Do Carboxylic/Sulfonic Acid Halides Really Present a Mutagenic and Carcinogenic Risk as Impurities in Final Drug Products?
Author:
Affiliation:
1. Sanofi-Aventis Deutschland GmbH, R&D DSAR/Preclinical Safety FF, Industriepark Hoechst, Building H831, D-65926 Frankfurt, Germany
2. GlaxoSmithKline Pre-Clinical Development, Park Road, Ware, Hertfordshire SG12 0DP, U.K.
Publisher
American Chemical Society (ACS)
Subject
Organic Chemistry,Physical and Theoretical Chemistry
Link
https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.5b00106
Reference52 articles.
1. The Reactions of Aliphatic Acid Chlorides.
2. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control
3. OECD Guideline for Testing of Chemicals 471: Bacterial Reverse Mutation Test. Adopted July 21, 1997, 1/11.
4. European Chemicals Agency.http://echa.europa.eu/(accessed Oct 4, 2013).
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