N-Nitrosamine testing services

At QACS Labs we conduct pharmaceutical nitrosamine impurity testing on a large range of pharmaceutical products in line with the published EMA and FDA guidelines.

Nitrosamines are a group of organic compounds, many of which have been classified as probable human carcinogens. QACS Labs has been supporting clients with analytical testing services for nitrosamines since the first reported cases of contamination in 2018. QACS provides Method Development and Method Validations for new analytical methods or Method Transfers for Routine Testing according to existing validated methods for raw materials and final products.

Nitrosamine impurity testing is performed in our sophisticated GMP certified laboratory with state-of-the-art equipment: GC-MS/MS (DI, HS or SPME), UPLC-MS/MS and UPLC-HRAM-MS/MS. To date QACS Labs have successfully implemented methods for the analysis of more than 50 different nitrosamines for confirmatory testing or routine analysis.