Approaches and Considerations for the Investigation and Synthesis of <i>N</i>-Nitrosamine Drug Substance-Related Impurities (NDSRIs)-Reference-Cited by-同舟云学术

Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Published:2023-05-30 Issue:10 Volume:27 Page:1784-1791
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Ashworth Ian W.¹^ORCID,Blanazs Alexander¹^ORCID,Byrne Jonathan J.¹^ORCID,Dirat Olivier²^ORCID,Fennell Jared W.³^ORCID,Kuhl Nadine⁴^ORCID,Wells Stuart L.⁵,Whiting Matthew P.⁶

Affiliation:

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

2. Regulatory CMC, Pfizer Global Regulatory Sciences, Sandwich CT13 9NJ, United Kingdom

3. Synthetic Molecule Design & Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, United States

4. Process Research and Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States

5. Clinical Manufacturing and Supply, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

6. Drug Substance Development, GSK, Stevenage SG1 2NY, United Kingdom

Funder

AstraZeneca

Pfizer

GlaxoSmithKline

Eli Lilly and Company

Merck

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00084

Reference39 articles.

1. FDA Announces Voluntary Recall of Several Medicines Containing Valsartan Following Detection of an Impurity. U.S. Food and Drug Administration, July 13, 2018, updated August 7, 2018. https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity (accessed 2022-11-24).

2. FDA Provides Update on Its Ongoing Investigation into ARB Drug Products; Reports on Finding of a New Nitrosamine Impurity in Certain Lots of Losartan and Product Recall. U.S. Food and Drug Administration, March 1, 2019. https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-arb-drug-products-reports-finding-new-nitrosamine (accessed 2022-11-24).

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