Shandong Binzhou Zhiyuan Bio-tech Co., Ltd.
We are professional supplier of hydroxypropyl cyclodextrin,sulfobutyl ether-beta-cyclodextrin sodium salt,methyl cyclodextrin,mercapto cyclodextrin,amino cyclodextrin,ethanediamine cyclodextrin,piroxi
Business Type:Manufacturer
Country/Region:China
Ddu Verified
HOT Rank
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
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 | ≤20EU/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:
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.
Product performance
1, Solubility:
Neutral, positive and negative APIs can be effectively combined with betadex sulfobutyl ether sodium to increase the solubility of the compound by 10 to 25,000 times.
2, Facilitate the drug
Betadex sulfobutyl ether sodium has a good biocompatibility and can be administered by injection, oral, ocular, nasal, topical and inhalation.
3, Good security
In general, it can be quickly and completely removed from the kidneys after administration. In vitro experiments and in vivo acute, subacute and chronic toxicity studies provide safe data and approval for use with pharmaceutical preparations.
4, Good stability
The interaction with sulfobutyricotriacodextrin provides a beneficial protective environment for the drug substance in its lipophilic chamber, while the hydrophilic surface provides excellent water solubility to provide solubility and stability.
