Comparative Evaluation of Nitrosamine Impurity Control Strategies in USFDA, EMA, and WHO Pharmaceutical Submissions
Nitrosamine impurities are of significant concern to the pharmaceutical industry because of their genotoxic and carcinogenic effects. They are formed during the manufacturing, storage, and/or packaging of APIs and/or drug products owing to the nitrosation reactions of amines with nitrosating reagents. The detection of...