01
Rosuvastatin Calcium 147098-20-2
Product Specification
| Appearance： | White to off- white, hygroscopic powder |
| Solubility： | Slightly soluble in water, freely soluble indichloromethane, almost insoluble inanhydrous ethanol |
| Identification (lR)： | To match with working standard |
| Identification(The retention timeOfEnantiomeric purity)： | RRT at about 25min |
| Water： | NMT6.1% |
| Enantiomeric purity： | NMTO.10% |
| Assay： | 97.0%~102.0% |
description1
PRODUCT DESCRIPTION
Rosuvastatin calcium is an anti-hyperlipidemia drug which belongs to the inhibitor of HMG-CoA reductase successfully developed by the British AstraZeneca company. 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.
Rosuvastatin is a selective inhibitor of HMG-CoA reductase. HMG-CoA reductase inhibitor is the rate-limiting enzyme of the transition hydroxy-3-methylglutaryl coenzyme A to valerate A (The precursor of cholesterol). The main site of action of rosuvastatin is liver-the target organs of cholesterol-lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell surface, promoting the absorption and catabolism of LDL, inhibits hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
For patients of homozygous and heterozygous familial hypercholesterolemia, non-familial hypercholesterolemia, and mixed dyslipidemia, Rosuvastatin can lower the total cholesterol, LDL-C levels, ApoB levels, non-HDL-C levels. Rosuvastatin also reduces the level of TG and increase the level of HDL-C. For patients of pure hypertriglyceridemia, rosuvastatin can lower total cholesterol, LDL-C, VLDL-C, ApoB, non-HDL-C, TG levels and increase the HDL-C levels.
Based on the general safety of pharmacology, repeated dose toxicity, potential genetic toxicity and the clinical information of carcinogenicity, no special toxicity was found for rosuvastatin on the human body. For studies on rat before and after birth, Rosuvastatin has obvious reproductive toxicity. It reduces the size, weight of the litter and birth rate. Treating female rats with a toxic dose which causes several times higher systemic exposure levels than the therapeutic exposure can enable the observation of these phenomena.
The above information is edited by the Chemicalbook of Dai Xiongfeng.