Rivaroxaban Impurity 64 (CAS 62457-35-6) es una impureza crítica dentro del perfil de calidad del API Rivaroxaban | caracterizada por una retención diferencial en cromatografía HPLC y un patrón iónico distintivo en LC-MS | complementado por señales diagnósticas en RMN para su elucidación estructural. Esta impureza puede originarse como subproducto de la síntesis o por degradación durante procesos de fabricación y almacenamiento. Su identificación y cuantificación requieren métodos analíticos validados que especifiquen límites de detección y cuantificación | evaluación de estabilidad y criterios de aceptación compatibles con las guías regulatorias ICH sobre impurezas.
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