Sulfobutyl Ether-beta-cyclodextrin Sodium Salt

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Description

Product Detail

DMF No.: 030167

Name: Sulfobutyl ether-beta-cyclodextrin sodium salt

Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-ß-cyclodextrin sodium salt

CAS: 182410-00-0

Abbreviation: SBEBCD

Molecular formula : C₄₂H_70-nO₃₅ (C₄H₈O₃S Na)n

Molecular weight: 1135+158n

Qaulity : injection grade

Standard : USP40-NF35

Package: 500g/bag,1kg/bag,2kg/bag,10kg/drum,20kg/drum or customized

Use : medical

Specification : USP40-NF35

Standard	USP40-NF35
ITEMS	SPECIFICATION
Clarity of Solution	A 30%w/v solution in water is clear
Identification (IR)	Same absorption bands as USP betadex sulfobutyl ether sodium RS
Identification(Sodium)	Identify test are positive for Sodium
Identification(LC)	the retention time of the major peak of sample solution corresponds to the standard solution
Average Degree of Substitution	6.2-6.9
Water solution pH	pH of 30%w/v solution in water is 4.0-6.8
Heavy Metals	=5ppm
Water content	=10.0%
ß-Cyclodextrin Content	=0.1%
Sodium Chloride	=0.2%
1,4-butane sultone	=0.5ppm
4-Hydroxybutane-1-Sulfonic Acid	=0.09%
Disodium bis-(4-sulfobtyl) ether	=0.05%
Assay	95.0%-105.0%
Bacterial endotoxins	=20EU/g
Microbiology
TAMC ( cfu/g)	=100 cfu/g
TYMC ( cfu/g)	=50 cfu/g
Escherichia Coli	Absence

Features and applications:

sulfobutyl ether-beta-cyclodextrin sodium salt is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.

sulfobutyl ether-beta-cyclodextrin sodium salt has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.