Nitrosamines in Drug Substance and Drug Product-A Regulatory Challenge

Abstract

Nitrosamine is the class of synthetic compound which is a potent genotoxic agent and considered as probable plausible human cancer-causing agents by the International Agency for Research on Cancer (IARC).N nitroso mixes are known as the potent carcinogenic and a global worry according to the various authorities and also from ICH M7, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Before June 2018, the presence of nitrosamine in the drug substance and also product was not known, however in June 2018, USFDA identified the presence of Nitrosamine impurities in one of the API producers of valsartan which is recognized as NDMA (N-Nitroso dimethylamine). Valsartan is a medication which is utilized for the treatment of hypertension, cardiovascular breakdown and diabetic kidney damage. From that point forward, FDA has discovered that different kinds of nitrosamine mixes, e.g., N-Nitrosodiethylamine (NDEA), are available at unsuitable levels in APIs from various API makers of valsartan and different medications in the ARB class. (Angiotensin receptor blocker). Then the Regulatory Authorities has stepped forward for educating the health care professional, manufacturers and also public about the adverse effect(carcinogenic)of the NDMA and NDEA consumption.