Overcoming the challenges of nitrosamine impurities in drugs

What pharmaceutical QA/QC laboratories need to know: Advanced GC-MS capabilities for cGMP nitrosamine testing

contributed by Thermo Fisher Scientific | 03/23/2021

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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