Atorvastatin EP Impurity C は、Atorvastatin Related Compound C、Atorvastatin Difluoro Impurity、または Fluoroatorvastatin とも呼ばれる、カルシウム塩型のフッ素化アトルバスタチン類縁体である（CAS 693793-53-2）。分子式は C66H66CaF4N4O10、分子量は 1191.34 g/mol であり、スタチン骨格の芳香族置換様式にハロゲンが導入された化学種で、単純な分解生成物ではない。通常は合成由来不純物の混入や後期カップリング工程での誤導入により生じ、同定と定量には LC-MS/MS、高分解能質量分析、さらに LC-UV 併用下の19F NMR が用いられる。
References
Agrawal, Deepak, et al. ‘To Study the Effect of High Dose Atorvastatin 40 Mg versus 80 Mg in Patients with Dyslipidemia.’ Indian Heart Journal, vol. 70, Dec. 2018, pp. S8–12, https://doi.org/10.1016/j.ihj.2018.01.034.
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