US FDA: Carcinogenic Potency Categorization Approach for Nitrosamine Impurities

In January 2025, the US FDA has published in its newsroom on the CDER website the article called "Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach". It is structured in the following chapters and passages:

• Background
• Materials and Methods
• Results
  A) α-Hydrogen features in the format "n,n" where the lowest number of hydrogens is listed first
  B) Deactivating features
  C) Activating features
• Discussion
• Other resources

The article clearly explains the historical background of developing and establishing the "Carcinogenic Potency Categorization Approach (CPCA)" and provides an overview of deactivating and activating features in a listed order. 

The complete article "Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach" can be checked in the newsroom of CDER's website.