1H | 1’H-[5 | 5′-biindole]-7 | 7′-diylbis((4-bromophenyl)methanone) | CAS 2192334-72-6 | é uma impureza observada em lotes de bromfenac | também referida como Bromfenac sodium Impurity 25 | BromfecImpurity62 | Bromfenac Impurity 62. Quimicamente caracterizada por estrutura biindólica com dois grupos benzofenona bromados | esta impureza apresenta massa molecular elevada e baixa solubilidade em meios aquosos | exigindo condições cromatográficas e espectrométricas otimizadas para identificação por HPLC | LC-MS e R-NMR. Sua presença pode impactar perfis de pureza e estabilidade do medicamento e requer investigação de origem | vias de formação e limites analíticos conforme requisitos de controle de qualidade e regulatórios.
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