Pharmaceutical companies are coming under increased scrutiny by regulators across the world to accurately identify and quantify trace level nitrosamine impurities in drug substances and products. In this presentation, we will cover a brief introduction of N-Nitrosamines, past experiences and current scenarios. We will provide a summary of genotoxic impurities (GTIs), literature, regulations, and expectations of the regulatory bodies. We will also discuss proactive measures to be taken to minimize the formation of GTIs like nitrosamines.
