| CAS No.: | 182410-00-0 |
|---|---|
| Formula: | Betadex Sulfobutyl Ether Sodium |
| EINECS: | 194615-04-8 |
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Test Items | USP Standard |
Clarity of Solution | A 30%w/v solution in water is clear |
Identification (IR) | Same absorption bands as USP betadex sulfobutyl ether sodium RS |
Identification(Sodium) | Identify test are positive for Sodium |
Identification(LC) | the retention time of the major peak of sample solution corresponds to the standard solution |
Average Degree of Substitution | 6.2-6.9 |
Water solution pH | pH of 30%w/v solution in water is 4.0-6.8 |
Water content | ≤10.0% |
β-Cyclodextrin Content | ≤0.1% |
Sodium Chloride | ≤0.2% |
1,4-butane sultone | ≤0.5ppm |
4-Hydroxybutane-1-Sulfonic Acid | ≤0.09% |
Disodium bis-(4-sulfobtyl) ether | ≤0.05% |
Assay | 95.0%-105.0% |
Bacterial endotoxins | ≤20EU/g |
Microbiology | |
TAMC ( cfu/g) | ≤100 cfu/g |
TYMC ( cfu/g) | ≤50 cfu/g |
Escherichia Coli | Absence |
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