Antihyperlipidemic Simvastatin CAS No 79902 -63-9

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

Model NO.
SAMREAL-0379
Trademark
samreal
Specification
20kg/drum, 25kg/drum
Origin
China
Model NO.
SAMREAL-0379
Trademark
samreal
Specification
20kg/drum, 25kg/drum
Origin
China
Simvastatin cas no 79902-63-9
itemsstandardsresults
characterswhite to off-white powderwhite powder
solubilitypractically insoluble in water,freely soluble in chloroform,methanol,and alcohol;sparingly soluble in propylene glycol;very slightly soluble in hexanepractically insoluble in water,freely soluble in chloroform,methanol,and alcohol;sparingly soluble in propylene glycol;very slightly soluble in hexane
identificationA.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 rotation285°~298°294°
Loss on drying≤0.4%0.1%
sulfated ash≤0.10%0.07%
heavy metals≤0.002%<0.002%
chromatographic puritysimvastatin 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 solventmethanol≤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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Antihyperlipidemic Simvastatin CAS No 79902-63-9Antihyperlipidemic Simvastatin CAS No 79902-63-9Antihyperlipidemic Simvastatin CAS No 79902-63-9Antihyperlipidemic Simvastatin CAS No 79902-63-9