Atorvastatin EP Impurity C, auch als Atorvastatin Related Compound C, Atorvastatin Difluoro Impurity oder Fluoroatorvastatin bezeichnet, ist ein fluoriertes Atorvastatin-Analogon als Calciumsalz (CAS 693793-53-2). Mit der Summenformel C66H66CaF4N4O10 und einer Molmasse von 1191,34 g/mol weist es eine Halogensubstitution im aromatischen Substitutionsmuster des Statin-Gerüsts auf und ist somit kein einfacher Abbauprodukt. Solche Spezies entstehen typischerweise durch synthetische Verunreinigungseinträge oder Fehlinkorporation in späten Kupplungsstufen und erfordern zur Identifizierung und Gehaltsbestimmung orthogonale Verfahren wie LC-MS/MS, hochauflösende MS sowie vorzugsweise 19F-NMR in Kombination mit LC-UV.
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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