Epinastine Impurity 12 (CAS 80012-69-7) | também referida como Epistine Impurity 12 | Epinastine Impurity 14 | 6-cyano-11-hydro-dibenzazepine e 11H-dibenz[b | e]azepine-6-carbonitrile | é uma impureza estrutural associada ao processo sintético da epinastina. Caracteriza-se por centro nitrílico ligado ao anel dibenzazepínico | exibindo perfil cromatográfico e espectral distinto | detectável por HPLC | LC-MS e RMN. A quantificação e identificação dessa impureza são críticas para o desenvolvimento de especificações | estudos de estabilidade e avaliação de risco toxicológico | exigindo padrões analíticos validados e limites de aceitação compatíveis com boas práticas de controle de qualidade.
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