El ácido 4 | 5-dihidroxi-2-(1-hidroxi-2-(metilamino)etil)benzenosulfónico es una impureza polar frecuente en rutas sintéticas que incorporan grupos amino e hidroxilo. Presenta elevada solubilidad acuosa | fuerte capacidad de formación de puentes de hidrógeno y un grupo sulfónico ionizable que dificulta su eliminación por extracción orgánica. Su identificación es óptima mediante HPLC-UV acoplado a LC-MS por el patrón de fragmentación y desplazamientos característicos en RMN protonada y 13C. La impureza muestra susceptibilidad a oxidación y racemización bajo condiciones ácidas o oxidantes. Para control de calidad se recomiendan métodos cromatográficos iónicos y enriquecimiento por SPE | con límites de aceptación definidos por riesgo toxicológico y perfil farmacéutico.
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