Impureza N6 | N6-Dipropyl-4 | 5 | 6 | 7-Tetrahydrobenzo[d]thiazole-2 | 6-Diamine Dihydrochloride (CAS 104617-75-6) caracteriza-se como uma espécie salina polar derivada de aminas terciárias | com solubilidade preferencial em meios aquosos ácidos e baixa solubilidade em solventes apolares. No controle analítico aparece como pico de arraste em HPLC e como íon molecular na espectrometria de massa | confirmável por RMN e infravermelho. Sua formação está associada a etapas de alquilação incompleta e protonação excessiva | por isso a quantificação por LC-MS e a remoção por cristalização ou cromatografia iônica são essenciais. Requer qualificação e limitação conforme diretrizes ICH para perfil de impurezas.
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