アムロジピン関連化合物Eは、Amlodipine EP Impurity E、Amlodipine Diethyl Ester、Amlodipine Ethyl Analogとも呼ばれ、ジヒドロピリジン系カルシウム拮抗薬アムロジピンの遊離塩基型エチルエステル類縁体である。CAS 140171-65-9、分子式C21H27ClN2O5、分子量422.9 g/molで示される。構造的にはカルボキシラート部位のアルキルエステル化体であり、分解生成物というより合成由来の副生成物またはエステル交換由来不純物として理解される。微量定量には通常、LC-MS/MS、LC-UVによる不純物プロファイリング、さらに高分解能MSを用いたHPLC確認が必要となる。
References
Sudhakar, P., et al. Identification and Characterization of Potential Impurities of Amlodipine Maleate.â€Â 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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