Rivaroxaban Diol (CAS 1160170-00-2) es una impureza derivada del proceso de síntesis de rivaroxaban que aparece como un compuesto diol polar formado por reacciones secundarias durante etapas de reducción o hidrólisis y por la presencia de subproductos en materias primas o reactivos. Su detección y cuantificación se realizan típicamente por HPLC con detección UV complementada por LC-MS/MS para confirmación estructural. Desde la perspectiva regulatoría se controla bajo límites de impurezas establecidas en ICH Q3A | y su reducción se aborda mediante optimización de proceso | estrategias de purificación cromatográfica y métodos analíticos validados para asegurar cumplimiento de criterios de calidad y seguridad.
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