La impureza Deoxy Donepezil (CAS 844694-84-4) | también referida como 4-[(2 | 3-dihidro-5 | 6-dimetoxi-1H-inden-2-il)metil]-1-(fenilmetil)piperidina clorhidrato o Donepezil Deoxy Impurity | es un derivado desoxigenado que surge como subproducto durante la síntesis y la degradación del donepezil. Presenta un perfil analítico distintivo detectable por HPLC uPLC con detectores UV | confirmación por espectrometría de masas y caracterización estructural por RMN. Su presencia puede afectar la pureza farmacéutica y los límites de especificación | por lo que se recomiendan estrategias de control de proceso | pruebas de estabilidad forzada y métodos validados para cuantificación y eliminación en etapas de purificación.
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