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: 111
- 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.
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% |