Impureza 9-Oxo Epinastine (HBr) representa um desvio estrutural relevante na síntese da molécula parental | caracterizada pela oxidação no carbono 9 e pela forma bromidrato | o que pode alterar propriedades físico-químicas e perfil de pureza. A sua identificação e quantificação exigem métodos analíticos validados | incluindo HPLC com detecção UV para triagem | LC-MS para confirmação de massa e RMN para elucidação estrutural. Estudos de estabilidade e testes forçados definem as vias de degradação que originam este óxido | orientando limites de especificação | estratégias de purificação e controles em processo para reduzir risco ao controle de qualidade e à formulacão.
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