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In this application note, a method for the quantification of mutagenic Nitrosamine drug substance related impurity is described.
A LC/MS/MS based method for the quantitation of ‘N-nitroso Bumetanide impurity’ in Bumetanide API and low dose tablets.
A highly sensitive LC/MS/MS method for the simultaneous determination of eight nitrosamine impurities in metformin drug substance and drug products.