1-(2 | 6-Dichlorophenyl)isatin (CAS 24542-74-3) es una impureza relacionada de tipo isatina que puede formarse durante la s?ntesis y transformaci?n de diclofenac y compuestos an?logos; su detecci?n temprana es cr?tica en control de calidad. La presencia de esta impureza altera el perfil de pureza y puede interferir en ensayos anal?ticos si no se cuantifica adecuadamente. Se recomienda monitorizarla mediante HPLC-UV con confirmaci?n por LC-MS y caracterizaci?n estructural por NMR. Las estrategias de control incluyen optimizaci?n de condiciones de reacci?n | purificaci?n cromatogr?fica y establecer l?mites en especificaciones para mitigar riesgos y asegurar cumplimiento regulatorio.
Referencias
Cwiertnia, Barbara, et al. “Stability of Diclofenac Sodium in the Inclusion Complex with v-Cyclodextrin in the Solid State.” Journal of Pharmacy and Pharmacology, vol. 51, no. 11, Nov. 1999, pp. 1213–18, https://doi.org/10.1211/0022357991776930 “Diclofenac: An Update on Its Mechanism of Action and Safety Profile.” Current Medical Research and Opinion, 2021, www.tandfonline.com/doi/abs/10.1185/03007995.2010.486301.
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