1-(2 | 6-Dichlorophenyl)isatin (CAS 24542-74-3) ? uma impureza clorada derivada da fam?lia dos isatinas | com propriedades f?sicas e espectrais que permitem sua identifica??o por HPLC-UV | LC-MS e RMN | al?m de determina??o por ponto de fus?o. Surge normalmente como subproduto de rea??es de acoplamento ou por oxida??o parcial durante etapas sint?ticas e pode comprometer o perfil de pureza e estabilidade do produto alvo. O monitoramento exige m?todos anal?ticos validados para quantifica??o tra?o a tra?o | estabelecimento de limites conforme ICH Q3A e estrat?gias de controle que incluam otimiza??o de etapas de purifica??o | controles em processo e testes de degrada??o for?ada para preven??o e mitiga??o.
Referências
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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