1 | 5 | 6 | 7 | 8 | 9-Hexahydro-5 | 9-methanoimidazo[4 | 5-h][3]benzazepine hydrochloride (CAS 230615-10-8) | conocido también como Varenicline Impurity 3 | es una impureza clave que exige monitorización analítica durante la síntesis y formulación del principio activo. Como sal de clorhidrato presenta carácter básico y polar | lo que favorece su extracción y detección por técnicas como HPLC con detección UV | LC-MS y confirmación por RMN. Su presencia puede originarse por rutas de reacción incompletas o degradación intermedia | por lo que el control de proceso | límites de especificación y estudios de estabilidad son críticos para garantizar pureza del API y cumplimiento regulatorio.
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![1,5,6,7,8,9-Hexahydro-5,9-methanoimidazo[4,5-h][3]benzazepine hydrochloride](https://veeprho.com/wp-content/uploads/2022/12/Rivaroxaban-Nitrosamine-Impurity-II-sqr.png "1,5,6,7,8,9-Hexahydro-5,9-methanoimidazo[4,5-h][3]benzazepine hydrochloride")
