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Nitrosamine Detection

HomeQACS - The Challenge Test Laboratory –  Pharma Testing –  Nitrosamine Detection
NN-Nitrosamine testing, Nitrosamine testing, Nitrosamine Impurity Testing, Nitrosamine Impurities, Nitrosamine detection

N-Nitrosamine testing services

Nitrosamines are a group of organic compounds, many of which have been classified as probable human carcinogens. QACS Lab has been supporting clients with N-Nitrosamine testing services since the first reported cases of contamination in 2018. We provide Method Development, Method Validation for new analytical methods, and Method Transfers for routine testing, all according to validated procedures for raw materials and final products.

Nitrosamine impurity testing is conducted on a large range of pharmaceutical products in line with the published EMA and FDA guidelines. N-Nitrosamine detection is performed in our GMP certified laboratory with state-of-the-art equipment: GC-MS/MS (DI, HS or SPME), UPLC-MS/MS and UPLC-HRAM-MS/MS. To date QACS Labs have successfully implemented methods for the analysis of more than 50 different nitrosamines for confirmatory testing or routine analysis.

Enhanced Ames Test

To better evaluate the safety of Pharmaceuticals, QACS Lab provides the Enhanced Ames Test, an in vitro bacterial assay designed to detect mutagenic potential and assess genetic safety, offering a reliable, non-animal approach for regulatory compliance and ingredient evaluation. This critical tool evaluates nitrosamine impurities, which are of particular regulatory concern due to their mutagenic and carcinogenic potential. This extended assay uses additional bacterial strains and adapted protocols to provide a more sensitive and specific detection of nitrosamines compared to the standard Ames Test.

The test is applicable for Chemicals (industrial compounds, raw materials) & Pharmaceuticals (APIs, excipients, and especially nitrosamine impurities)

 

Why Choose QACS Lab for Nitrosamine Testing

  • OECD TG 471 compliant (standard and enhanced Ames Test).

  • Extensive expertise in nitrosamine assessment for pharmaceuticals, including APIs, excipients, and raw materials.

  • GLP-compliant

  • Compliant with REACH, CLP, and ICH M7 guidelines for mutagenic impurities.

  • Advanced analytical capabilities using GC-MS/MS, UPLC-MS/MS, and UPLC-HRAM-MS/MS for routine and confirmatory testing.

  • Proven track record implementing methods for over 50 different nitrosamines.

  • Full-service support: method development, method validation, and method transfer for routine testing.

  • Integrated approach linking nitrosamine analysis with broader safety and genetic toxicology strategies.

  • Fast turnaround times with high accuracy to support timely regulatory submissions.

  • GMP-certified laboratory with modern instrumentation and highly trained analytical scientists.

  • Personalized client support and guidance through complex regulatory requirements.

N-Nitrosamine testing services

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