Informações adicionais sobre o Bromfenac Impurity 25 (DiSodium Salt)
Fármaco de origem
Bromfenac
Nome IUPAC
2-(2-amino-3-(4-oxidobenzoyl)phenyl)acetate, sodium salt (1:2)
Sinônimos
N/A
Descrição
Impureza Bromfenac 25 (sal dissódico) é um subproduto iônico observado durante a síntese e purificação do bromfenac | tipicamente formado por neutralização incompleta ou transformação por hidrólise e troca iônica; apresenta perfil analítico distinto identificado por cromatografia líquida de alta eficiência HPLC e confirmado por LC-MS e espectroscopia NMR para estabelecer tempo de retenção | massa exata e sinais característicos. Sua presença impacta pureza | solubilidade e estabilidade do lote | exigindo monitoramento por métodos validados | limites de aceitação segundo ICH e estratégias de controle como troca iônica | ajuste de pH e etapas adicionais de purificação para remoção eficaz.
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