La impureza Capecitabine α-Isomer es un isómero estereoisomérico del principio activo que puede formarse durante la síntesis o por epimerización en condiciones ácidas o básicas. Presenta propiedades fisicoquímicas y espectrales similares al compuesto principal | lo que complica su separación y cuantificación; por ello se requiere análisis por HPLC quiral | LC-MS y RMN para identificación y perfil de pureza. Su presencia afecta la potencia y perfil farmacocinético | por lo que se establecen límites de aceptación y estrategias de control como optimización de condiciones de síntesis | purificación adicional y estudios de estabilidad forzados. La documentación analítica debe incluir límites de cuantificación y criterios de liberación.
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