La impureza Rivaroxaban Ethylamino Analog (2HCl) es un sal derivada que puede aparecer durante la síntesis o degradación del principio activo Rivaroxaban y representa un riesgo para el perfil de pureza del API. Su caracterización requiere técnicas analíticas robustas como HPLC con detección UV, LC-MS para confirmación de masa, NMR para estructura y HRMS para masa exacta. Es esencial definir límites de especificación, métodos de cuantificación validados y estudios de estabilidad para evaluar su formación bajo condiciones de proceso y almacenamiento. Las estrategias de control incluyen optimización de la etapa sintética, purificación y monitoreo en línea para minimizar su presencia en el lote final.
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