Nitrosamine Reference Materials

Nitrosamines are carcinogenic impurities: generally categorised as either small molecule nitrosamines that can be found in any drug product, or Nitrosamine Drug Substance Related Impurities (NDSRIs) related to specific Active Pharmaceutical Ingredients (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. Both nitrosamine regulation and nitrosamine research have therefore accelerated in recent years - meaning that we now know a great deal more about potential contamination pathways and mitigation strategies for small molecule nitrosamines and NDSRIs. Current regulation also includes FDA and EMA nitrosamine guidance, based on setting acceptable limits through a Carcinogenic Potency Categorization Approach (CPCA).

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