Jason Brown*, Adare Pharma Solutions and Kim Huynh-Ba, Pharmalytik, LLC

*Corresponding Author

Nitrosamine impurities have emerged as a significant challenge in the pharmaceutical industry due to their carcinogenic potential and unexpected presence in various drug products. Regulatory authorities including the FDA, EMA, and WHO have responded with strict requirements for identification, risk assessment, and control of these impurities. While guidance continues to evolve, implementation remains complex. Jason Brown and Kim Huynh-Ba present a practical, science-based approach to managing nitrosamine risks throughout the product lifecycle—grounded in ICH Q9 and Q10 principles. (1)

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