Impureza Diclofenac Chloroacetyl (Diclofenac Chloroacetyl Impurity | CAS 15308-01-7) | também conhecida como 2 | 2′ | 6′-Tricloro-N-fenilacetanilida ou N-(Cloroacetil)-2 | 6-dicloro-difenilamina | é um subproduto de reação caracterizado pela presença do grupo cloroacetil ligado ao anel diphenilamina. Esta impureza apresenta propriedades organocloradas que afetam polaridade e retenção em cromatografia | exigindo métodos analíticos sensíveis como HPLC-UV e LC-MS para quantificação e identificação. Conhecimento de sua via de formação e parâmetros de controle é crítico para o desenvolvimento e validação de processos | avaliação de estabilidade e conformidade com limites de qualidade | assegurando integridade do perfil impureza em lotes farmacêuticos.
Referências
Orlandini, S., et al. “A Comprehensive Strategy in the Development of a Cyclodextrin-Modified Microemulsion Electrokinetic Chromatographic Method for the Assay of Diclofenac and Its Impurities: Mixture-Process Variable Experiments and Quality by Design.†Journal of Chromatography A, vol. 1466, Sept. 2016, pp. 189–98, https://doi.org/10.1016/j.chroma.2016.09.013.?Davies, Neal M., and Keith E. Anderson. “Clinical Pharmacokinetics of Diclofenac.†Clinical Pharmacokinetics, vol. 33, no. 3, Sept. 1997
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