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Sinoway Industrial Co.Ltd.
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Product name
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Ezetimibe
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CAS No.
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163222-33-1
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Molecular Formula
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C24H21F2NO3
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Molecular Weight
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409.43
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Quality Standard
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98% up by HPLC, GMP,DMF,CEP
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Appearance
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White powder
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ITEMS
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SPECIFICATION
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RESULT
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Appearance
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White powder
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Conforms
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Specific rotation
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-25.0。~ -29.0。
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-26.2。
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Melting range
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160。C ~167。C
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163。C~166。C
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Identity
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Retention time: Similar to Reference Substance
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Conforms
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IR: Similar to Reference Substance
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Conforms
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Chloride
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≤ 0.01%
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Conforms
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Loss on drying
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≤ 0.5%
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0.11%
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Sulphated Ash
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≤ 0.1%
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0.01%
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Enantiomer
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≤ 0.15%
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Undetected
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Diastereomer
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≤ 0.15%
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Undetected
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Heavy metals
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≤ 10 ppm
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Conforms
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Related substances
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Single impurity ≤ 0.10%
Total impurity ≤ 1.0%
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0.06%
0.2%
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Residual solvents
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Methanol ≤ 3000ppm
Isopropanol ≤ 5000ppm
Chlorobenzene ≤ 360ppm
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Undetected
351ppm
Undetected
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Assay
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98.0～102.0%(calculated on the dried basis )
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99.9%
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Conclusion
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The results above meet all requirements under Ezetimibe in In-House Standard.
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Function of Ezetimibe
Ezetimibe is ananti-hyperlipidemic drug used for lowering the plasma cholesterol levels. It is indicated as an adjunctive therapy to diet for the reduction of high-level total-C, LDL-C, and ApoB in patients suffering primary (heterozygous familial and non-familial) hypercholesterolemia. It is also used in combination therapy with HMG-CoA reductase inhibitors.Ezetimibe does not inhibit the cholesterol synthesis in the liver, or increase bile acid excretion.Instead, ezetimibe takes effect throughacting at the brush border of the small intestine and inhibiting the absorption of cholesterol, further leading to a decrease in the delivery of intestinal cholesterol to the liver, This causes a reduction of hepatic cholesterol stores and an increase in clearance of blood cholesterol.
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