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Name: betadex sulfobutyl ether sodium
DMF No: 030167 / Injection grade / USP Standard
Name: Injection grade betadex sulfobutyl ether sodium
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula : C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Standard : USP43
Package: 1kg/bag , 2kg/bag, 10kg/bag, 20kg/bag
Use: Medical
Betadex Sulfobutyl Ether Sodium |
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 |
Product description of betadex sulfobutyl ether sodium:
1.It is an important modified production of Beta-Cyclodextrin.
2.It is mainly used in the azotic medicine as an excipient.
3.It is a new type of anionic high water-soluble cyclodextrin derivatives.
4.It is good at including of drug molecules to form covalent compounds so that improve the stability of drugs, water-solubility, security, reduce renal toxicity, moderate drug hemolytic,control drugs release rate, cover up the bed smell .
5.It has been used for injectable,oral, nasal, eye medication.For Nitrogen drugs has a special affinity and inclusion.
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