Impureza 5-Cloro Bupropiona (CAS 1346603-00-6) é um subproduto halogenado crítico no perfil de impurezas de síntese da bupropiona | identificado também como 3 | 5-dicloro bupropion ou 1-(3 | 5-dichlorophenyl)-2-[(1 | 1-dimethylethyl)amino]-1-propanone hydrochloride (1:1). Esta impureza apresenta prioridade analítica devido ao potencial impacto na pureza | estabilidade e segurança do lote final. Recomenda-se monitoramento por HPLC com detecção UV e confirmação por LC-MS para limitar níveis dentro das especificações ICH Q3A/Q3B. Avaliação de solubilidade | forma cristalina e perfil de degradação é essencial para definição de limites | métodos de remoção e justificativa toxicológica.
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