N-Nitroso Donepezil EP Impurity A ist eine nitrosaminbezogene Verunreinigung, abgeleitet vom piperidylischen tertiären Amin-Gerüst von Donepezil, mit der Summenformel C17H22N2O4 und einer Molekülmasse von 318,4 g/mol. Solche Spezies können durch nitrosative Umwandlung während der Synthese, Lagerung oder bei Kontakt mit nitrosierenden Agenzien entstehen und werden unter ICH M7 aufgrund der Strukturwarnung der N-Nitroso-Funktion als potenziell mutagene Verunreinigungen bewertet. Die Bestimmung erfordert in der Regel hochselektive LC-MS/MS, häufig ergänzt durch hochauflösende LC-MS oder GC-MS nach geeigneter Derivatisierung oder Extraktion, da regulatorisch sehr niedrige Grenzwerte und Matrixeffekte zu berücksichtigen sind.
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