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Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
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.
Twenty years of qualification
Audited Supplier
Pharma Sources Insight JANUARY 2024
