An Inclusive Insight on Nitrosamine: A Reminiscent Carcinogen

Abstract

Nitrosamines, are the potent carcinogenic compounds and are having significant concern in pharmaceutical industry. Specifically, NDMA is a probable human carcinogen. Nitrosamines having the presence of a nitroso and amine group, reacted in the acidic pH and/or under high temperature conditions. Its presence even at trace quantities in medicines concerns due to their carcinogenic and genotoxic nature, confirmed by the animal studies. Hence regulatory authorities implemented stringent guidelines for prohibiting occurrence of these impurities in pharmaceuticals. These impurities may form during API synthesis, can come from the excipients, raw materials, and recovered solvents or it may be the result of degradation pathway. To prevent the occurrence of these impurities it is important to perform vendor qualification, establishing specification for impurities, proper selection of raw materials, reagents, solvents, and packaging material evaluation. This article reviews the history, chemistry, formation, sources, preventive strategies, and acceptable intake limit of nitrosamines.