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1 Kilogram |
Negotiable |
Sulfobutyl Ether-beta-cyclodextrin Cyclodextrin 182410-00-0
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 unitscan improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.
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 |
<5ppm |
Water |
≤10% |
4.0% |
β-Cyclodextrin Content |
≤0.1% |
Absence |
Sodium Chloride |
≤0.2% |
0.01% |
1,4-butane sultone |
≤0.5ppm |
0.3ppm |
4-Hydroxybutane-1-Sulfonic Acid |
≤0.09% |
0.01% |
Disodium bis-(4-sulfobtyl) ether |
≤0.05% |
0.05% |
Assay |
95%-105% |
99.5% |
Bacterial endotoxins |
≤20EU/g |
≤20EU/g |
Microbiology |
||
Total viable aerobic count (mould plus yeast) |
≤100CFU/g |
20CFU/g |
Escherichia Coli |
Absence |
Absence |
Salmonella species |
Absence |
Absence |
mould plus yeast |
≤50CFU/g |
Absence |
CAS NO:160661-60-9
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