US FDA: Carcinogenic Potency Categorization Approach for Nitrosamine Impurities

In January 2025, the US FDA has published in the newsroom of the CDER website the article titled “Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach”.

The article recaps the historical context of the development of the Carcinogenic Potency Categorization Approach (CPCA) methodology, that uses the chemical structure of a nitrosamine impurity to recommend acceptable intake (AI) limits, assigning them to one of five predicted potency categories reflecting carcinogenic risk, and provides an analysis of the the number and distribution of α-hydrogens combined with other activating and deactivating features of nitrosamines.

The complete article can be checked in the newsroom of CDER’s website.

SOURCES:

Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach | FDA