Transcription of 5.11. Nitrosamine Impurities
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5.11. Nitrosamine Impurities
Page 1 of 18 Nitrosamine Impurities In July 2018, nitrosamines became popular when there was recall of angiotensin II receptor blocker (ARB) medicines, known as sartans , due to the presence of an impurity, N-nitrosodimethylamine (NDMA). Valsartan and Losartan are the worst affected and several lots of these products have been recalled globally. N-nitroso compounds are among the structural groups having high potency mutagenic carcinogens in several animal species, and some are classified as probable or possible human carcinogens referred to as the cohort of concern" in ICH M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. So, these Impurities must be controlled at or below the acceptable cancer risk.
dimethylamine [DMA], triethylamine[TEA], N-methylpyrrolidone [NMP]) in the presence of nitrites and acid media. Use of recycled solvents that may contain nitrosamine or their precursors. Use of sanitized water (e.g., chloramines) Insufficient purification.
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