DMF No.: 030167
Name: sulfobutyl ether-beta-cyclodextrin sodium salt
Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula : C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Qaulity ： injection grade / oral grade
Standard : USP39
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized
Use : medical
Specification : USP39
ITEMS
SPECIFICATION
RESULTS
Appearance
White to off-white solid, free from foreign matter
Qualify
Solution Clarity
A 30%w/v solution in water is clear and essentially free from particles of foreign matter
Qualify
Identification (IR)
Consistent with SBECD standard
Qualify
Sodium Identification
Identify test are positive for Sodium
+
Average Degree of Substitution
6.2-6.9
6.7
SBE 1 Content
≤0.2%
0.05%
SBE 2 Content
≤0.8%
0.15%
Water solution pH
pH of 30%w/v solution in water is 4.0-6.8
5.4
Heavy Metals
≤5ppm
