Aceclofenac EP Impurity B (CAS 15307-78-5) | conhecido como éster metílico do diclofenaco | é uma impureza identificada em matérias-primas e produtos acabados que resulta de reações de esterificação ou de degradação durante síntese e armazenamento. A presença desta impureza compromete a pureza e o perfil de segurança do lote e exige monitorização analítica rigorosa. Métodos cromatográficos e espectrométricos validados | como HPLC com detectores UV | LC-MS e RMN | são recomendados para identificação e quantificação | com uso de padrão de referência para verificação de pico. Controles de processo e estudos de estabilidade são essenciais para manter níveis dentro dos limites farmacopéicos aplicáveis.
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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