Impureza asociada a Rivaroxaban (1604530) | CAS 366789-02-8 | identificada como un producto secundario de síntesis y degradación | presenta un perfil cromatográfico distinto y mayor polaridad respecto al principio activo. Su identificación se realiza mediante HPLC con detección UV y confirmación por LC-MS y RMN para asegurar evidencia estructural. Esta impureza puede influir en el perfil de estabilidad y requiere control riguroso en el perfil de impurezas | con límites cuantitativos y estrategia de calificación basada en estudios de exposición y toxicidad. El análisis reproducible y la monitorización durante el desarrollo y liberación de lotes son esenciales para cumplimiento regulatorio y calidad.
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