Amlodipine EP Impurity E (sal oxalato) | também conhecida como Amlodipine Related Compound E | é uma impureza isolada na via sintética da amlodipina caracterizada por sua forma salina oxalato e perfil físico-químico distinto; apresenta solubilidade diferenciada em solventes orgânicos polares e água | comportamento pH dependente e massa molecular consistente com modificações estruturais detectáveis por espectrometria de massa e ressonância magnética nuclear. Em análises de controle de qualidade mostra pico cromatográfico com tempo de retenção reproducível por HPLC e é relevante para avaliação do perfil de impurezas conforme especificações EP | exigindo qualificação analítica e estudos de estabilidade direcionados.
Referências
Sudhakar, P., et al. “Identification and Characterization of Potential Impurities of Amlodipine Maleate.†Journal of Pharmaceutical and Biomedical Analysis, vol. 40, no. 3, Feb. 2006, pp. 605–13, https://doi.org/10.1016/j.jpba.2005.10.029.?Jiang, Yuxuan, et al. “The Effect of Ion Pairing on the Skin Permeation of Amlodipine: Ingenta Connect.†Ingentaconnect.com, 2018, https://doi.org/info:doi/10.1691/ph.2008.7302.?
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