Naphazoline Impurity 2 (Di HCl) é o sal di-hidrocloreto associado ao perfil de impurezas de um vasoconstritor imidazolina, formalmente descrito pela fórmula C14H17N3.2HCl e massa molecular de 227.31 2 36.46 g/mol. Na química de processo, essa espécie pode resultar de ciclização incompleta, rearranjo da cadeia lateral ou arraste de formação salina durante a produção de intermediários relacionados à nafazolina. O estado protonado altera retenção cromatográfica e ionização, exigindo caracterização ortogonal por LC-MS/MS, MS de alta resolução e, quando necessário, cromatografia por par iônico ou HILIC. A avaliação regulatória concentra-se na atribuição estrutural, na especificação da impureza e no controle em nível traço, com suporte de RMN e determinação de teor de cloreto.
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