China Antihyperlipidemic Simvastatin CAS No 79902-63-9, Find details about China Simvastatin, 79902-63-9 from Antihyperlipidemic 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% |