Articles Accepted

Nitrosamine impurities, classified as Human carcinogens, have been detected in pharmaceutical drugs over the past few years. They are distinguished by the Presence of Nitroso functional group and may develop under numerous conditions including manufacturing and Shelf life. This review provides the comprehensive overview of nitrosamines, comprise Risk factors, Nitrosation pathway, Root causes, Acceptable Intake limits. Metabolic activation of nitrosamines is primarily mediated by membrane protein Cytochrome P450 2E1. In addition, this review presents mitigation strategies aimed at addressing and controlling the nitrosamine impurity formation.