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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