N-nitrosamines, characterized by a chemical structure containing a nitroso (-NO) functional group attached to the amine nitrogen, have garnered attention from health authorities due to their classification as probable human carcinogens. This has prompted stringent limitations on their presence in pharmaceuticals, given their mutagenic and carcinogenic effects. Since June 2018, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have actively monitored nitrosamine levels, implementing rules on the maximum permissible levels.
The necessity for compliance with low limits has driven the demand for mass spectrometer-coupled chromatography techniques in the determination of N-nitrosamines. LabSense specializes in both the development of new methods and the provision of validated methodologies, utilizing advanced technologies such as LC-MS/MS, LC-QTOF and precise sample measurements. This commitment ensures strict adherence to regulatory standards, ultimately enhancing the overall safety of pharmaceutical products.
Nitrosamines in Pharmaceuticals
