Capecitabine Impurity 4 (CAS 1313238-38-8) es una impureza identificada en el perfil de calidad de capecitabina que requiere control analítico riguroso para asegurar la pureza del principio activo. Su identificación por HPLC acoplada a espectrometría de masas permite caracterizar su peso molecular | fragmentación y retención | facilitando la diferencia entre impurezas sintéticas y productos de degradación. Se recomienda desarrollar métodos validados para cuantificación precisa | establecer límites de especificación basados en toxicidad y estabilidad | y monitorizar su formación durante síntesis | purificación y almacenamiento para garantizar cumplimiento regulatorio y consistencia del lote.
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