EUROLAB We offer GMP certified N-nitrosamine testing to ensure pharmaceutical quality. We test final products, raw materials, APIs and water. Having significant experience in detecting nitrosamine impurities, we test Sartan molecules, Pioglitazone, Ranitidine, Esomeprazole, Metformin and other drugs.
We follow EDQM and FDA methodologies and evaluate the following Nitrosamine impurities:
Pharmaceutical production may be compromised by mutagenic nitrosamine properties resulting from Nitrosamine cross-contamination, Nitrosamine migration, and product degradation. EUROLABAt , we test raw materials, recycled materials, packaging materials, APIs, final products. We also test cross-contaminated samples.
We use appropriate analytical equipment for nitrosamine impurity testing. Our methodology is GMP compliant and EDQM and FDA compliant:
N-Nitrosamine Test Limits
Strict EMA (European Medicines Agency) temporary N-nitrosamines forces manufacturers of sartan and pharmaceuticals to review their manufacturing processes according to the current LOD Detection Limit. While working towards the target of unmeasurable N-nitrosamine impurities, intermediate levels of NDMA and NDEA were established according to the daily maximum emulsion intake of the said Sartan. In the European Union, products containing any level of pollution or both impurities will not be allowed. After the transition period, companies must demonstrate the absence of these impurities at measurable levels.
EUROLAB, with its highly expert team and internationally accredited laboratories, N-nitrosamine Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
