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Category:Excipients > Wetting/Solubilizing Agents
Product Name:Betadex Sulfobutyl Ether Sodium From Binzhou Zhiyuan Cas 182410-00-0
CAS No.:182410-00-0
Standard:ChP, USP, EP
Price(USD):Negotiable
Company:Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
Grade: Injection Grade
Factory Location: Shandong China
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Sample Provided: yes
Payment Terms: L/L
DMF No.: 030167
Name: Betadex sulfobutyl ether sodium
Other name: Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt;Sulfobutyl ether-β-cyclodextrin sodium salt;
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula: C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Solubility (in 100cm3 solvent, at 25℃) : Water:>50g ; Methanol:<0.5g ; Acetone:<0.5g
Qaulity: Injection grade
Standard: USP43
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum or customized
Use : Medical
Specification:
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Standard |
USP43-NF38 |
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ITEMS |
CRITERIA |
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Appearance |
White to off-white,amorphous powder. |
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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. |
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Identification |
IR |
Same absorption bands as USP betadex sulfobutyl ether sodium RS. |
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HPLC |
The retention time of the major peak of sample solution corresponds to the standard solution. |
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Average Degree of Substitution |
Conform |
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Sodium |
Identify test are positive for Sodium |
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Assay |
95.0%~105.0% |
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Beta Cyclodextrin |
≤0.1% |
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1,4-Butane Sultone |
≤0.5ppm |
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Sodium Chloride |
≤0.2% |
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4-Hydroxybutane-1-sulfonic Acid |
≤0.09% |
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Bis(4-sulfobtyl) Ether Disodium |
≤0.05% |
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Bacterial Endotoxins |
≤20EU/g |
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The total aerobic microbial count |
≤100cfu/g |
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The total combined moulds and yeasts count |
≤50cfu/g |
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Escherichia coli |
Absence |
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Clarity of Solution |
30%(w/v) solution is clear and essentially free from particles of foreign matter. |
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Average Degree of Substitution |
6.2~6.9 |
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Peaks I-X (%peak area) |
I |
0.0~0.3 |
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II |
0.0~0.9 |
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III |
0.5~5.0 |
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IV |
2.0~10.0 |
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V |
10.0~20.0 |
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VI |
15.0~25.0 |
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VII |
20.0~30.0 |
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VIII |
10.0~25.0 |
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IX |
2.0~12.0 |
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X |
0.0~4.0 |
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pH |
4.0~6.8 |
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Water content |
≤10.0% |
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Packaging and storage |
Preserve in well-closed containers,and store at room temperature. Protect from moisture. |
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Features and applications:
SBE-β-CD is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.
SBE-β-CD has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.
If you're looking for the high-quality sulfobutyl ether-beta-cyclodextrin sodium salt, our company must be your best choice. We're one of the leading manufacturers and supplier with rich experience and wide expertise. Please be rest assured to buy the products from our factory.
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