Impureza de Apixabán 3 (CAS 2098457-92-0) es un subproducto sintético identificado como componente del perfil de impurezas del apixabán; se caracteriza por análisis HPLC con tiempo de retención definido y confirmación estructural mediante LC-MS y RMN. Su origen se atribuye a reacciones secundarias durante la síntesis o a rutas de degradación bajo condiciones de proceso. La impureza requiere aislamiento | cuantificación y establecimiento de límites en especificaciones conforme a guías ICH | y su control incluye optimización de etapas de purificación | condiciones de reacción y estudios de estabilidad forzados. La documentación analítica y metodologías validadas son esenciales para su gestión en control de calidad.
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