99% up Fondaparinux Sodium 114870-03-0

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99% up Fondaparinux Sodium 114870-03-0
CAS No.:114870-03-0
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 name

    Fondaparinux sodium

    CAS No.

    114870-03-0

    Molecular Formula

    C31H43N3O49S8*10Na

    Molecular Weight

    1728.1

    Molecular Structure

    Quality Standard

    95%-103%

    Appearance

    White or off- white powder

     

    COA

     

    ANALYSIS

    SPECIFICATION

    RESULTS

    Appearance

    White or off-white powder

    White powder

    Solubility

    Very soluble in water

    Very soluble in water

    Specific rotation

    +50° ~+65°

    58.5°

    Identification

    HPLC: The sample main peak Retention time shall matches with standard main peak Retention time in the Assay Determination Chromatogram.

    Conforms

    IR: The infrared absorption spectrum of the sample shall be concordant with that of Cannabidiol standard spectrum.

    Conforms

     

    Na: The sample main peak Retention time shall matches with standard main peak Retention time in the Sodium Determination Chromatogram.

    Conforms

    pH

    6.0-8.0

    7.4

    Appearance of solution

    The solution is clear and colourless

    Conforms

    Sodium

    11.5%-15.0%

    13.2%

    Related substances

    Impurity A  0.3%

    0.04%

    Impurity B  0.3%

    ND

    Any unspecified Impurity  0.3%

    0.03%

    Total Impurity  2.0%

    0.07%

    Free sulfate and chloride

    Free sulfate  0.30%

    Chloride  1.0%

    0.09%

    0.05%

    Residual solvents

    Pyridine  50 ppm

    Toluene  200 ppm

    ND

    ND

    Water

    < 15%

    9.2%

    Palladium

    < 1ppm

    <0.05ppm

    Heavy metals

    < 20 ppm

    Conforms

    Microbial limit

    Total Aerobic Bacteria Count < 100cfu/g

    Total Mold & Yeast Count< 100cfu/g

    < 10cfu/g

    < 10cfu/g

    Bacterial Endotoxins

    Not more than 3.3EU/mg

    Conforms

    Assay

    95.0%-103.0% (on anhydrous basis&solvent free basis)

    99.5%

    Conclusion

    The product meets specification

     

    Usage

     

    What is Fondaparinux Sodium?


    Fondaparinux Sodiumis a generic drug used to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).  Fondaparinux Sodium is used together with another anticoagulant to stop the blood clotting substance in the in the blood. This reduces the risk of heart attack, stroke, or breathing problems.

    Some of the advantages with fondaparinux are its chemical nature of synthesis, minimal risk of contamination, 100% absolute bioavailability subcutaneously, instant onset of action, a long half-life, direct renal excretion, fewer adverse reactions when compared with direct oral anticoagulants.

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