Amlodipine EP Impurity D は、Amlodipine Related Compound A のベシル酸塩としても表される、ジヒドロピリジン系カルシウム拮抗薬アムロジピンに関連する既知の有機プロセス不純物および分解不純物である。CAS 2733700-89-3、分子式 C26H29ClN2O8S、分子量 565.04 g/mol を有し、ベンゼンスルホン酸塩対イオンを伴う塩形として存在する。生成は原薬合成、塩形成、またはジヒドロピリジン核の酸化変換に起因しうる。定量には通常、HPLC または UPLC による分離に加え、LC-MS/MS による確認、必要に応じて HRMS による構造解析が用いられる。薬局方および ICH の不純物管理の枠組みで重要である。
References
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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