Informações adicionais sobre o Bromfenac Impurity 41
Fármaco de origem
Bromfenac
Nome IUPAC
2-(3-(4-bromobenzoyl)-2-nitrophenyl)acetic acid
Sinônimos
N/A
Descrição
Bromfenac Impurity 41 é uma impureza identificada no perfil de impurezas do bromfenaco | relevante para controle e investigação analítica. Caracteriza-se por presença em traços detectáveis por HPLC e LC-MS | exigindo identificação estrutural | determinação de massa e avaliação de estabilidade sob fotodegradação e hidrólise. O monitoramento inclui desenvolvimento de método seletivo com limites de detecção e quantificação robustos | validação conforme ICH Q3A/Q3B e estabelecimento de limites aceitáveis baseados em avaliação toxicológica. Isolamento e caracterização por NMR e MS permitem definir vias de formação e otimizar rotas sintéticas para minimizar sua geração e garantir conformidade regulatória.
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![1H,1'H-[5,5'-biindole]-7,7'-diylbis((4-bromophenyl)methanone)](https://veeprho.com/wp-content/uploads/2023/05/1H-1-H-5-5-biindole-7-7-diylbis-4-bromophenyl-methanone.png "1H,1'H-[5,5'-biindole]-7,7'-diylbis((4-bromophenyl)methanone)")
