
1. Product Name : Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
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CAS NO. : 182410-00-0
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Synonyms : BETADEX SULFOBUTYL ETHER SODIUM
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Molecular Formula : C42H70-nO35 (C4H8O3S Na)n
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Molecular Weight : 1135+158n
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2. Product Specification of Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
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Standard |
USP41-NF36 |
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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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