Mutagenic impurities in APIs and drug products pose a significant risk to health and
safety—even in small quantities—and thus are a major concern for drug makers.
Mutagenic impurities can damage DNA, leading to mutations and potentially
cancer.
Nitrosamines are formed by chemical reactions that occur during API
manufacturing whether from starting materials, intermediates, reactants, reuse of
solvents and by-products; they can form through degradation products generated
during formulation or storage or from environmental contaminants. Recently,
nitrosamines have been found in sartan drugs, a class of medications used to treat
high blood pressure and heart failure, prompting recalls of angiotensin receptor
blockers (ARBs)—valsartan, losartan, and irbesartan—which were contaminated
with N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), two
carcinogenic impurities. Since then, several other N-nitrosamines have also been
identified and are being investigated by regulators: N-Nitrosodiispropylamine
(NDIPA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodibutylamine (NDBA),
and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Nitrosamines have now also
been identified in ranitidine medications (which are used to treat heartburn and
acid reflux) and metformin, an oral diabetes medication.
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