Salbutamol EP Impurity H (CAS 132183-64-3) | conocida también como Salbutamol Dideshydroxy Impurity o 4-tert-Butylaminoethyl-2-methylphenol | es una impureza estructural relevante en el control de calidad del salbutamol. Su detección y cuantificación requieren métodos analíticos específicos | típicamente HPLC con detección UV y confirmación por espectrometría de masas. Presenta propiedades fisicoquímicas que pueden influir en estabilidad y pureza del producto final; por ello se establece un límite en especificaciones y se desarrolla un perfil de degradación. La identificación completa | estudios de impureza de proceso y estrategias de mitigación son esenciales para cumplimiento regulatorio y para garantizar la seguridad del producto farmacéutico.
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