The objective of this standard is to provide a science-based approach for the control of nitrosamine impurities, eliminating or reducing their presence in drug products. The approach described thereby ensures the quality of the product as it relates to safety.
https://online.usppf.com/usppf/document/GUID-C97F817C-A383-4693-8E0C-2F0A0A371977_10101_en-US