Donepezil Impurity 27 (HCl) es una impureza orgánica relacionada con el proceso de síntesis de donepezilo que exige control riguroso en el desarrollo y liberación de materia prima. Presenta propiedades fisicoquímicas que facilitan su identificación por HPLC con detectores UV | confirmación por LC-MS y caracterización estructural mediante RMN. Su presencia puede indicar desviaciones en condiciones de reacción o rutas de degradación y afectar parámetros de seguridad y eficacia si supera los límites especificados. La cuantificación precisa | el establecimiento de límites de aceptación y la optimización de pasos de purificación son medidas críticas para minimizar este contaminante y cumplir requisitos regulatorios.
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