La impureza Diclofenac keto Analog | Diclofenac Glyoxilic Acid (Free Base) (CAS 66156-75-0) | aparece como producto de degradación oxidativa o de ruta sintética incompleta en la fabricación de diclofenaco. Químicamente incorpora un grupo cetona y un ácido glicólico que aumentan la polaridad y alteran el comportamiento cromatográfico | provocando tiempos de retención diferenciados en HPLC reverso. Se caracteriza por espectros LC-MS con fragmentación específica | desplazamiento en UV y señales carbonílicas en NMR. Su control es crítico para estabilidad y cumplimiento regulatorio | por lo que se recomienda monitorización con HPLC-MS cuantitativa | límites basados en ICH y estudios de perfil de impurezas.
Referencias
Alfaro, Robert A., and Donald D. Davis. “Diclofenac.†Nih.gov, StatPearls Publishing, 3 June 2021, www.ncbi.nlm.nih.gov/books/NBK557879/. ‌
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