Impureza de Diclofenac 23 (CAS 131023-44-4) | designada como 8-Cloro-9H-carbazole-1-acetic Acid | é um derivado clorado do núcleo carbazol que surge como impureza relacionada em perfis de diclofenaco; sua detecção e quantificação são críticas para garantia de qualidade. Este componente é tipicamente monitorado por HPLC com detecção UV | LC-MS e RMN para identificação estrutural e determinação de níveis. A ocorrência pode decorrer de subprodutos de síntese ou degradação e requer definição de especificações | investigação de origem e qualificação toxicológica conforme ICH Q3A/Q3B e Boas Práticas | apoiando avaliação de estabilidade e limites aceitáveis.
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