2,3,4,5-Tetrahydro-3-(trifluoroacetyl)-1,5-methano-1H-3-benzazepine-7-amine; Varenicline – In huose impurity
Descripción
El 1-(7-Amino-1 | 2 | 4 | 5-tetrahydro-3H-1 | 5-methanobenzo[d]azepin-3-yl)-2 | 2 | 2-trifluoroethan-1-one (CAS 230615-56-2) es una impureza estructuralmente relacionada con vareniclina que incorpora un núcleo benzazepina sustituido por un grupo trifluoroacetilo y una función amino en posición 7. Desde el punto de vista técnico se considera un subproducto de etapas de acilación o degradación y requiere identificación y cuantificación por HPLC con detección LC-MS complementada por RMN y espectroscopía IR para confirmación estructural. Su control en matriz farmacéutica es crítico para cumplir especificaciones y dirigir estrategias de purificación y desarrollo analítico debido a su polaridad | estabilidad relativa y posibles interferencias en métodos de ensayo.
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