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