4-Cloro Bupropiona, também denominada 3,4-dicloro bupropiona ou Bupropion Impurity I, é uma impureza de processo halogenada associada à química do cloridrato de bupropiona. Identificada pelo CAS 1193779-34-8, apresenta fórmula molecular C13H17Cl2NO.HCl e massa molecular de 310,65 g/mol. A espécie indica substituição clorada na cadeia lateral ou no anel aromático, decorrente de intermediários, sobrecloração ou subprodutos específicos da rota sintética. Sua caracterização normalmente exige LC-MS/MS, LC-MS de alta resolução e HPLC ortogonal, com GC-MS como apoio após derivatização. No contexto regulatório, sua avaliação se enquadra em ICH Q3A e ICH Q3B, e, quando aplicável, em ICH M7.
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