Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
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Name:Betadex sulfobutyl ether sodium DMF No.: 030167 CASNo.: 182410-00-0 Standard:USP40 Qaulity:Injection grade
DMF No.: 030167
Name: Sulfobutyl ether-beta-cyclodextrin sodium salt
Other name : Betadex sulfobutyl ether sodium ; Sulfobutyl ether-β-cyclodextrin sodium salt
CAS No.: 182410-00-0
Abbreviation: SBEBCD
Molecular formula : C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Qaulity:Injection grade
Standard : USP40
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized
Use:medical
Specification : USP40
Standard | USP40-NF35 |
ITEMS | SPECIFICATION |
Appearance | White to off-white solid, free from foreign matter |
Solution Clarity | A 30%w/v solution in water is clear and essentially free from particles of foreign matter |
Identification (IR) | Consistent with SBECD standard |
Identification(Sodium) | Identify test are positive for Sodium |
Identification(LC) | the retention time of the major peak of sample solution corresponds to the standard solution |
Average Degree of Substitution | 6.2-6.9 |
Water solution pH | pH of 30%w/v solution in water is 4.0-6.8 |
Heavy Metals | ≤5ppm |
Water | ≤10% |
β-Cyclodextrin Content | ≤0.1% |
Sodium Chloride | ≤0.2% |
1,4-butane sultone | ≤0.5ppm |
4-Hydroxybutane-1-Sulfonic Acid | ≤0.09% |
Disodium bis-(4-sulfobtyl) ether | ≤0.05% |
Assay | 95%-105% |
Bacterial endotoxins | ≤20EU/g |
Microbiology | |
Total viable aerobic count (mould plus yeast) | ≤100CFU/g |
Escherichia Coli | Absence |
mould plus yeast | ≤50CFU/g |
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.
If you're looking for the high-quality sulfobutyl ether-beta-cyclodextrin sodium salt, our company will be your best choice. We're one of the leading manufacturers and supplier with rich experience and wide expertise. Please be rest assured to buy the products from our factory.
If you're looking for the high-quality sulfobutyl ether-beta-cyclodextrin sodium salt, our company must be your best choice. We're one of the leading manufacturers and supplier with rich experience and wide expertise. Please be rest assured to buy the products from our factory.