(3R, 5R)-7-(2, 3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3, 5-dihydroxyheptanoate, sodium salt (1:1)
Sinónimos
Atorvastatin Related compound C; Fluoro Atorvastatin; Atorvastatin Difluoro Analog (Na Salt)
Descripción
Atorvastatin EP Impurity C (sal sódica) | CAS 1807481-00-0 | es un análogo difluorado relacionado estructuralmente con atorvastatina. Esta impureza relevante en el perfil de calidad farmacéutica requiere monitoreo riguroso por HPLC para cuantificación y por LC-MS y RMN para confirmación estructural. Su presencia | aunque en niveles traza | puede afectar la evaluación analítica y la estabilidad | por lo que se establecen límites de aceptación y métodos de degradación forzada para su identificación. La información técnica y las especificaciones para control de calidad facilitan su gestión durante el desarrollo | la manufactura y la liberación de lotes.
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