Bicalutamida Impureza G é uma impureza relacionada ao processo detectada em controles de qualidade de lotes de bicalutamida | caracterizada por comportamento cromatográfico e espectral distinto do princípio ativo. A sua identificação exige métodos analíticos validados | como HPLC-UV acoplada a LC-MS e análise de fragmentação para elucidação estrutural. Pode surgir por rotas de síntese ou degradação química | incluindo oxidação e hidrólise | e constitui parâmetro crítico em estudos de estabilidade. O controlo da Impureza G inclui quantificação sensível | definição de limites aceitáveis segundo ICH Q3A e investigação de sua toxicidade potencial para assegurar conformidade regulatória e qualidade do produto.
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