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Overcoming the challenges of nitrosamine impurities in drugs

Why we need to analyze nitrosamine impurities in drugs

Unacceptable levels of nitrosamine impurities were first reported in June 2018 when Valsartan, an angiotensin II receptor blocker containing a tetrazole group, was recalled due to the presence of N-nitrosodimethylamine (NDMA) contamination. Further nitrosamine impurities were subsequently detected in other medications belonging to a group of sartans, including: N-nitrosodiethylamine (NDEA), N-nitrosodiisopropylamine (NDIPA), N-nitrosoethylisopropylamine (NEIPA) and N-nitrosoN-methyl-4-aminobutyric acid (NMBA).1 Nitrosamines are considered a matter of concern as the ICH M7 (R1)2 Guideline classifies them as Class 1 impurities or mutagenic carcinogens and they are categorized as probable carcinogens by the International Agency for Cancer Research (IARC).3

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