Betaxolol EP Impurity C (CAS 63659-17-6) | denominado Betaxolol Oxirane Analog [[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane | es una impureza con anillo oxirano que presenta alta reactividad y riesgo de apertura del epóxido | lo que puede generar productos secundarios inestables; su control es crítico en el desarrollo y fabricación del principio activo. La identificación y cuantificación se realizan por HPLC con confirmación por LC‑MS y RMN para caracterizar su perfil químico y de degradación. Se recomienda establecer límites de especificación basados en guías regulatorias | implementar medidas de control en la etapa de síntesis y purificación y evaluar su reactividad frente a nucleófilos y condiciones de almacenamiento.
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