Capecitabine 3-O-BDR Impurity | CAS 1262133-64-1 | es una impureza relacionada que requiere control riguroso en procesos farmacéuticos por su impacto en el perfil de pureza y estabilidad del principio activo. Su detección y cuantificación se realizan comúnmente mediante HPLC y LC-MS para asegurar límites de impurezas y cumplimiento regulatorio. Se caracteriza por su comportamiento en condiciones de degradación forzada y por interferir en métodos analíticos si no se separa adecuadamente. La monitorización sistemática | la validación de métodos analíticos y la evaluación de riesgos durante desarrollo y liberación de lote son esenciales para minimizar su presencia y garantizar calidad del producto.
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