N-nitrosamine testing services
Drug production is endangered by N-nitrosamines that occur from cross-contamination, Nitrosamine migration and product degradation as well as their mutagenic properties. QACS Labs conduct pharmaceutical nitrosamine impurity testing to cover product life-cycle stages and test Sartan molecules, Pioglitazone, Ranitidine, Esomeprazole, Metformin and other drug medicines.
QACS GMP compliant methodologies stay in accordance with EDQM & FDA. We test final, recovered, raw, packaging, cross-contaminated materials, API’s & Waters.
N-nitrosamines in question
NMBA: N-nitroso-N-methylamino butyric acid
Nitrosamine impurities testing is performed using UHPLC-APCI-MS/MS analysis according to EDQM suggested CVUA Karlsruhe method.
- GC-MS (Headspace) analysis based on EDQM suggested PALG method / FDA method
- Method Validation for final products
To assist companies, Lab allows for impurities detection to the LOD that will be enforced after the transition period (0.03ppm)
While working towards the goal of non-quantifiable N-nitrosamine impurities, QACS conducts pharmaceutical impurity testing for interim levels of NDMA and NDEA detection in accordance with the daily maximum level of the specific sartan in question.
Products containing either impurity above the limits or both impurities at any level, will not be allowed in the European Union. After the transition period companies have to demonstrate absence, in quantifiable levels of these impurities.