Betadex Sulfobutyl Ether Sodium ( EP10.0)
- 來源: 西安德立生物化工有限公司 作者: admin 時間: 2022/11/11 14:31:44 點擊率: 166
- 關(guān)鍵詞: Betadex Sulfobutyl Ether Sodium ( EP10.0)
- 摘要: Betadex Sulfobutyl Ether Sodium is a sodium salt produced when betacyclodextrin is alkylated by 1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble betacyclodextrin derivative.
Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is
alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an
anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium
can bewell combined with the drugmolecules to form non-covalent
therebyenhancingthe stability, water solubility, and safety of the
drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease
rate, covering bad smell, etc.
Betadex Sulfobutyl Ether Sodium
[CAS NO]: 128410-00-0
DMF 034773
[Molecular formula]: C42H70-nO35·(C4H8SO3Na)n
[Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.
[Category]: Pharmaceutical excipients
[Storage]: Seal preservation.
[Period of validity]: 36 months
| Betadex Sulfobutyl Ether Sodium ( EP10.0) | |
| 【CONTENT】 | |
| Sulfobutyl Betadex Sodium | 95.0%-105.0% |
| Average Degree of Substitution | 5.9-6.6 |
| 【CHARACTERS】 | |
| Aooearancce | white or almost white, hygroscopic powder |
| Solubility | freely soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride |
| 【IDENTIFICATION】 | |
| A Infraed Absorption Spectrophotometry |
Complies with SBECD referance |
| B Sodium Reaction |
Positive test for sodium |
| 【TEST】 | |
| PH | 5.0-7.5 |
| Appearance of Solution |
The solution is clear and colourless |
| Reducing Sugars | NMT 0.05% |
| 【IMPURITIES】 | |
| Limit of betadex | NMT 0.1% |
| Limit of 1'2λ6-oxathiane-2,2-dione | NMT 0. 5ppm |
| Limit of 4-hydroxybutane-1-sulfonic acid | NMT 0. 1% |
| Limit of 4,4'-oxydi(butane-1-sulfonic acid) | NMT 0. 05% |
| Limit of soudiun chloride | NMT 0.12% |
| Water | NMT10.0% |
| 【MICROBIAL CONTAMINATION】 | |
| the total aerobic microbial count | NMT 100cfu/g |
| the total combined molds and yeasts count | NMT 100cfu/g |
| Escherichia coli. | absence |
| Salmonella | absence |