Antihyperlipidemic Simvastatin CAS No 79902-63-9

• Function: Antihyperlipidemic
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Solid
• Volatile: Not Volatile
• Standard: USP, Ep
• Model NO.: SAMREAL-0379
• Transport Package: Drum
• Specification: 20kg/drum, 25kg/drum
• Trademark: samreal
• Origin: China

Product Description

Simvastatin cas no 79902-63-9

items	standards	results
characters	white to off-white powder	white powder
solubility	practically insoluble in water,freely soluble in chloroform,methanol,and alcohol;sparingly soluble in propylene glycol;very slightly soluble in hexane	practically insoluble in water,freely soluble in chloroform,methanol,and alcohol;sparingly soluble in propylene glycol;very slightly soluble in hexane
identification	A.IR:consistent with that obtained with simvastatin reference standard. B.the retention time of the major peak in the chromatogram of the assay preparation should correspond to that in the chromatogram of the standard preparation,as obtained in the assay.	A.IR:consistent with that obtained with simvastatin reference standard. B.the retention time of the major peak in the chromatogram of the assay preparation should correspond to that in the chromatogram of the standard preparation,as obtained in the assay.
specific optical rotation	285°~298°	294°
Loss on drying	≤0.4%	0.1%
sulfated ash	≤0.10%	0.07%
heavy metals	≤0.002%	<0.002%
chromatographic purity	simvastatin hydroxyacid≤0.4%; epilovastatin and lovastatin≤1.0%; methylene simvastatin≤0.4% acetyl simvastatin≤0.4% anhydro simvastatin≤0.4% simvastatin dimer≤0.4% any other individual impurity≤0.10% total impurities other than lovastatin and epilovastatin≤1.0%	simvastatin hydroxyacid:0.1%; epilovastatin and lovastatin:0.2%; methylene simvastatin:BDL; acetyl simvastatin:0.1% anhydro simvastatin:BDL; simvastatin dimer:BDL; any other individual impurity:BDL; total impurities other than lovastatin and epilovastatin:0.2%
residual organic solvent	methanol≤3000ppm ethanol≤5000ppm ethy acetate≤5000ppm dichloromethane≤600ppm tetrahydrofuran≤720ppm cyclohexane≤3880ppm N,N-dimethylformamide≤880ppm	methanol:BDL ethanol:157PPM ethy acetate:BDL dichloromethane:BDL tetrahydrofuran:BDL cyclohexane:BDL N,N-dimethylformamide:BDL
assay(dried substance)	98.2%~101.8%	99.3%

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