Aceclofenac Impurity 2 | identificada como ácido 3-(1 | 1-dimetiletil)benzenoacético (sinónimo 3-(1 | 1-Dimethylethyl)benzeneacetic acid) | CAS 42288-53-9 | es una impureza estructuralmente relacionada con Aceclofenac que puede formarse durante la síntesis o el almacenamiento. Desde el punto de vista analítico presenta un perfil aromático y una acidez moderada que afectan la cromatografía y la cuantificación por métodos basados en cromatografía líquida y espectrometría de masas | por lo que su identificación y cuantificación son críticas para la evaluación de calidad y cumplimiento regulatorio; su control ayuda a garantizar la pureza farmacéutica y a minimizar riesgos de estabilidad e impurezas relacionadas.
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