Vildagliptin Impurity 37 (HCl Salt) é uma impureza relacionada observada durante a síntese e estabilidade do Vildagliptin sal de cloridrato | exigindo caracterização química e controle rigoroso. Apresenta propriedades analíticas distintas que demandam métodos validados como HPLC com detecção UV | LC-MS para determinação de massa molecular e RMN para confirmação estrutural. Estudos do perfil de impurezas avaliam sua formação | degradabilidade e níveis aceitáveis conforme especificações. Procedimentos de purificação | desenvolvimento de método e ensaios de limite são críticos para monitorar sua presença | garantir especificidade analítica e apoiar documentação regulatória e garantia de qualidade do material farmacêutico.
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