Diclofenac Related Compound 1 (CAS 928343-25-3) | identificado como ácido benzeneacético 2-[(2 | 6-dicloro-3-hidroxifenil)amino] ou 2-[(2 | 6-dicloro-3-hidroxifenil)amino]ácido benzeneacético | é uma impureza estrutural relacionada ao diclofenaco que requer monitoramento analítico rigoroso. Apresenta propriedades físico-químicas que incluem grupos fenólicos e amino que afetam sua polaridade e estabilidade | favorecendo formação por oxidação ou reações de acoplamento durante síntese e armazenamento. Métodos cromatográficos e espectrométricos são recomendados para quantificação e identificação de traços. Controle de processo | testes de pureza e limites aceitáveis estabelecidos por farmacopéias minimizam riscos à qualidade do produto final.
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