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Product 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
Quality: injection grade / oral grade
Standard : USP40
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized
Specification
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 |
Application
Sulfobutyl ether beta cyclodextrin sodium is a new type of anionic high soluble cyclodextrin derivatives. It could include drug molecules to from covalent compounds so that increase the drug’s stability,solubility,safety.
It could reduce the renal toxicity,moderate drug’s hemolysis,control the release rate and cover up the bad smell.
It can be used as a solubilizer,wetting agent,chelating agent (complexing agent) and polyvatent masking agent.
It has been used in injection,oral,nasal and eye medicines.It could has a special affinity and inclusion for nitrogen drugs
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