Ezetimibe 163222-33-1

98% up by HPLC, GMP,DMF,CEP

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Product Details

Product Information

Product name	Ezetimibe
CAS No.	163222-33-1
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43
Quality Standard	98% up by HPLC, GMP,DMF,CEP
Appearance	White powder

COA of Ezetimibe

ITEMS	SPECIFICATION	RESULT
Appearance	White powder	Conforms
Specific rotation	-25.0^。~ -29.0^。	-26.2^。
Melting range	160^。C ~167^。C	163^。C~166^。C
Identity	Retention time: Similar to Reference Substance	Conforms
Identity	IR: Similar to Reference Substance	Conforms
Chloride	≤ 0.01%	Conforms
Loss on drying	≤ 0.5%	0.11%
Sulphated Ash	≤ 0.1%	0.01%
Enantiomer	≤ 0.15%	Undetected
Diastereomer	≤ 0.15%	Undetected
Heavy metals	≤ 10 ppm	Conforms
Related substances	Single impurity ≤ 0.10% Total impurity ≤ 1.0%	0.06% 0.2%
Residual solvents	Methanol ≤ 3000ppm Isopropanol ≤ 5000ppm Chlorobenzene ≤ 360ppm	Undetected 351ppm Undetected
Assay	98.0～102.0%(calculated on the dried basis )	99.9%
Conclusion	The results above meet all requirements under Ezetimibe in In-House Standard.

Usage

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.