UFMS Approach to Nitrosamine Analysis
Nitrosamine compounds are classified as probable human carcinogens. Ever since the first FDA notification in June 2018 about levels of these impurities in pharmaceutical API, the number of recalls have been on a rise for angiotensin II receptor blockers and other products like Ranitidine, Metformin etc. The FDA and the European Medicine Agency (EMA) have constantly set and update the guidelines in measuring impurities in pharmaceutical products.
Holistic solution to measurement of nitrosamines needs both GC-MS/MS and LC-MS/MS technologies. Download the handbook to find out more about qualitative and quantitative analysis of these compounds.
Download the applications booklet and find out more about the Ultra-Fast Mass Spectrometry (UFMS) aproach to Nitrosamine Analysis including:
- UFMS Analysis of 15 nitrosamines using LCMS
- Analysis of Nitrosamines in Valsatran
- Analysis of NDEA & NDMA in Metformin
- HRMS quantitation of NDMA in Ranitidine
- UFMS Analysis of 24 nitrosamines using GCMS
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