Información adicional sobre el Pantoprazole Impurity 28
Fármaco de origen
Pantoprazole
Sinónimos
N/A
Descripción
Pantoprazole Impurity 28 es una impureza relacionada con pantoprazol identificada durante el desarrollo y control de calidad que puede originarse por rutas sintéticas incompletas o por degradación bajo condiciones ácido | alcalinas | térmicas u oxidativas. Su caracterización estructural se realiza mediante LC-MS para determinación de masa exacta y espectroscopía de RMN para confirmación de estructura | complementadas con HPLC reversa cuantitativa para perfil de impurezas. Desde la perspectiva regulatoria se controla según umbrales de calificación establecidos por ICH y especificaciones de lote. Las estrategias de mitigación incluyen optimización del proceso | pasos de purificación adicionales y control de condiciones de almacenamiento y pH.
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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
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