High Quality Rosuvastatin 289042-12-2 , Rosuvastatin calcium 147098-20-2 Introduction Rosuvastatin is a member of pharmaceutical class known as statins, used for lowering blood cholesterol and antihyperlipidemia. Product Name Rosuvastatin Chemical Name 7-{4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid CAS Number 287714-41-4 Molecular Formula C22H28FN3O6S Storage Kept in well-closed container with nitrogen gas, protected from light Function Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to other statins. Its approximate elimination half life is 19 hours and its time to peak plasma concentration are reached in 3–5 hours following oral administration. Putative beneficial effects of rosuvastatin therapy on chronic heart failure may be negated by increases in collagen turnover markers as well as a reduction in plasma Coenzyme Q10 (CoQ10) levels in patients with chronic heart failure. Application 1. Rosuvastatin is suitable for primary hypercholesterolemia (Ⅱa type, including heterozygous familial hypercholesterolemia) or mixed blood lipid disorders (Ⅱb type) patients in the adjuvant treatment of dieting or exercise therapy is not an ideal time. 2. Rosuvastatin can reduce elevated LDL cholesterol, total cholesterol, triglycerides and ApoB, increased HDL- cholesterol. 3. Rosuvastatin also applies to homozygous familial hypercholesterolemia, or can be used with diet or other lipid-lowering means (such as LDL removal method) used alone. Specification Tests Specification Results Appearance White to off-white powder Off-white powder Specific optical rotation +14 ° - +20° +19.19° Solubility Slightly soluble in acetonitrile water,very slightly soluble in ethanol Conforms Identification Calcium salts identification Uv Ir Conforms Conforms Conforms Related substance(hplc) Highest unknow impurity Oxo compound of rosuvastatin Lactone of rosuvastatin Enantiomer of rosuvastatin Non-enantionmer of rosuvastatin Total impurity Not more than 0.3% Not more than 0.1% Not more than 0.2% Not more than 0.1% Not more than 0.3% Not more than 1.0% 0.13% N/d N/d N/d 0.17% 0.6% Loss on drying Not more than 5.0% 2.6% Heavy metals Not more than 10ppm Conforms Ca content ( % w/w) 3.8-4.2% 4.1% Assay (% w/w ,by hplc) ≥99.0% 99.4% Conclusion It conforms to enterprise standard, Our Conpect 1.Client is first.We are trying to bring maximum profit to our clients and we only share small. 2.Credibility is the most important. 3.Quality control is our life. 4.Great sense of responsibility. We will be responsible for not only our products, our clients, our suppliers, also the society.
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