Formation of Dialkyl-<i>N</i>-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation-Reference-Cited by-同舟云学术

Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation

Published:2023-02-08 Issue:10 Volume:27 Page:1759-1766
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Ashworth Ian W.¹^ORCID,Dey Debasis²,Dirat Olivier³^ORCID,McDaid Paul⁴,Lee Daniel⁵,Moser Justin⁶,Nanda Kausik K.⁷

Affiliation:

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

2. Pfizer Healthcare India Private Limited, Chennai 602117, India

3. Global CMC, Pfizer Global Product Development, Sandwich CT13 9NJ, United Kingdom

4. Pfizer Process Development Centre, Global Technology & Engineering, Ringaskiddy, Cork P43 X336, Ireland

5. Analytical Chemistry in Development and Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States

6. Global Pharmaceutical Operations Science & Technology, Merck & Co., Inc., West Point, Pennsylvania 19486, United States

7. Discovery Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania 19846, United States

Funder

AstraZeneca

Pfizer

Merck

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.2c00366

Reference31 articles.

1. Regulatory Highlights

2. Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities

3. 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

4. An Organic Chemist’s Guide to N-Nitrosamines: Their Structure, Reactivity, and Role as Contaminants

5. Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond

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