98% up by HPLC, GMP,DMF,CEP Ezetimibe 163222-33-1

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98% up by HPLC, GMP,DMF,CEP Ezetimibe 163222-33-1
CAS No.:163222-33-1
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • 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.

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