Injection Grade Betadex Sulfobutyl Ether Sodium 182410-00-0

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Injection grade betadex sulfobutyl ether sodium
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula :A A C42H70-nO35A A (C4H8O3S Na)nA A
Molecular weight: 1135+158n
Standard : USP39
Package: 500g/bag 1kg/bag 2kg/bag 10kg/drum
Use: medicalA A
Specification : USP39
StandardA A USP39-NF34
ITEMSA A SPECIFICATION
AppearanceWhite to off-white solid free from foreign matter
Solution ClarityA 30%w/v solution in water is clear and essentially free from particles of foreign matter
Identification (IR)Consistent with SBECD standard
Identification(Sodium)Identify test are positive for Sodium
Identification the retention time of the major peak of A A sample solution corresponds to the Standard solution
Average Degree of Substitution6.2-6.9
Water solution pHpH ofA A 30%w/v solution in waterA is 4.0-6.8
Heavy Metals5ppm
Water10%
Cyclodextrin Content0.1%
Sodium Chloride0.2%
14-butane sultone0.5ppm
4-Hydroxybutane-1-Sulfonic Acid0.09%
Disodium bis-(4-sulfobtyl) ether0.05%
Assay95%-105%
Bacterial endotoxins 10EU/g
Microbiology
Total viable aerobic count(mould plus yeast)100CFU/g
Escherichia ColiAbsence
mould plus yeast50CFU/g