Elusive Impurities—Evidence versus Hypothesis. Technical and Regulatory Update on Alkyl Sulfonates in Sulfonic Acid Salts

Author:

Snodin David J.1ORCID

Affiliation:

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

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference82 articles.

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

2. National Toxicology Program. Testing Status for Bromobenzene; https://ntp.niehs.nih.gov/testing/status/agents/ts-10060-g.html (accessed June 5, 2018).

3. Chlorobenzene, MAK assessment, pp 104–127, 1995; https://onlinelibrary.wiley.com/doi/pdf/10.1002/3527600418.mb10890e0012 (accessed June 5, 2018).

4. National Council of Educational Research and Training, India. Haloalkanes and haloarenes, Unit 10, pp 281–314, 2015; http://ncert.nic.in/ncerts/l/lech201.pdf (accessed June 4, 2018).

5. Therapeutic Goods Administration, Department of Health, Australia. Guidance 18.2.6. Impurities relating to mesilates, tosilates, (di)isetionate and besilates, 2013; https://www.tga.gov.au/book/182-related-impurities-drug-substances-and-drug-products (accessed April 12, 2019).

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