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79902-63-9 Simvastatin (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl 2,2-dimethyl-butanoate
Simvastatin (INN) 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.
1) The primary uses of simvastatin are for the treatment of dyslipidemia and the prevention ofcardiovascular
disease.
2) It also can used for the patient with coronary heart disease.
TEST |
STANDARD |
RESULT |
Characters |
White to off-white powder |
A white powder |
Identification |
|
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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