2-(2-(2-(2-(2-(2,6-Dichlorophenylamino)phenyl)-acetoxy)acetoxy)acetoxy)acetic acid; Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, 2-(2-(carboxymethoxy)-2-oxoethoxy)-2-oxoethyl ester; Aceclofenac Impurity H
Descrição
Aceclofenac EP Impurity H (CAS 1216495-92-9) | também denominada Diacetic Aceclofenac | é uma impureza processual identificada por sua estrutura éster múltipla com grupos carboxílicos e o fragmento 2 | 6-dicloroanilina; sua presença exige caracterização por técnicas analíticas robustas como HPLC com detecção UV | LC-MS e RMN para confirmação de massa | padrões de fragmentação e quantificação. As propriedades fisicoquímicas indicam polaridade elevada e propensão à hidrólise de ésteres | afetando estabilidade e perfil de degradação. Monitoramento rigoroso desta impureza é essencial para conformidade com especificações EP e controle de qualidade do princípio ativo.
Referências
Karbhari, PradnyaA, et al. “RP-LC Gradient Elution Method for Simultaneous Determination of Thiocolchicoside, Aceclofenac and Related Impurities in Tablet Formulation.” Journal of Pharmacy and Bioallied Sciences, vol. 6, no. 4, 2014, p. 246, https://doi.org/10.4103/0975-7406.142955. Dooley, Mukta, et al. “Aceclofenac.” Drugs, vol. 61, no. 9, 2001, pp. 1351–78, https://doi.org/10.2165/00003495-200161090-00012. ?
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