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Simvastatin |
Appearance: White or off-white crystal or crystalline powder
Specification:
Specific optical rotation: +285- +298
Identification: A. IR
B. The retention time of the major in the chromatogram of the assay preparation corresponds to that in chromatogram of the standard preparation.
Loss on drying: 0.5% max
Residue on ignition: 0.1% max
Heavy metals: 0.002% max
Chromatogram purity: total impurities: 1.0% max
Major impurities: 0.4% max
Limit of lovastatin: 1.0% max
Methanol: 3000ppm max
Ethanol: 5000ppm max
Dichloromethane: 600ppm max
Ethylacetate: 5000ppm max
Tetrahydrofuran: 720ppm max
N, N-Dimothylformamide: 880ppm max
Assay: 98.0-101.0%
Usage:Antihyperlipidemic
Packing: 25kg per drum
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