Sulfobutylated Beta-cyclodextrin Sodium
Sodium sulfobutylated β-cyclodextrin is a kind of anionic and highly water-soluble β-CD derivative. It can well form non-covalent complexes with drug molecules by inclusion, thereby improving the stability, water solubility, safety of drugs, reducing nephrotoxicity, alleviating hemolytic effect of drugs, controlling the release rate of drugs, and masking unpleasant odors, etc. Compared with β-CD, it has better water solubility, less hemolytic effect and lower nephrotoxicity, and is a new type of drug excipient with very broad application prospects.
Basic Information
|
Product Name |
Sodium Sulfobutyl Beta-Cyclodextrin |
|
Quality Standards |
USP-NF 2023, EP 10.3, Enterprise Standard |
|
Appearance and Shape |
White Powder |
|
CAS No. |
182410-00-0 |
|
Molecular Formula |
C42H70-nO35(C4H8SO3Na)n, where n represents the degree of substitution |
|
Molecular Weight |
1134 + 158n |
Product Features
Sodium sulfobutylated beta-cyclodextrin is also known as sulfobutyl ether beta-cyclodextrin sodium salt. It is a sodium salt formed by beta-cyclodextrin being alkylated with 1,4-butanedisulfonic acid ester under alkaline conditions. It is an anionic type highly water-soluble cyclodextrin derivative. It can well form non-covalent complexes with drug molecules to encapsulate drugs, thereby improving the stability, water solubility, safety, reducing nephrotoxicity, alleviating hemolytic toxicity of drugs, controlling the release rate of drugs, masking unpleasant odors, etc.
Administration route: Intravenous injection, oral administration, nasal administration, ocular administration. It has a special affinity and inclusion capacity for nitrogen-containing drugs.
Product Performance
Solubilization
Neutral, cationic and anionic raw materials can effectively combine with sulfobutyl beta-cyclodextrin, thereby increasing the solubility of compounds with different solubilities in raw material solutions by 10 to 25,000 times.
01
Convenient administration
Sulfobutyl beta-cyclodextrin has excellent biocompatibility and can be administered by injection, oral administration, eye, nasal, topical and inhalation.
02
Good safety
Under normal circumstances, it can be rapidly and completely eliminated from the kidneys after administration. Safety data from in vitro experiments and acute, subacute and chronic toxicity studies in vivo have been provided and it has been approved for use in human pharmaceutical preparations.
03
Good stability
The interaction with sulfobutyl beta-cyclodextrin can provide a beneficial protective environment for raw materials in its lipophilic cavity, while the hydrophilic surface provides excellent water solubility for solubility and stability.
04
Test Standard
|
Test items |
USP-NF2024 |
Ph. Eur |
|||
|
Properties |
White or off-white amorphous powder |
White or off-white hygroscopic powder |
|||
|
Solubility |
This product is easily soluble in water, slightly soluble in methanol, and almost insoluble in ethanol, n-hexane, n-butane, acetonitrile, isopropanol and ethyl acetate |
Easily soluble in water, almost insoluble in anhydrous ethanol and dichloromethane |
|||
|
Identification |
Infrared spectrum |
The sample solution should have the same absorption band as the standard solution |
Infrared spectroscopy |
Shows the same absorption band as the standard |
|
|
Liquid phase |
The retention time of the main peak of the sample solution should be consistent with the retention time of the standard solution |
||||
|
Average degree of substitution |
Should comply with regulations |
Sodium |
Reacts as a sodium salt |
||
|
Sodium |
React as a sodium salt |
||||
|
Content |
95.0%~105.0% |
95.0%~105.0% |
|||
|
pH of aqueous solution |
30% w/v aqueous solution pH 4.0-6.8 |
5.0~7.5 |
|||
|
Heavy metals |
≤5ppm |
N/A |
|||
|
Beta-cyclodextrin |
≤0.1% |
≤0.1% |
|||
|
1,4-butane sultone |
≤0.5ppm |
≤0.5ppm |
|||
|
Sodium chloride |
≤0.2% |
≤0.12%(Chloride, equivalent to 0.20% sodium chloride) |
|||
|
4-hydroxybutane-1-sulfonic acid |
≤0.09% |
≤0.1% |
|||
|
Disodium bis(4-sulfobutyl) ether |
≤0.05% |
≤0.05% |
|||
|
Bacterial endotoxins |
≤10Eu/g |
N/A |
|||
|
Total number of aerobic bacteria |
≤100cfu/g |
≤100 cfu/g (parenteral preparations) ≤1000 cfu/g (non-parenteral preparations) |
|||
|
Total number of molds and yeasts |
≤50cfu/g |
≤1000 cfu/g (non-parenteral preparations) |
|||
|
Escherichia coli |
Not detectable |
Not detectable | |||
|
Salmonella |
N/A |
Not detectable |
|||
|
Solution clarity |
30%(W/V)Solution clarification |
Clear and colorless | |||
|
Average degree of substitution |
6.2~6.9 |
5.9~6.6 |
|||
|
Peak (% peak area) |
I |
0-0.3 |
N/A |
||
|
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 |
||||
|
Water |
≤10.0% |
≤10.0% |
|||
|
Reducing sugar |
N/A |
≤0.05% |
|||
Packaging and Storage
- Packaging: In line with pharmaceutical packaging
- Packaging Specifications: 1 kilogram per bag; 2 kilograms per bag; 10 kilograms per barrel; 20 kilograms per barrel
- Storage: Sealed and stored in a dry place
Hot Tags: betadex sulfobutyl ether sodium, China betadex sulfobutyl ether sodium manufacturers, suppliers, factory, 94035-02-6, Hydroxypropyl-Beta-Cyclodextrin (Oral Pharmaceutical Grade), Hydroxypropyl-Gamma-Cyclodextrin, 128446-34-4, pharmaceutical cyclodextrin, Hydroxypropyl Beta Cyclodextrin For Injection
