Nitrosamines (or more formally N-nitrosamines) are organic compounds produced by industrial processes. They are highly potent carcinogens that have been observed as impurities in foods, cosmetics, tobacco products, industrial solvents, and alcoholic beverages for many years.

Nitrosamines are described in the International Conference for Harmonization (ICH) M7(R1) Guideline as Class 1 impurities which are high-potency, mutagenic carcinogens.

Mutagenic impurities in APIs and drug products pose a significant risk to health and safety – even in small quantities—and thus are a major concern for drug makers. Mutagenic impurities can damage DNA, leading to mutations and potentially cancer. Efforts to address and control the presence of trace levels of mutagenic impurities is of special concern to global regulators.

The rise in nitrosamine contamination has prompted global regulatory agencies such as the FDA, EMA, and Health Canada to mandate stringent testing. They have taken steps to address the issue of Nitrosamines impurities in pharmaceuticals.

Detection and quantification of these trace impurities in APIs and drug products can be challenging, necessitating the use of advanced and sensitive tools to meet regulatory requirements.

Nitrosamine impurities can be detected by using state-of-the-art GC/MS and LC/MS/MS instrumentation.

As a leader in contract analytical testing, Shields Pharma Inc. offers fully validated quantitative and qualitative testing methods for a range of Nitrosamine impurities including;

• N-nitrosodimethylamine (NDMA
• N-nitrosomethylethylamine (NMEA)
• N-nitrosopyrrolidine (NPyr)
• N-nitrosodiethylamine (NDEA)
• N-nitrosopiperidine (NPip)
• N-nitrosomorpholine (NMor)
• N-nitrosodi-n-propylamine (NDPA)
• N-nitrosodi-n-butylamine (NDBA)
• N-nitrosodi-n-phenylamine (NDPhA)