Nitrosamine compounds are potent genotoxic agents in several animal species and some are classified as probable or possible human carcinogens by the International Agency for Research on Cancer (IARC). The guidance recommends control of any known mutagenic carcinogen, such as nitroso-compounds, at or below a level such that there would be a negligible human cancer risk associated with the exposure to potentially mutagenic impurities FDA recommended that manufacturers take action to quantify nitrosamine levels in their drugs and to reduce or remove these impurities when above the interim limit. FDA has used the interim limits to guide immediate decision-making for additional evaluation and product recalls while balancing the risks of potential long-term carcinogen exposure with disruption to clinical management of patients.
Figure: Nitrosamine impurities in medicine and food
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