Bumetanide as a model NDSRI substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets
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D Shakleya, B Asmelash, A Alayoubi, N Abrigo…
Journal of …, 2023
Elsevier
Nitrosamine compounds are classified as potential human carcinogens, the origin of these impurities can be broadly classified in two categories, nitrosamine impurity found in drug products that are not associated with the Active Pharmaceutical Ingredient (API), such as N-nitrosodimethylamine (NDMA) or nitrosamine impurities associated with the API, such as nitrosamine drug substance-related impurities (NDSRIs). The mechanistic pathway for the formation of these two classes of impurities can be different and the approach to mitigate the …
