Diclofenac PPG Ester 2 es una impureza derivada de la esterificación parcial del diclofenaco con unidades de propilenglicol que altera el perfil fisicoquímico del material activo; presenta mayor masa molar y una distribución de polaridad distinta frente al ácido libre | lo que impacta retención cromatográfica y solubilidad. Su identificación y cuantificación se realizan por HPLC con detección UV y confirmación por LC-MS y RMN para elucidación estructural. Se recomienda monitorear esta impureza dentro del control de calidad mediante métodos validados | establecer límites de aceptación basados en toxicología comparativa y optimizar pasos de purificación y condiciones de almacenamiento para minimizar su formación y degradación por hidrólisis.
Referencias
“Preparation and Characterization of PEG-Modified Polyurethane Pressure-Sensitive Adhesives for Transdermal Drug Delivery.†Drug Development and Industrial Pharmacy, 2021, www.tandfonline.com/doi/abs/10.1080/03639040802512235.?Todd, Peter A., and Eugene M. Sorkin. “Diclofenac Sodium.†Drugs, vol. 35, no. 3, Mar. 1988, pp. 244–85, https://doi.org/10.2165/00003495-198835030-00004.
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