A Impureza C do Aceclofenaco (CAS 15307-77-4) | também chamada Aceclofenac Impurity C ou Aceclofenac BP Impurity C e conhecida por Diclofenac Ethyl Ester | ethyl 2-[2-(2 | 6-dichloroanilino)phenyl]acetate e outras designações | é um derivado etílico que aparece como impureza de síntese no controle de qualidade farmacêutico. Sua presença afeta a pureza do lote e a conformidade com monografias EP e BP | exigindo monitorização rigorosa por técnicas analíticas como HPLC com detecção UV | GC-MS e espectrometria de massas para quantificação e identificação estrutural. Avaliação de estabilidade | perfil de degradação e estabelecimento de limites de especificação são essenciais para minimizar risco ao processo produtivo e atender requisitos regulatórios.
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. Brogden, Rex N., and Lynda R. Wiseman. “Aceclofenac.” Drugs, vol. 52, no. 1, July 1996, pp. 113–24, https://doi.org/10.2165/00003495-199652010-00008. ?
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