Información adicional sobre el Sofosbuvir Impurity 36
Fármaco de origen
Sofosbuvir
Nombre IUPAC
Sofosbuvir Impurity 36
Sinónimos
N/A
Descripción
Sofosbuvir Impureza 36 es una impureza relacionada identificada en el perfil de calidad del API de sofosbuvir | potencialmente derivada de rutas sintéticas secundarias o de degradación durante procesos de fabricación y almacenamiento. Su caracterización exige técnicas analíticas avanzadas como HPLC con detección UV | LC-MS y RMN para confirmar estructura y niveles cuantitativos. La presencia de esta impureza puede afectar pureza | rendimiento y estabilidad del producto final | por lo que requiere estrategia de control mediante límites especificados | estudios de degradación forzada y | si procede | calificación toxicológica conforme a guías regulatorias. El monitoreo continuo garantiza cumplimiento de especificaciones y seguridad del lote.
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