclofenac) Y0000086 Aceclofenac impurity H CRS 2 10 mg 1 [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl] 1281 +5°C+/-3°C A1A 79 € oxy]acetyl]oxy]acetic acid (diacetic aceclofenac) Y0001094 Aceclofenac for peak identification CRS 2 10 mg 1 1281 +5°C+/-3°C A1A 79 € Y0001915 Aceclofenac impurity I CRS 1 15 mg 1 1281 +5°C+/-3°C A1A 79 € Y0000810 Acemetacin CRS 1 100 mg 1 1686 +5°C+/-3°C A1A 79 € Y0000811 Acemetacin impurity A CRS 1 10 mg 1 4-chlorobenzoic acid 1686 +5°C+/-3°C A1A 79 € Y0000842 Acemetacin impurity mixture CRS 1 0.06 mg 1 1686 +5°C+/-3°C A1A 79 € A0070000 Acesulfame potassium CRS 2 50 mg 1 1282 +5°C+/-3°C A1A 79 € A0070020 Acesulfame potassium impurity B CRS 5 15 mg 1 see leaflet; 5-chloro-6-methyl-1,2,3-oxathiazin-4(3§)-one 2,2- 1282 +5°C+/-3°C A1A 79 € dioxide ; Batch 4 is valid until 31 October 2020 A0100000 Acetazolamide CRS 1 100 mg 1 0454 +5°C+/-3°C A1A 79 € Y0001084 Acetazolamide for system suitability CRS 3 0.007 mg 1 Batch 2 is valid until 31 March 2021 0454 +5°C+/-3°C A1A 79 € Y0000002 Acetylcholine chloride CRS 2 50 mg 1 1485,1971 -20°C C1A 79 € +/-5°C For extra charges, please see terms and conditions. © Council of Europe, all rights reserved 2021 1 DGD : Dangerous Goods Declaration. List of European Pharmacopoeia Reference Standards Effective from 2021/9/29 Order Reference Standard Batch Quantity Sale Information Monograph Storage Shipping Shipment Price Code n° per vial Unit group with DGD A0150000 Acetylcysteine CRS 4 50 mg 1 Batch 3 is valid until 31 January 2021 0967 +5°C+/-3°C A1A 79 € A0152000 Acetylcysteine impurity C CRS 12 10 mg 1 (2R,2'R)-3,3'-disulfanediylbis[2-(acetylamino)propanoic acid] 0967 +5°C+/-3°C A1A 79 € (N,N'-diacetyl-L-cystine) ; Batch 11 is valid until 31 July 2021 A0153000 Acetylcysteine impurity D CRS 7 10 mg 1 (2R)-2-(acetylamino)-3-(acetylsulfanyl)propanoic acid (N,S- 0967 +5°C+/-3°C A1A 79 € diacetyl-L-cysteine) Y0000565 ß-Acetyldigoxin CRS 2 50 mg 1 See leaflet C÷–HÿÿOŒ— 2168 +5°C+/-3°C A1A 79 € Y0000642 ß-acetyldigoxin for peak identification CRS 1 10 mg 1 2168 +5°C+/-3°C A1A 79 € A0200000 Acetylsalicylic acid CRS 5 10 mg 1 0309 +5°C+/-3°C A1A 79 € Y0001460 Acetylsalicylic acid for peak identification CRS 5 10.3 mg 1 0309 +5°C+/-3°C A1A 79 € Y0001462 Acetylsulfadiazine CRS 2 0.002 mg 1 0294 +5°C+/-3°C A1A 79 € A0208000 N-Acetyltryptophan CRS 3 125 mg 1 Batch 2 is valid until 30 September 2020 1383 +5°C+/-3°C A1A 79 € A0202000 N-Acetyltyrosine CRS 1 200 mg 1 1384 +5°C+/-3°C A1A 79 € Y0000693 Acholeplasma laidlawii BRP 1 1 ml 1 20607 -80°C D1A 120 € +/-10°C Y0002053 Achyranthes bidentata root dry extract for 1 10 mg 1 2999 -20°C C1a 79 € system suitability HRS +/-5°C A0220000 Aciclovir CRS 3 75 mg 1 0968 +5°C+/-3°C A1A 79 € Y0001954 N-acyl-phosphatidylethanolamine from Soya 1 40 mg 1 2316 -20°C C1a 79 € bean CRS +/-5°C New Y0002242 Aciclovir for impurity C identification CRS 2 0.3 mg 1 Batch 1 is valid until 31 December 2021 0968 +5°C+/-3°C A1A 79 € Y0002244 Aciclovir for impurity G identification CRS 1 0.004 mg 1 0968 +5°C+/-3°C A1A 79 € Y0001271 Aciclovir for peak identification 1 CRS 6 0.3 mg 1 This reference standard was officially withdrawn from monograph 0968 +5°C+/-3°C A1A 79 € 01/2014:0968 on 01/04/2021 and replaced by Aciclovir for impurity C identification Y0002242. The reference will however remain available for sale for a further 6 months (subject to stock availability), i.e. until 01/10/2021. The reference will remain visible in the catalogue until 01/04/2022. ; Batch 6 is valid until 2 April 2022 Y0001269 Aciclovir for peak identification 2 CRS 6 0.004 mg 1 This reference standard was officially withdrawn from monograph 0968 +5°C+/-3°C A1A 79 € 01/2014:0968 on 01/04/2021 and replaced by Aciclovir for impurity G identification Y0002244. The reference will however remain available for sale for a further 6 months (subject to stock availability), i.e. until 01/10/2021. The reference will remain visible in the catalogue until 01/04/2022. ; Batch 5 is valid until 31 January 2021 Batch 6 is valid until 2 April 2022 For extra charges, please see terms and conditions. © Council of Europe, all rights reserved 2021 2 DGD : Dangerous Goods Declaration. List of European Pharmacopoeia Reference Standards Effective from 2021/9/29 Order Reference Standard Batch Quantity Sale Information Monograph Storage Shipping Shipment Price Code n° per vial Unit group with DGD Y0001264 Aciclovir for system suitability CRS 2 20 mg 1 This reference standard was officially withdrawn from monograph 0968 +5°C+/-3°C A1A 79 € 01/2014:0968 on 01/04/2021 and replaced by Aciclovir for system suitability A Y0002245. The reference will however remain available for sale for a further 6 months (subject to stock availability), i.e. until 01/10/2021. The reference will remain visible in the catalogue until 01/04/2022. ; Batch 1 is valid until 30 September 2021 Batch 2 is valid until 1 April 2022 Y0002245 Aciclovir for system suitability A CRS 1 20 mg 1 0968 +5°C+/-3°C A1A 79 € A0225000 Acitretin CRS 3 100 mg 1 See leaflet CœŒHœÿO– 1385 +5°C+/-3°C B1A 79 € Y0001987 Acitretin for impurity A identification CRS 1 5 mg 1 1385 +5°C+/-3°C B1a 79 € Y0001464 Actaea racemosa dry extract for system 1 1200 mg 1 2069 -20°C C1A 79 € suitability HRS +/-5°C Y0001543 Actaea racemosa for assay CRS 1 300 mg 1 See leaflet C÷œHÿ—NOŒÿ; Monoammonium glycyrrhizate 2069 +5°C+/-3°C A1A 79 € Y0001463 Actaea racemosa HRS 1 1200 mg 1 2069 +5°C+/-3°C A1A 79 € Y0001121 Adapalene CRS 2 100 mg 1 See leaflet Cœ‡Hœ‡O– 2445 +5°C+/-3°C A1A 79 € Y0001120 Adapalene impurity C CRS 4 10 mg 1 1-(2-methoxyphenyl)tricyclo[3.3.1.1]decane 2445 +5°C+/-3°C A1A 79 € Y0001119 Adapalene for peak identification CRS 2 2.02 mg 1 2445 +5°C+/-3°C A1A 79 € A0230000 Adenine CRS 3 50 mg 1 0800 +5°C+/-3°C A1A 79 € A0230200 Adenosine CRS 1 50 mg 1 1486 +5°C+/-3°C A1A 79 € Y0000110 Adipic acid CRS 1 50 mg 1 1586 +5°C+/-3°C A1A 79 € Y0000882 Adrenaline CRS 1 5 mg 1 Synonym (adrenaline): Epinephrine 2303 +5°C+/-3°C A1A 79 € Y0002246 Adrenaline impurity F CRS 1 0.008 mg 1 Synonym (adrenaline): Epinephrine 2303 +5°C+/-3°C A1A 79 € Y0000740 Adrenaline impurity mixture CRS 4 0.005 mg 1 Synonym (adrenaline): Epinephrine 0254,2303 +5°C+/-3°C A1A 79 € A0300000 Adrenaline tartrate CRS 6 100 mg 1 Synonym (adrenaline): Epinephrine 0254 +5°C+/-3°C A1A 79 € Y0000707 Adrenaline tartrate with impurity A CRS 1 15 mg 1 Synonym (adrenaline): Epinephrine 0254 +5°C+/-3°C A1A 79 € Y0000883 Adrenaline with impurity F CRS 2 0.008 mg 1 Synonym (adrenaline): Epinephrine 2303 +5°C+/-3°C A1A 79 € This reference standard was officially withdrawn from monograph 07/2008:2303 on 01/01/2021.
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  • Flonase Sensimist Allergy Relief (Fluticasone Furoate)

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    Flonase® Sensimist™ Allergy Relief (fluticasone furoate) – Rx-to-OTC Approval • On February 8, 2017, GlaxoSmithKline Consumer Healthcare announced the launch of Flonase Sensimist Allergy Relief (fluticasone furoate) nasal spray, as an over the counter (OTC) treatment to temporarily relieve symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; and itchy, watery eyes (in ages 12 years and older). — Flonase Sensimist Allergy Relief contains 27.5 mcg/spray of fluticasone furoate. — Flonase Sensimist Allergy Relief should not be used in children less than 2 years of age. • Previously, fluticasone furoate was only available by prescription as Veramyst®. Veramyst is no longer commercially available. • Fluticasone is also available OTC as brand (Flonase® Allergy Relief, Children’s Flonase® Allergy Relief) and generic products containing 50 mcg/spray of fluticasone propionate. — These products share the same indications as Flonase Sensimist Allergy Relief, but are not intended for children under 4 years of age. • Prescription fluticasone propionate nasal spray (50 mcg/spray) is available generically and indicated for the management of the nasal symptoms of perennial non-allergic rhinitis in adult and pediatric patients aged 4 years and older. • Warnings for Flonase Sensimist Allergy Relief state the following: — Do not use: in children under 2 years of age, to treat asthma, if there is an injury or surgery to the nose that is not fully healed, or if an allergic reaction to Flonase Sensimist Allergy Relief or any of its ingredients has occurred. — Ask a doctor prior to use if the patient has or had glaucoma or cataracts.
  • Difference Between Patient-Reported Side Effects of Ciclesonide Versus fluticasone Propionate

    Difference Between Patient-Reported Side Effects of Ciclesonide Versus fluticasone Propionate

    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector Respiratory Medicine (2010) 104, 1825e1833 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/rmed Difference between patient-reported side effects of ciclesonide versus fluticasone propionate Thys van der Molen a, Juliet M. Foster a,b, Manfred Caeser c,e, Thomas Mu¨ller c, Dirkje S. Postma d,* a Department of General Practice, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands b Woolcock Institute of Medical Research, 431 Glebe Point Rd, Glebe NSW 2037, Sydney, Australia c Nycomed GmbH, Byk-Gulden-Straße 2, 78467 Konstanz, Konstanz, Germany d Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands Received 18 January 2010; accepted 26 May 2010 Available online 2 July 2010 KEYWORDS Summary Adverse events; Rationale: Patient-reported outcomes provide new insights into the dynamics of asthma Inhaled corticosteroid management. Further to asthma control and quality of life, self-reported side effects of treat- questionnaire; ment can be assessed with the validated Inhaled Corticosteroid Questionnaire (ICQ). ICQ; Objectives: To compare patient-reported side effects between the inhaled corticosteroids Patient-reported ciclesonide and fluticasone propionate. outcomes Methods: Patients with moderate or moderate-to-severe asthma, pre-treated with a constant dose and type of medication, were randomized in three separate studies: 1) once daily cicle- sonide 320 mg(n Z 234) or twice daily fluticasone propionate 200 mg(n Z 240); 2) twice daily ciclesonide 320 mg(n Z 255) or twice daily fluticasone propionate 375 mg(n Z 273); and 3) twice daily ciclesonide 320 mg(n Z 259) or twice daily fluticasone propionate 500 mg (n Z 244).
  • Journal of Pharmaceutical and Biomedical Analysis Stability Of

    Journal of Pharmaceutical and Biomedical Analysis Stability Of

    Journal of Pharmaceutical and Biomedical Analysis 49 (2009) 519–524 Contents lists available at ScienceDirect Journal of Pharmaceutical and Biomedical Analysis journal homepage: www.elsevier.com/locate/jpba Short communication Stability of selected chlorinated thiazide diuretics K. Deventer a,∗, G. Baele b, P. Van Eenoo a, O.J. Pozo a, F.T. Delbeke a a DoCoLab, UGent, Department of Clinical Chemistry, Microbiology and Immunology, Technologiepark 30, B-9052 Zwijnaarde, Belgium b Department of Applied Mathematics and Computer Science, Krijgslaan 281, S9, B-9000 Gent, Belgium article info abstract Article history: In sports, diuretics are used for two main reasons: to flush previously taken prohibited substances with Received 6 August 2008 forced diuresis and in sports where weight classes are involved to achieve acute weight loss. A com- Received in revised form 5 November 2008 mon property observed for thiazides is hydrolysis in aqueous media resulting in the formation of the Accepted 6 November 2008 degradation product aminobenzenedisulphonamide. This degradation product can be observed for sev- Available online 13 November 2008 eral thiazides. Because there is limited information regarding the effect of pH, temperature and light on the stability of thiazides, these parameters were investigated for chlorothiaizide, hydrochlorothiazide Keywords: and altizide. For all three compounds the degradation product could be detected after incubation at pH Doping ◦ Urine 9.5 for 48 h at 60 C. At lower pH and temperature the degradation product could not be detected for all Diuretics compounds. When samples were exposed to UV-light altizide and hydrochlorothiazide were photode- Thiazides graded to chlorothiazide. When the degradation rate between the different compounds was compared Sports for a given temperature and pH, altizide is the most unstable compound.