Fondaparinux sodium 114870-03-0

95%-103%

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Product Details

Product Information

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
Identification	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.