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What is Nitrosamine Impurities in Pharmaceuticals about?

This document summarizes an in silico analysis of over 12,000 small molecule drugs and drug impurities to identify structures that could form nitrosamines. The analysis found that 40.4% of APIs and 29.6% of API impurities contain structures that could form nitrosamines. These include complex API-related nitrosamines as well as more potent nitrosamines like NDMA. Many essential drug classes are at risk due to common amine moieties. Determining acceptable intake limits for these nitrosamines is challenging. O

Author

Trần Sơn Hải

Language

EN