La impureza Capecitabine α-Isómero Diacetil representa un derivado estructural formado durante etapas de síntesis o degradación del principio activo | que exige vigilancia en el perfil de impurezas del lote. Su identificación y cuantificación se realizan mediante técnicas cromatográficas y espectrométricas | HPLC con detección UV y LC-MS para confirmación de masa | apoyadas por pruebas de estrés y estudios de degradación forzada. Su control es crítico para establecer especificaciones conforme a ICH Q3A | optimizar procesos de purificación y evaluar estabilidad. La documentación analítica incluye criterios de aceptación | límites de cuantificación y procedimientos de remediación para garantizar la calidad del producto farmacéutico.
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