Rosuvastatin (6R)-Isomer Calcium Salt, CAS 854898-49-0, is a stereochemical impurity of the statin active pharmaceutical ingredient in which inversion at the C6 center yields a configurational isomer rather than a degradation fragment. With molecular formula C22H27CaFN3O6S and molecular weight 520.6 g/mol, it retains the calcium salt form and the pyrimidinyl sulfonamide pharmacophore, so discrimination from the parent drug depends on stereoselective separation. Formation may arise during synthesis or epimerization under acidic or thermal stress. Quantification typically requires chiral HPLC coupled to LC-MS/MS, and orthogonal NMR confirmation may be necessary.
References
Luvai, A., Mbagaya, W., Hall, A. S., & Barth, J. H. (2012). Rosuvastatin: A Review of the Pharmacology and Clinical Effectiveness in Cardiovascular Disease. Clinical Medicine Insights: Cardiology, 6, CMC.S4324. https://doi.org/10.4137/cmc.s4324
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