Phenylephrine Related Compound D ;Benzylphenylephrine (R)-Isomer; Phenylephrine Impurity D; Phenylephrine USP Related Compound D
Descripción
Phenylephrine EP Impurity D (CAS 1367567-95-0) | también conocido como Phenylephrine Related Compound D o Benzylphenylephrine (R)-Isomer | es una impureza quiral y relacionada estructuralmente con el principio activo. Se caracteriza por su estereoisomería R y perfiles analíticos específicos como tiempos de retención en HPLC | espectros de masas y señales NMR distintivas que facilitan su identificación y cuantificación en lotes farmacéuticos. Su presencia se controla mediante especificaciones de impurezas y límites de aceptación según monografías EP y guías regulatorias. Estudios de estabilidad y degradación indican rutas formacionales y ayudan a definir estrategias de control de calidad y métodos analíticos validados.
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