Información adicional sobre el 3-chloro-1-(2 | 6-dichlorophenyl)indolin-2-one
Fármaco de origen
Diclofenac
Nombre IUPAC
3-chloro-1-(2, 6-dichlorophenyl)indolin-2-one
Sinónimos
N/A
Descripción
La impureza 3-cloro-1-(2 | 6-diclorofenil)indolin-2-ona presenta relevancia en control de calidad por su origen como subproducto de halogenación durante síntesis de compuestos indolínicos | afectando pureza | perfiles cromatográficos y potenciales propiedades toxicológicas. Su identificación y cuantificación se realizan preferentemente mediante HPLC acoplada a detector UV y confirmación por LC-MS y RMN para determinar posiciones de cloración y posibles isómeros. Se recomienda establecer límites basados en ICH Q3A y monitorizar su formación por control de reactivos | temperatura y tiempo de reacción. Prácticas de purificación | almacenamiento anhidro y documentación de lote minimizan su presencia en el producto final.
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