Información adicional sobre el Bromfenac Impurity 40
Fármaco de origen
Bromfenac
Nombre IUPAC
2-oxoindolin-7-yl 4-bromobenzoate
Sinónimos
N/A
Descripción
La impureza Bromfenac Impurity 40 es una impureza relacionada con el proceso y la degradación del principio activo Bromfenac | caracterizada por un perfil cromatográfico y espectrométrico distintivo; se detecta y cuantifica mediante HPLC con detección UV y se confirma por LC-MS y RMN cuando se requiere. Su monitoreo es crítico para el control de calidad y la estabilidad | estableciendo límites de aceptación conforme a las directrices regulatorias ICH sobre impurezas. La estrategia de control abarca métodos analíticos validados | estudios de degradación forzada y especificaciones de aceptación para asegurar que no afecte la calidad del lote y facilitar su uso como estándar de referencia analítica.
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![1H,1'H-[5,5'-biindole]-7,7'-diylbis((4-bromophenyl)methanone)](https://veeprho.com/wp-content/uploads/2023/05/1H-1-H-5-5-biindole-7-7-diylbis-4-bromophenyl-methanone.png "1H,1'H-[5,5'-biindole]-7,7'-diylbis((4-bromophenyl)methanone)")
