La impureza 16 de capecitabina es un residuo de síntesis identificado por su perfil cromatográfico y espectrométrico; su presencia puede comprometer el cumplimiento de especificaciones de calidad y estabilidad del principio activo. Caracterizada por determinación por HPLC y confirmación por LC-MS | requiere métodos analíticos validados para su cuantificación y límites de aceptación basados en guías ICH sobre impurezas. Estudios de degradación acelerada permiten evaluar su formación por hidrólisis o oxidación. El control robusto del proceso y la implementación de criterios de retirada garantizan la minimización de esta impureza en el lote final.
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