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Simvastatin

Simvastatin

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PRODUCT NAME: Simvastatin
CAS NUMBER: 79902-63-9
Simvastatin is a hypolipidemic drug used with exercise, diet, and weight-loss to control elevated cholesterol, or hypercholesterolemia. It is a member of the statin class of pharmaceuticals. Simvastatin is a synthetic derivative of a fermentation product of Aspergillus terreus.

MP 139°C
storage temp.
0-6°C
Lipid-lowering drugs Simvastatin is a cholesterol-lowering drug of statin, is a synthetic derivative of Aspergillus terreus fermentation product, is used to control blood cholesterol levels and prevent cardiovascular disease.
Simvastatin belongs to methyl hydroxyl coenzyme A (HMG-COA) reductase inhibitors, inhibits synthesis of endogenous cholesterol, and is the lipid regulator. Has a role in reducing cholesterol (TC) content of serum, liver and aorta in hyperlipidemia rabbits reducing levels of very low density lipoprotein cholesterol (VLDL-C) and low-density lipoprotein cholesterol (LDL-C).
Indications 1. Hyperlipidemia:
(1) For patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or mixed hypercholesterolemia, when diet and other non-drug treatment is not ideal, Simvastatin can be used to reduce the increased total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides. And Simvastatin increases high-density lipoprotein cholesterol, thereby reducing the LDL / HDL and total cholesterol / HDL ratio.
(2) For patients with homozygous familial hypercholesterolemia, when diet and non-diet is not ideal, Simvastatin can be used to reduce elevated total cholesterol, LDL cholesterol and apolipoprotein B.
2. Coronary heart disease:
Coronary heart disease, Simvastatin can be used to:
(1) reduce the risk of death.
(2) reduce risk of coronary heart disease death and nonfatal myocardial infarction.
(3) reduce risk of stroke and transient ischemic.
(4) reduce risk of myocardial revascularization (coronary artery bypass grafting and percutaneous coronary balloon angioplasty).
(5) delay the progression of atherosclerosis in the arteries, including the all-new lesions and the occurrence of full clogging.
Chemical properties White crystalline powder, odorless. Soluble in ethanol, acetone or acetonitrile, difficult soluble in ether, practically insoluble in water. Melting point is 135~138°C.
Toxicity grading Poisoning
Acute toxicity Oral – rat LD50: 4438 mg / kg; Oral – mouse LD50: 3000 mg /kg.
Flammability hazard characteristics Combustible; fire releases spicy smoke.
Storage characteristics Treasury is low temperature, ventilation, dry; in dark.
Extinguishing agent Water, carbon dioxide, dry, sandy soil.
Biological Activity HMG-CoA reductase inhibitor; decreases levels of low density lipoprotein. Has multiple biological effects including bone formation stimulation, inhibition of smooth muscle cell proliferation and migration, and anticancer and anti-inflammatory activity.
Application 1. HMG-CoA reductase inhibitors, can reduce the concentration of serum total cholesterol level, inhibit synthesis of cholesterol. For treatment of primary hypercholesterolemia with cholesterol levels greater than 7.8mmol / L which is invalid or not tolerated in other treatments.
2. Has role in reducing cholesterol, low-density lipoprotein cholesterol and very low density lipoprotein cholesterol.
Usage Simvastatin is semi-synthetic, slightly more hydrophobic, analogue of lovastatin. Like lovastatin, simvastatin is a specific inhibitor of HMG-CoA reductase and is used therapeutically to reduce LDL cholesterol. More recently, the statins have become important biochemical probes in cell biology. Their involvement in many events can be correlated to their primary mode of action, however, the mechanism of action of many other effects is less apparent.
TEST STANDARD RESULT
Characters White to off-white powder A white powder
Identification IR
HPLC
Conforms
Conforms
Specific optical rotation +285–+298° +290°
Solubility Practically insoluble in water; freely soluble in chloroform, in methanol, and in alcohol; Sparingly soluble in propylene glycol; very slightly soluble in hexane Conforms
Loss On drying ≤0.5 % 0.04%
Residue on Ignition ≤0.1% 0.04%
Heavy Metals ≤20ppm <20ppm
Chromatographic purity
Simvastatin hydroxyacid ≤0.4% 0.09
Lovastatin and epilovastatin ≤1.0% 0.38%
Methylene simvastation ≤0.4% 0.09%
Acetyl simvastatin ≤0.4% 0.05%
Anhydro simvastatin ≤0.4% 0.10%
Simvastatin dimer ≤0.4% 0.11%
Any other individual impurity ≤0.10% 0.03%
Total impurities (except lovastatin and epilovastatin) ≤1.0% 0.52%
Residual organic solvents
Methanol
Ethanol
Methylene chloride

≤3000ppm
≤5000ppm
≤600ppm

ND
574ppm
ND
Assay (on dry basis) 98.0-102.0% 99.3%

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