Betadex Sulfobutyl Ether Sodium

        Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium can bewell combined with the drugmolecules to form non-covalent therebyenhancingthe stability, water solubility, and safety of the drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease rate, covering bad smell, etc.

[CAS NO]: 128410-00-0

DMF 034773

[Molecular formula]: C₄₂H_70-nO₃₅·(C₄H₈SO₃Na)_n

[Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.

[Category]: Pharmaceutical excipients

[Storage]: Seal preservation.

[Period of validity]: 36 months

Betadex Sulfobutyl Ether Sodium ( EP10.0)
【CONTENT】
Sulfobutyl Betadex Sodium	95.0%-105.0%
Average Degree of Substitution	5.9-6.6
【CHARACTERS】
Aooearancce	white or almost white, hygroscopic powder
Solubility	freely soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride
【IDENTIFICATION】
A Infraed Absorption Spectrophotometry	Complies with SBECD referance
B Sodium Reaction	Positive test for sodium
【TEST】
PH	5.0-7.5
Appearance of Solution	The solution is clear and colourless
Reducing Sugars	NMT 0.05%
【IMPURITIES】
Limit of betadex	NMT 0.1%
Limit of 1'2λ6-oxathiane-2,2-dione	NMT 0. 5ppm
Limit of 4-hydroxybutane-1-sulfonic acid	NMT 0. 1%
Limit of 4,4'-oxydi(butane-1-sulfonic acid)	NMT 0. 05%
Limit of soudiun chloride	NMT 0.12%
Water	NMT10.0%
【MICROBIAL CONTAMINATION】
the total aerobic microbial count	NMT 100cfu/g
the total combined molds and yeasts count	NMT 100cfu/g
Escherichia coli.	absence
Salmonella	absence