Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Title
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
Authors
Keywords
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Journal
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 27, Issue 10, Pages 1736-1750
Publisher
American Chemical Society (ACS)
Online
2023-07-21
DOI
10.1021/acs.oprd.3c00153

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