Simvastatin CAS NO:79902-63-9 CAS NO.79902-63-9

Product Details

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	ir	conforms
identification	hplc	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%