Product name: Betadex sulfobutyl ether sodium, Injection grade
(β-Cyclodextrin, sulfobutyl ethers, sodium salts)
CAS No.: 182410-00-0
Abbreviation: SBEBCD
Molecular formula: C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Molecular Structure:
Description
Betadex sulfobutyl ether sodium is white to off-white, amorphous powder. Soluble in water, Insoluble in acetone, methanol, chloroform.
Application
Betadex sulfobutyl ether sodium is a new type of pharmaceutical excipient, which belongs to a sulfonic derivative of anionic high water-soluble cyclodextrin. It can be well encapsulated with drug molecules to form non-covalent complexes, which improves the stability, water solubility, safety of the drug and effectively improves the biological activity of the drug molecule. It has low nephrotoxicity and can alleviate drug hemolysis Control the rate of drug release.
Specification
Standard | USP41-NF36 |
Appearance | White to off-white, amorphous powder. |
Solubility | Freely soluble in water, sparingly soluble in methanol, practically insoluble in ethanol, in n-hexane, in 1-butanol, in acetonitrile, in 2-propanol and in ethyl acetate. |
Identification (IR) | Same absorption bands as USP betadex sulfobutyl ether sodium RS. |
Identification (HPLC) | The retention time of the major peak of sample solution corresponds to the standard solution. |
Identification (Average Degree of Substitution) | Conform |
Identification (Sodium) | Identify test are positive for Sodium |
Assay | 95.0%~105.0% |
Beta Cyclodextrin | ≤0.1% |
1,4-Butane Sultone | ≤0.5ppm |
Sodium Chloride | ≤0.2% |
4-Hydroxybutane-1-sulfonic Acid | ≤0.09% |
Bis(4-sulfobtyl) Ether Disodium | ≤0.05% |
Bacterial Endotoxins | ≤20EU/g |
The total aerobic microbial count | ≤100cfu/g |
The total combined moulds and yeasts count | ≤50cfu/g |
Escherichia coli | Absence |
Clarity of Solution | 30%(w/v) solution is clear and essentially free from particles of foreign matter. |
Average Degree of Substitution | 6.2~6.9 |
Peaks I-X (%peak area): | |
I | 0.0~0.3 |
II | 0.0~0.9 |
III | 0.5~5.0 |
IV | 2.0~10.0 |
V | 10.0~20.0 |
VI | 15.0~25.0 |
VII | 20.0~30.0 |
VIII | 10.0~25.0 |
IX | 2.0~12.0 |
X | 0.0~4.0 |
pH | 4.0~6.8 |
Water content | ≤10.0% |
Packing
500g/bag , 1kg/bag , 2kg/bag, 10kg/drum.
Storage
Preserve in well-closed containers, and store at room temperature. Protect from moisture.
