Monitoring and Control of Genotoxic Impurity Acetamide in the Synthesis of Zaurategrast Sulfate

Author:

Schülé Arnaud1,Ates Célal1,Palacio Magali1,Stofferis Jimmy1,Delatinne Jean-Pierre1,Martin Bruno1,Lloyd Steven1

Affiliation:

1. UCB Pharma, Chemical Process Development & Industrialisation and Analytical Development & Industrialisation, Chemin du Foriest, 1420 Braine l’Alleud, Belgium, and UCB Pharma, Pharmaceutical Sciences, Granta Park, Great Abington, Cambridge CB1 6GS, United Kingdom

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference34 articles.

1. Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

2. Mechanism and Processing Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation

3. Controlling the Genotoxins Ethyl Chloride and Methyl Chloride Formed During the Preparation of Amine Hydrochloride Salts from Solutions of Ethanol and Methanol

4. Guidelines on the Limits of Genotoxic Impurities.CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006;European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP):London,June 28, 2006.

5. Questions & Answers on the CHMP Guideline on the Limits of Genotoxic Impurities.EMA/CHMP/SWP/431994/2007,revision 2;European Medicines Agency (EMEA), CHMP SAFETY WORKING PARTY (SWP):London,December 2009.

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