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DMF No.: 030167
Name: sulfobutyl ether-beta-cyclodextrin sodium salt
Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula : C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Solubility(in 100cm3 solvent, at 25℃) : water:>50g
Methanol:<0.5g
Acetone :<0.5g
Qaulity ： injection grade / oral grade
Standard : USP39
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized
Use : medical
Specification : USP39
ITEMS |
SPECIFICATION |
RESULTS |
Appearance |
White to off-white solid, free from foreign matter |
Qualify |
Solution Clarity |
A 30%w/v solution in water is clear and essentially free from particles of foreign matter |
Qualify |
Identification (IR) |
Consistent with SBECD standard |
Qualify |
Sodium Identification |
Identify test are positive for Sodium |
+ |
Average Degree of Substitution |
6.2-6.9 |
6.7 |
SBE 1 Content |
≤0.2% |
0.05% |
SBE 2 Content |
≤0.8% |
0.15% |
Water solution pH |
pH of 30%w/v solution in water is 4.0-6.8 |
5.4 |
Heavy Metals |
≤5ppm |
<5ppm |
Water |
≤10% |
4.0% |
β-Cyclodextrin Content |
≤0.1% |
Absence |
Sodium Chloride |
≤0.2% |
0.01% |
1,4-butane sultone |
≤0.5ppm |
0.3ppm |
4-Hydroxybutane-1-Sulfonic Acid |
≤0.09% |
0.01% |
Disodium bis-(4-sulfobtyl) ether |
≤0.05% |
0.05% |
Assay |
95%-105% |
99.5% |
Bacterial endotoxins |
≤25EU/g |
≤20EU/g |
Microbiology | ||
Total viable aerobic count (mould plus yeast) |
≤100CFU/g |
20CFU/g |
Escherichia Coli |
Absence |
Absence |
Salmonella species |
Absence |
Absence |
mould plus yeast |
≤50CFU/g |
Absence |
Features and applications:
SBE-β-CD 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.
SBE-β-CD 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.
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