Nitrosamines testing, Pharmaceutical Impurities testing, NDMA testing, NDEA testing, NMBA testing, EIPNA, DIPNA, Sartans testing, nitrosamine impurities testing, nitrosamine impurity analysis, nitrosamine detection

N-nitrosamines 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 impurities 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

NDMA: N-nitrosodimethylamine

NDEA:  N-nitrosodiethylamin

NMBA: N-nitroso-N-methylamino butyric acid

DIPNA: N-nitrosodiisopropylamine

EIPNA: N-nitrosoethylisopylamine

NDBA: N-nitrosodibutylamine

Nitrosamine impurity 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.

For Nitrosamine testing services contact us –  info@qacs.gr – 30 210 29 34745