La impureza N-Desmetil Rosuvastatina Disodio Monohidrato es un derivado desmetilado que aparece como impureza relacionada en la síntesis y degradación de rosuvastatina. Su presencia afecta el perfil de impurezas del lote y puede reducir la potencia y modificar el perfil farmacocinético si no se controla. Se recomienda caracterizarla mediante HPLC acoplada a detectores UV y confirmación por LC-MS para determinar retención, espectro y masa exacta. Debe definirse en especificaciones con límites de aceptación basados en toxicología y estudios de estabilidad. Estrategias de control incluyen optimización de pasos sintéticos, condiciones de purificación y estudios forzados de degradación para asegurar cumplimiento regulatorio.
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