Fenilefrina Impureza 31 (mezcla de diastereómeros) | CAS 830346-80-0 | constituye una impureza estereoquímica relevante en el control de calidad de principios activos relacionados con fenilefrina. Presenta variación en la composición diastereomérica que puede alterar parámetros cromatográficos y farmacocinéticos. Su identificación y cuantificación exigen técnicas como HPLC analítica y quiral | espectrometría de masas de alta resolución y RMN para asignación de configuraciones relativas. Responsable de picos coeluyentes y posibles desviaciones en estabilidad | sirve como estándar para validar métodos | definir límites de aceptación y estudiar vías de degradación térmica y por humedad | aportando información crítica para el perfil de impurezas y cumplimiento regulatorio.
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