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98% up by HPLC, GMP,DMF,CEP Ezetimibe 163222-33-1
单价 面议对比
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发货 全国
过期 长期有效
更新 2025-08-13 23:43
 
详细信息

Grade: Pharmaceutical Grade

Factory Location: Xiamen, Fujian

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

Monthly Production Capacity: 1000kg

Packaging Information: 25kg/drum 1kg/bottle

Delivery Lead Time: 7 days after payment

Sample Provided: yes

Payment Terms: L/L

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

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.