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Updated: Aug 15, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s
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Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals

Stephen Horne1, Matthew D Vera2, Laxma R Nagavelli2

  • 1Health Canada, Ottawa, Ontario, Canada K1A 0K9.

Journal of Pharmaceutical Sciences
|January 4, 2023
PubMed

Keywords:
ImpuritiesMutagenicN-nitrosaminesNitrosationPharmaceutical qualityRegulatory co-operationRegulatory scienceRisk factorsRisk mitigationRoot causes

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