pharmaceutical excipient : sulfobutyl ether-beta-cyclodextrin sodium salt
Name: sulfobutyl ether-beta-cyclodextrin sodium salt
DMF NO.: 030167
Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt
CAS:
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 : USP38 / EP8.0
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum
Use : medical
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
Specification : USP38
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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Keywords
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