La impureza cloroacetil de diclofenaco (CAS 15308-01-7) | conocida también como 2 | 2′ | 6′-Tricloro-N-fenilacetanilida o N-(Cloroacetil)-2 | 6-diclorodifenilamina | es una impureza sintética relevante en procesos de fabricación de diclofenaco. Su estructura cloroacetilada y sustitución triclorada confieren mayor lipofilia y potencial retención en fases cremas y sólidos. Se monitorea por cromatografía líquida de alta resolución | espectrometría de masas y resonancia magnética nuclear para identificar su perfil y cuantificar niveles traza. La presencia de esta impureza puede afectar pureza | estabilidad y cumplimiento de especificaciones regulatorias | por lo que se establecen límites de control | métodos de eliminación y estudios de degradación dirigidos.
Referencias
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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