Atorvastatin EP Impurity B (Free Base)、CAS 842103-12-2 は、アトルバスタチンカルシウムの製造経路およびプロセス条件やストレス条件下でのスタチン側鎖変換に関連する、構造関連性の高い合成不純物である。分子式 C33H35FN2O5、分子量 558.65 g/mol を有し、フルオロフェニル置換ピロール骨格を保持する一方、立体配置または置換様式が原薬と異なるため、クロマトグラフィー挙動と不純物プロファイルに影響する。定量には通常、逆相LCとUV検出、LC-MS/MS、または高分解能MSが必要であり、NMRによる補完的同定や、必要に応じてLC-ELSD、HPLC-UVによる微量分析が行われる。
References
McIver, L. A., & Siddique, M. S. (2022, September 2). Atorvastatin. Retrieved October 31, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK430779/
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