Impureza Lurasidone Metabolite 14326 (CAS 2070009-33-3) | também referida como 5?/6?-Hydroxy Lurasidone ou Lurasidone metabolite 14326 | é um produto de hidroximação do núcleo lurasidona que exige monitoramento analítico rigoroso no perfil de impurezas. Caracterizada por modificação hidroxila posicional | esta impureza influencia propriedades cromatográficas e espectrométricas sendo detectável por LC-MS e confirmável por RMN. Para controle de qualidade recomenda-se utilização de padrão de referência | desenvolvimento de métodos HPLC/UPLC validados para quantificação e estudos de estabilidade forçando oxidação e fases de degradação. A identificação precisa e limites de aceitação são críticos para garantir conformidade regulatória e consistência do lote.
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