2′-Hydroxy Sofosbuvir es una impureza relacionada con el fármaco Sofosbuvir que se genera por hidroximetilación o hidrólisis en la posición 2′ del nucleósido durante síntesis | desprotección o degradación en almacenamiento. Su presencia altera el perfil de impurezas y puede influir en potencia | estabilidad y perfil farmacocinético | por lo que requiere identificación y cuantificación precisas mediante HPLC-UV | LC-MS/MS y RMN. El control se apoya en estudios de degradación forzada | optimización de pasos sintéticos y fases de purificación | además de establecer límites de especificación y criterios de calificación conforme a ICH Q3A/Q3B para garantizar calidad y seguridad.
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