La impureza Diclofenac Isopropyl Ester (CAS 66370-79-4) | también conocida como Isopropyl 2-[2-(2 | 6-dichloroanilino)phenyl]acetate | es un contaminante de proceso identificado en la síntesis de diclofenaco | formado durante la esterificación o por transesterificación con isopropanol; su presencia afecta la pureza del principio activo y la estabilidad del lote. Desde un punto de vista analítico requiere control por HPLC con detección UV y confirmación por LC-MS o espectrometría de masas y RMN para identificación estructural. El monitoreo riguroso y la optimización de condiciones de reacción | purificación y límites de especificación son esenciales para garantizar cumplimiento de calidad y minimizar riesgos toxicológicos y de impurezas relacionadas.
Referencias
“Synthesis of Various Esters of Diclofenac (NSAIDs) as Pro-Drugs and Their Biological Evaluation.† E-Journals.in, 2021, www.e-journals.in/abstract3.asp?Totarticle=745.
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