Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging Regulatory Perceptions-Reference-Cited by-同舟云学术

Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging Regulatory Perceptions

Published:2015-04-02 Issue:11 Volume:19 Page:1465-1485
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Snodin David¹,Teasdale Andrew²

Affiliation:

1. Xiphora Biopharma Consulting, Bristol, BS6 7BG, U.K.

2. AstraZeneca, Hurdsfield Road, Macclesfield, SK10 2NX, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op500397h

Reference129 articles.

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2. Questions and answers on the ‘Guideline on the limits of genotoxic impurities’;European Medicines Agency:London, 2010; http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002907.pdf.

3. Guidance 18: Impurities in drug substances and drug products. 18.2.6 Impurities relating to mesilates, tosilates, (di)isethionate and besilates;Therapeutic Goods Administration:Symonston, Australia, 2013; http://www.tga.gov.au/industry/pm-argpm-guidance-18-02.htm#.U43RzMIU_PQ.

4. Request to assess the risk of occurrence of contamination with mesilate esters and related compounds in pharmaceuticals, EMEA/44714/2008;European Medicines Agency:London, 2008; http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/11/WC500015375.pdf.

5. Mohan, G.Control of genotoxic impurities and the regulatory impact of this: a case study,AAPS Annual Meeting,Los Angeles, CA, November, 2009; http://mediaserver.aaps.org/meetings/09AM/Slides/11.12.09_Thu/409%20AB/1330/Ganapathy%20Mohan.pdf.

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