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Sisthema & Chiman in partnership on the front line in Genotoxic impurities Evaluation and Determination

N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), both classified as probable human carcinogens, were not identified as impurities of Sartan APIs and now the same problem was found in Ranitidine HCl drug product. Sodium azide, Zin Chloride in presence of Dimethyl formamide giving quenching with sodium nitrite transformed it in nitrous acid. Nitrous acid fast reacting with secondary amines gives N – Nitrosamines, classified as human carcinogens.