Diclofenac Dodecyl Ester como impureza presenta propiedades lipofílicas que afectan el perfil de pureza y la estabilidad del lote; puede generarse durante pasos de esterificación o transesterificación y es detectable por HPLC y LC-MS | con confirmación estructural mediante RMN y FTIR. Su presencia impacta parámetros críticos como solubilidad aparente | potencia y perfil de degradación | por lo que exige monitoreo cuantitativo | definición de límites de especificación y estudios de estabilidad forzados. Las estrategias de control incluyen purificación cromatográfica | optimización de las condiciones de reacción y validación analítica para garantizar cumplimiento regulatorio y minimizar riesgos asociados a esta impureza en el producto final.
Referencias
“Improved Ex Vivo Transcutaneous Permeation of Diclofenac from Solid Lipid Nanoparticles in the Presence of Novel Long-Chain Alkyl Esters of PABA.†Journal of Dispersion Science and Technology, 2011, www.tandfonline.com/doi/abs/10.1080/01932691.2010.498248.Sallmann, Alfred R. “The History of Diclofenac.†The American Journal of Medicine, vol. 80, no. 4, Apr. 1986, pp. 29–33, https://doi.org/10.1016/0002-9343(86)90076-8.
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