Betaxolol EP Impurity A (CAS 67193-95-7) es una impureza relacionada con betaxolol | conocida también como Betaxolol Related Compound A o 1-(4-ethylphenoxy)-3-(isopropylamino)-2-propanol | que requiere control riguroso en el desarrollo y liberación del API. Se identifica y cuantifica por HPLC con detección UV y por LC-MS | y su estructura se confirma mediante RMN y espectrometría de masas. Esta impureza puede formarse por reacciones secundarias o contaminación de intermediarios durante la síntesis | alterando el perfil de pureza y estabilidad. Los procedimientos de control incluyen métodos analíticos validados | límites de aceptación y estrategias de mitigación según guías regulatorias.
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