Donepezil N-óxido (CAS 120013-84-5) es una impureza oxidativa del donepezilo generada por la oxidación de la amina terciaria a N-óxido. Su identificación analítica se realiza mediante LC-MS con incremento de masa de +16 Da respecto al compuesto progenitor | cromatografía HPLC con tiempo de retención característico y confirmación por 1H y 13C NMR mostrando desplazamientos en los protones del anillo piperidínico. Se forma bajo estrés oxidativo | exposición a peróxidos o luz y puede afectar estabilidad y potencia si no se controla. Estrategias de control incluyen condiciones de síntesis y almacenamiento reductoras | uso de antioxidantes | purificación por cromatografía y límites en especificaciones según ICH Q3A.
Referencias
Sreelatha, P., et al.
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