Potential for the Formation of N-Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water-Reference-Cited by-同舟云学术

Potential for the Formation of N-Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

Published:2020-08-03 Issue:9 Volume:24 Page:1629-1646
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Ashworth Ian W.¹^ORCID,Dirat Olivier²,Teasdale Andrew¹,Whiting Matthew³

Affiliation:

1. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

2. Pfizer R&D UK Limited, Discovery Park, Ramsgate Road, Sandwich CT13 9NJ, United Kingdom

3. Chemical Development, GlaxoSmithKline, Gunnels Wood Road, Stevenage SG1 2NY, United Kingdom

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.0c00224

Reference101 articles.

1. Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

2. The contamination of valsartan and other sartans, part 1: New findings

3. The contamination of valsartan and other sartans, Part 2: Untargeted screening reveals contamination with amides additionally to known nitrosamine impurities

4. Regulatory Highlights

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