A impureza Varenicline N-oxide (Mono TFA Salt) apresenta características físico-químicas distintas que exigem monitoramento rigoroso no controle de qualidade de lotes do princípio ativo. Esta entidade oxidada afeta o perfil de impurezas por alterar polaridade | retenção em cromatografia e massa molecular detectável por LC-MS. Procedimentos analíticos validados como HPLC com detecção UV e espectrometria de massas são recomendados para quantificação e identificação. Avaliações de estabilidade forçam condições redutoras e aquecimento para avaliar conversão reversível ou formação de subprodutos. Limites específicos e estratégias de purificação são essenciais para minimizar impacto sobre pureza | segurança e conformidade regulatória.
Referências
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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