Product name | Rosuvastatin Calcium |
CAS No. | 147098-20-2 |
Molecular Formula | C44H54CaF2N6O12S2 |
Molecular Weight | 1001.14 |
Quality Standard | 97% up by HPLC, GMP,DMF,CEP, EP |
Appearance | White or almost white powder |
COA of Rosuvastatin Calcium |
ITEMS | SPECIFICATION | RESULT |
Appearance | White or almost white hygroscopic powder | Conforms |
Identity | IR: Similar to Reference Substance | Conforms |
Enantiomeric purity | Conforms |
It gives reaction (b) of calcium | Positive reaction |
Related substance | Impurity A ≤ 0.2% Impurity B ≤ 0.5% Impurity C ≤ 0.8% Unknown impurity ≤ 0.1% Total impurity ≤ 1.2% | Undetected Undetected Undetected Undetected Undetected |
Enantiomer | Impurity G ≤ 0.10% | Undetected |
Water | ≤ 0.60% | 1.2% |
Assay | 97.0～102.0%(anhydrous substance ) | 99.9% |
Conclusion | The results above meet all requirements under EP8.4
|
Function of Rosuvastatin calcium
Rosuvastatin calcium is an anti-hyperlipidemia drug which belongs to the inhibitor of HMG-CoA reductase successfully. It is suitable for the treatment of various lipid abnormalities, including hypercholesterolemia, mixed lipid qualitative abnormalities and simple hypertriglyceridemia. Rosuvastatin calcium is listed as the strongest and the most comprehensive statins drugs which has entered into market for lipid-lowering and adjustment. Compared with atorvastatin which is currently recognized with the world's best efficacy, it has a better effect of lowering the level of LDL cholesterol and increasing the level of high-density lipoprotein. Moreover, it has a better tolerance, lower side effects and unique pharmacokinetic characteristics with the half-life about 20h. It only needs to be taken once a day.
