Amlodipine EP Impurity E (Maleate Salt) | CAS 400024-12-6 | também referida como Amlodipine Related Compound E | Amlodipine Ethyl Analog e Amlodipine Diethyl Ester Maleate | é uma impureza estrutural do tipo éster dietílico do análogo etílico de amlodipina na forma de sal maleato. Apresenta características físico-químicas relevantes para controle analítico | incluindo massa molecular específica | sinais espectrais distintos em HPLC-UV e espectrometria de massas e comportamento de ionização em LC-MS. A quantificação e identificação são críticas para conformidade com farmacopeias e limites de impurezas | exigindo métodos validados para estabilidade | pureza e perfil de degradação.
Referências
“Single-Dose, Randomized, Crossover Bioequivalence Study of Amlodipine Maleate versus Amlodipine Besylate in Healthy Volunteers.” Clinical and Experimental Hypertension, 2021, www.tandfonline.com/doi/abs/10.1080/10641960701744046.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.??
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