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Analysis of nitrosamine impurities according to USP General Chapter < 1469 >
Since July 2018, the detection of nitrosamines, classified as probable human carcinogens, such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in the API of valsartan, ranitidine, and metformin has led to the worldwide recall and discontinuation of related products. As a result, demand for nitrosamine analysis is increasing worldwide.
In December 2021, the United States Pharmacopeia (USP) published General Chapter < 1469 > Nitrosamine Impurities, as a general test method to help establish risk assessments and management strategies for nitrosamine impurities.
USP General Chapter < 1469 > has been developed in line with current scientific and regulatory approaches to ensure the appropriate control of nitrosamine impurities in APIs and drug formulation, and is intended to provide a science-based approach for eliminating or reducing their presence in pharmaceuticals.
The analysis methods in USP General Chapter < 1469 > use headspace GC-MS/MS for Procedure 2 and HPLC-MS/MS for Procedure 3. This article introduces the analysis of nitrosamines by headspace GC-MS/MS and LC-MS/MS methods.
Procedure 2: Quantitative Analysis of NDMA, NDEA, NDIPA, and NEIPA by headspace GC-MS/MS
Procedure 3: Quantitative Analysis of NDMA, NDEA, NDIPA, NEIPA, NMBA, and NDBA by HPLC–MS/MS
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