Impureza de diclofenac desacetato (CAS 15307-93-4) | conocida también como 2 | 6-dichloro-N-phenylaniline | Diclofenac 2 | 6-dichlorodiphenylamine o N-Phenyl-2 | 6-dichloroaniline | constituye un elemento crítico en el perfil de impurezas de formulaciones que contienen diclofenac desacetato. Desde el punto de vista analítico requiere detección y cuantificación por técnicas cromatográficas y espectrométricas validadas: HPLC con detección UV/DAD | LC-MS o RMN para confirmación estructural. Su presencia puede indicar rutas de síntesis incompletas o procesos de degradación y afecta límites de especificación | estabilidad y cumplimiento regulatorio. Se recomienda monitoreo riguroso | métodos validados y estrategias de control durante desarrollo y producción | incluyendo cuantificación en niveles traza y criterios para la aceptación de lotes.
Referencias
Banaschik, Robert, et al. “Degradation and Intermediates of Diclofenac as Instructive Example for Decomposition of Recalcitrant Pharmaceuticals by Hydroxyl Radicals Generated with Pulsed Corona Plasma in Water.†Journal of Hazardous Materials, vol. 342, Jan. 2018, pp. 651–60, https://doi.org/10.1016/j.jhazmat.2017.08.058. Orlandini, S., et al. “A Comprehensive Strategy in the Development of a Cyclodextrin-Modified Microemulsion Electrokinetic Chromatographic Method for the Assay of Diclofenac an
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