Capecitabine Impurity 14 | una mezcla de diastereómeros atribuible a procesos de síntesis o degradación | requiere evaluación detallada en control de calidad farmacéutico. Presenta comportamiento cromatográfico complejo con picos parcialmente separados en HPLC y respuesta en espectrometría de masas consistente con isómeros configuracionales. Su identificación y cuantificación mediante HPLC-UV | LC-MS/MS y RMN es esencial para determinar perfil de impurezas | límites de aceptación y vías de degradación. El seguimiento de esta impureza es crítico para asegurar estabilidad | seguridad y cumplimiento de las guías ICH relativas a impurezas orgánicas. Se recomienda disponer de estándares de referencia y métodos validados para su monitoreo rutinario.
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