Rac-trans-4-Hydroxy Glyburide (CAS 23155-04-6) | también denominado 4′-Hydroxyglibenclamide | es una impureza de proceso relevante en la producción de glibenclamida | caracterizada por la hidroxilación en posición 4′ del anillo aromático. Presenta propiedades fisicoquímicas que afectan pureza y perfil de degradación | por lo que su identificación y cuantificación mediante HPLC con detección UV y confirmación por LC-MS/MS son críticas. Debe controlarse en especificaciones mediante límites establecidos | estudios de estabilidad forzados y evaluación de riesgos de seguridad y eficacia. Se recomienda implementar medidas de control de proceso | limpieza y análisis de lote para minimizar su presencia.
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