Nitrosamines

N-nitrosamines testing services

At QACS we offer GMP certified N-nitrosamine testing to ensure pharmaceutical quality. We test Final products, Raw materials, API’s & Waters. Equipped with substantial experience in the detection of Nitrosamine impurities  we test Sartan molecules, Pioglitazone, Ranitidine, Esomeprazole, Metformin and other drug medicines. We follow EDQM & FDA methodologies and evaluate the following Nitrosamine impurities:

  • NDMA: N-nitrosodimethylamine
  • NDEA:  N-nitrosodiethylamin
  • NMBA: N-nitroso-N-methylamino butyric acid
  • DIPNA: N-nitrosodiisopropylamine
  • EIPNA: N-nitrosoethylisopylamine
  • NDBA: N-nitrosodibutylamine

Drug production can be endangered by mutagenic nitrosamine properties deriving from Nitrosamine cross-contaminationNitrosamine migration and product degradation. At QACS we test raw materials, recovered materials, packaging materials, API’s, final products. We also tests cross-contaminated samples.

We use suitable analytical equipment for Nitrosamine impurity testing.  Our methodology is GMP compliant and in accordance with EDQM and FDA:

  • 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

Strict EMA (European Medicines Agency) temporary N-nitrosamines limits oblige sartan manufacturers and drug producers to review their manufacturing process according to present LOD Limit Of Detection.  While working towards the goal of non-quantifiable N-nitrosamine impurities, interim levels of NDMA and NDEA have been set in place according to th emaximum daily intake 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 the absence, in quantifiable levels of these impurities.

To assist companies during and after the 2-year transition period, QACS laboratory has invested heavily in state-of-the-art equipment to allow the detection of said impurities down to the LOD that will be enforced after the transition period (0.03ppm).

 

QACS ensures safety and quality in pharmaceutical products with N-nitrosamine detection. For more information for Nitrosamines testing contact us here at info@qacs.gr or give us a call at + (30) 210 29 34745.

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