Aceclofenac EP Impurity A (Sodium Salt) (CAS 15307-79-6) é uma impureza orgânica aniónica frequentemente detectada em lotes de aceclofenaco e produtos relacionados. Quimicamente correlacionada com o sal sódico do ácido o-(2 | 6-dicloroanilino)fenilacético | pode surgir por hidrólise | transesterificação ou reações secundárias durante síntese | purificação ou armazenamento. Sua identificação e quantificação por HPLC com detecção UV e confirmação por LC-MS são essenciais para cumprir especificações farmacopoeicas e avaliação de segurança. Características relevantes incluem maior solubilidade em meio aquoso na forma iônica | sensibilidade a condições ácidas e térmicas e necessidade de limites de aceitação bem definidos no controle de qualidade.
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.
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