News about GMP/cGMP


USP: New General Chapter <1469> on Nitrosamine Impurities

USP: New General Chapter <1469> on Nitrosamine Impurities

As of 2 December 2021, the new general chapter <1469> on nitrosamine impurities has been added to the United States Pharmacopeia (USP). With this, it is intended to support both pharmaceutical manufacturers and authorities in assessing the presence of nitrosamines and implementing appropriate control strategies and analytical procedures. The chapter is aligned with the current FDA guidances.

In addition to the new standard, the USP has developed eight reference standards for various nitrosamine impurities. The standards can be used by manufacturers to detect the presence of nitrosamines in their products. The USP website provides more details and various interesting articles on the topic of nitrosamines.


USP: Nitrosamine impurities