N-nitrosamine testing services
Nitrosamines are organic compounds classified as probable human carcinogens which have been detected in trace levels in certain pharmaceutical products. At QACS Labs we conduct pharmaceutical nitrosamine impurity testing on a large range of pharmaceutical products in line with the latest EMA and FDA guidelines.
Why QACS Nitrosamine Testing
QACS Labs has been supporting clients with analytical testing services for nitrosamines since the first reported cases of contamination in the summer of 2018. We provide Method Development and Method Validation for new analytical methods or Method Transfer for Routine Testing according to existing validated methods for raw materials and final products. QACS Labs are GMP certified.
Nitrosamine impurity testing is performed with UPLC-MS/MS, GC-MS and GC- MS/MS (DI and HS).
QACS Labs can support confirmatory testing for nitrosamines identified in the risk assessment process or routine batch analysis testing of raw materials and finished products where required.