Impureza Aceclofenac Impurity 4 es un perfil de degradación identificado durante estudios de estabilidad del principio activo aceclofenaco. Químicamente se caracteriza por cambios en el grupo funcional que afectan la polaridad y el tiempo de retención en HPLC. Su identificación se confirma mediante cromatografía líquida acoplada a espectrometría de masas y resonancia magnética nuclear | permitiendo determinación de masa exacta y estructura. Presente en niveles traza | su monitoreo es crítico para control de calidad | cumplimiento de especificaciones y seguridad del producto final. Se documentan vías de formación por hidrólisis y oxidación y se recomiendan controles de proceso y purificación para mantener límites regulatorios.
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