1. Product Name: BETADEX SULFOBUTYL ETHER SODIUM
2. Other Name: Sulfobutyl ether-beta-cyclodextrin sodium salt; Sulfobutyl Ether-β-cyclodextrin
3. CAS No.: 182410-00-0
4. Abbreviation: SBECD; SBE-β-CD
5. Molecular Formula: C42H70-nO35 (C4H8O3S Na)n
6. Molecular Weight: 1135+158n
7. Standard: USP-NF2021
8. Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum, 20kg/drum
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9. Specifications:
Appearance: White to off-white, amorphous powder
Solubility: Very 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.
Identification:
IR: Same absorption bands as USP betadex sulfobutyl ether sodium RS.
HPLC: The retention time of the major peak of sample solution corresponds to the standard solution.
Average Degree of Substitution: Conform
Sodium: Identify test are positive for Sodium.
Assay: 95.0%~105.0%
Beta Cyclodextrin: ≤0.1%
1,4-Butane Sultone: ≤0.5ppm
Sodium Chloride: ≤0.2%
4-Hydroxybutane-1-sulfonic Acid: ≤0.09%
Bis(4-sulfobtyl) Ether Disodium: ≤0.05%
Bacterial Endotoxins: ≤20EU/g
The total aerobic microbial count: ≤100cfu/g
The total combined moulds and yeasts count: ≤50cfu/g
Escherichia coli: Absence
Clarity of Solution: 30%(w/v) solution is clear and essentially free from particles of foreign matter.
Average Degree of Substitution: 6.2-6.9
Peaks I-X(% peak area):
Ⅰ: 0.0~0.3
Ⅱ: 0.0~0.9
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: 0.0~4.0
pH: 4.0~6.8
Water content: ≤10.0%
Storage: Preserve in well-closed containers, and store at room temperature. Protect from moisture.
