Betadex Sulfobutyl Ether Sodium (USP)
- 來源: 西安德立生物化工有限公司 作者: admin 時間: 2022/11/11 14:31:10 點擊率: 103
- 關鍵詞: Betadex Sulfobutyl Ether Sodium (USP)
- 摘要: etadex 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 can be well combined with the drug molecules to form non-covalent complex, thereby enhancing the stability, water solubility, and safety of the drug, reducing its renal toxicity, easing drug hemolysis, controlling drug release rate, covering bad smell, etc.
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Betadex Sulfobutyl Ether Sodium |
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.
[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 (USP-NF2021, Issue 1) | |
|
ASSAY |
SPECIFICATION |
|
【IDENTIFICATION】 |
|
|
A |
Complies with SBECD reference |
|
B |
tR of the major peak complies with SBECD reference |
|
C |
meets the requirements of the test for Average Degree of Substitution. |
|
D |
Positive test for sodium |
|
【ASSAY】 |
|
|
The Percentage of Betadex SulfobutylL Ether Sodium |
95.0%-105.0% on the anhydrous basis |
|
【IMPURITIES】 |
|
|
limit of Beta Cyclodextrin |
NMT 0.1% |
|
limit of 1,4-Butane Sultone |
NMT 0.5ppm |
|
limit of Sodium chloride |
NMT 0.2% |
|
limit of 4-Hydroxybutane-1-sulfonic acid |
NMT 0.09% |
|
limit of Bis(4-sulfobutyl) ether disodium |
NMT 0.05% |
|
Bacterial Endotoxins Test |
≤10EU/g |
|
Microbial Enumeration Tests |
|
|
The total aerobic microbial count |
NMT 100cfu/g |
|
The total combined molds and yeasts count |
NMT 50cfu/g |
|
Tests for Specified Microorganisms |
Absence of Escherichia Coli/1g |
|
Clarity of Solution(30%,w/v) |
The solution is clear, and essentially free from particles of foreign matter |
|
Average Degree of Substitution |
6.2-6.9 |
|
Ether Sodium Peaks I-X |
Limit Range(%Peak Area) |
|
I |
0-0.3 |
|
II |
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 |
0-4.0 |
|
pH |
4.0-6.8 |
|
Water Determination |
NMT 10% |