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: C₄₂H_70-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

9. Product & Packaging Photos:

10. Use: Medical

11. 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.