Varenicline N-oxide (Mono TFA Salt) aparece como impureza importante en el perfil de calidad de varenicline | típicamente generada por oxidación del núcleo piridina durante síntesis o almacenamiento. Como sal mono trifluoroacetato se caracteriza por solubilidad y comportamiento cromatográfico distintivos; su identificación y cuantificación se realizan por HPLC-UV acoplado a LC-MS y confirmación estructural por RMN. La presencia puede afectar especificaciones de pureza y estabilidad | por lo que se establece límites de aceptación y pruebas de degradación forzada. Las estrategias de control incluyen optimización de rutas sintéticas | condiciones de purificación y monitoreo rutinario en control de calidad.
Referencias
Ebbert, J., Burke, M. V., & Hays, J. T. (2016). Varenicline for smoking cessation: a narrative review of efficacy, adverse effects, use in at-risk populations, and adherence. Patient Preference and Adherence, 435. https://doi.org/10.2147/ppa.s83469
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