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Simvastatin has the effect of lowering cholesterol, low density lipoprotein. Simvastatin catalyzes the conversion of β-methyl-β-hydroxyglutaric acid coenzyme A (HMG-CoA) to β methyl-p-α dihydroxyvalerate, and is a specific inhibitor of HMG-CoA reductase. Simvastatin is used in primary hypercholesterolemia, heterozygous familial and nonfamilial hypercholesterolemia, or mixed hyperlipidemia that do not respond well to dietary therapy, and has a significant effect on reducing total cholesterol and LDL cholesterol.
| Items | Specification | Result |
| Assay | 97%-102% | 98.7% |
| Appearance | White or almost white crystalline powder | Almost white crystalline powder |
| Specific optical rotation | +285°~+300° | +291.2° |
| Related substance | Impurity A≤0.4% Impurity D≤0.4% Impurity G≤0.1% Any unspecified impurity≤0.1% Total impurities≤1.0% | 0.06% 0.09% 0.05% 0.09% 0.53% |
| Loss on drying | ≤0.5% | 0.03% |
| Heavy metals | ≤20ppm | <20ppm |
| Sulphated ash | ≤0.1% | 0.03% |
| Product parameters | |
| Cas number: | 79902-63-9 |
| Appearance: | White or almost white crystalline powder |
| Purity: | 97%-102% |
| Package details: | 1kg/foil bag;25kg/drum |
| Brand: | Fortunachem |
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