Impureza Epinastine EP Impurity B (CAS 1217052-16-8) | também referida como 7-bromo epinastina ou 3-amino-7-bromo-9 | 13b-dihidro-1H-dibenz[c | f]imidazo[1 | 5-a]azepina | é um derivado bromado identificado como impureza relacionada no processo de síntese da epinastina. Caracteriza-se pela presença de um átomo de bromo na posição 7 e pelo núcleo imidazo-azepina | o que altera polaridade e comportamento de ionização. A detecção e quantificação são realizadas por HPLC com detecção UV e LC-MS para confirmação de massa | com 1H/13C NMR para elucidação estrutural. Controle de processo | otimização da bromação e purificação são essenciais para limitar sua formação e garantir conformidade analítica.
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