Nitrosamines in pharmaceuticals and cosmetics

Nitrosamines are organic compounds formed by a nitrosating reaction between certain amines and nitrosating agents in acidic conditions. While they are not intentionally added to products, nitrosamines may end up in pharmaceuticals and cosmetics as impurities when manufacturing or storage conditions are conducive to their formation.

As many nitrosamines are highly potent carcinogens, the European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA) require pharmaceutical companies to assess the risk of nitrosamine impurity presence in pharmaceutical products, including Active Pharmaceutical Ingredients (APIs) and finished products.

An updated list of maximum acceptable intake (AI) levels for known nitrosamine impurities to be monitored in Europe can be found in Appendix 1 to EMA's latest guidance document. For US rules, see the FDA's list of recommended AI limits.

We can provide nitrosamine testing for various products and matrices. The displayed price example is for a routine analysis (non-GMP) of one sample including screening of the following nitrosamines:

• NDMA (N-Nitrosodimethylamine)

• NMEA (N-Nitrosomethylethylamine)

• NPYR (N-Nitrosopyrrolidine)

• NDEA (N-Nitrosodiethylamine)

• NPIP (N-Nitrosopiperidine)

• NMOR (N-Nitrosomorpholine)

• NDPA (N-Nitrosodi-n-propylamine)

• NDELA (N-Nitrosodiethanolamine)

• NDIPLA/NBHPA (N-Nitrosodiisopropanolamine)

New samples/products might need a feasibility study before routine testing. Please ask for a quote for the feasibility study and GMP analyses.

We can also offer custom nitrosamine test packages tailored to your needs, especially for large sample volumes. Please ask for a quote for your samples!