Nitrosamine Reference Materials

Nitrosamines are carcinogenic impurities: generally categorised as small molecule nitrosamines, which can be found in any drug product, or Nitrosamine Drug Substance Related Impurities (NDSRIs) related to specific APIs.

Discovery of N-Nitrosamines in a drug product can seriously undermine patient trust in a medication, as well as causing product recalls and global drug shortages.

Current nitrosamine regulation includes FDA and EMA guidance on setting acceptable limits for small molecule nitrosamines and NDSRIs through a Carcinogenic Potency Categorization Approach (CPCA).

Our wide range of highly pure small molecule nitrosamine and NDSRI reference materials allow you to ensure that your pharmaceutical testing, research and analysis all comply with FDA and EMA specifications.