FDA’s February 2021 Guidance for the Control of Nitrosamine
Impurities in Human Drugs recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products.”
USP 〈1469〉 details a science- and risk-based approach for the control of nitrosamine impurities to ensure that the potential presence of nitrosamines in drug substances and drug products is identified, assessed, and controlled while providing recommendations for a) the establishment of controls of nitrosamine levels in order to ensure their elimination or reduction; and b) analytical procedure performance characteristics for procedures used to monitor nitrosamine levels.