NITROSAMINE IMPURITIES IN MEDICINES: FORMATION, TOXICITY, REGULATIONS, AND CONTROL
NITROSAMINE IMPURITIES IN MEDICINES: FORMATION, TOXICITY, REGULATIONS, AND CONTROL

Summary/Abstract: Nitrosamines are a class of N-nitroso compounds with high thermal and aqueous stability, considered potential carcinogenic and mutagenic substances. They are formed when secondary or tertiary amines react with nitrosating agents (nitrites) under acidic conditions. The detection of N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and other nitrosamines in drugs such as valsartan, ranitidine, and metformin has led to product recalls and strict regulatory measures by the FDA, EMA, and WHO. This paper analyzes the mechanisms of formation, toxicity, sources of contamination, regulatory frameworks, and best practices for risk management, with the aim of ensuring the safety of pharmaceutical products and protecting patient health.

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