Empagliflozina Impureza 67 é um subproduto crítico identificado durante o desenvolvimento e controle de qualidade da via sintética da empagliflozina. Quimicamente designada (S)-(5-bromo-2-chlorophenyl)(4-((tetrahydrofuran-3-yl)oxy)phenyl)methanone | esta impureza requer monitorização rigorosa por HPLC com detecção UV e confirmação por espectrometria de massa e RMN para garantir identificação estrutural e limites de quantificação. Estudos de estabilidade avaliam sua formação sob condições de processo e armazenamento | enquanto avaliações toxicológicas e perfil de impurezas genotóxicas suportam justificativas de especificação. Fornecemos dados analíticos e relatórios de caracterização que atendem às expectativas regulatórias para controle de impurezas em ingredientes farmacêuticos ativos.
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