Name : Sulfobutyl ether-beta-cyclodextrin sodium salt
Other name : Betadex sulfobutyl ether sodium ; Sulfobutyl ether-β-cyclodextrin sodium salt
CAS No.: 182410-00-0
Abbreviation : SBEBCD
Molecular formula : C42H70-nO35 (C4H8O3S Na)n
Molecular weight : 1135+158n
Qaulity : Injection grade
Standard : USP41
Package : 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum or customized
Use : Medical
Specification :
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▲
Standard
USP42-NF37
ITEMS
CRITERIA
Appearance
White to off-white,amorphous powder.
Solubility
Freely soluble in water,sparingly soluble in methanol,practically insoluble in ethanol, in n-hexane, in 1-butanol, in acetonitrile,in 2-propanol and in ethyl acetate.
Identification
IR
Same absorption bands as USP betadex sulfobutyl ether sodium RS.
HPLC
The retention time of the major peak of sample solution corresponds to the standard solution.
Average Degree of Substitution
Conform
Sodium
Identify test are positive for Sodium
Assay
95.0%~105.0%
Beta Cyclodextrin
≤0.1%
1,4-Butane Sultone
≤0.5ppm
Sodium Chloride
≤0.2%
4-Hydroxybutane-1-sulfonic Acid
≤0.09%
Bis(4-sulfobtyl) Ether Disodium
≤0.05%
Bacterial Endotoxins
≤20EU/g
The total aerobic microbial count
≤100cfu/g
The total combined moulds and yeasts count
≤50cfu/g
Escherichia coli
Absence
Clarity of Solution
30%(w/v) solution is clear and essentially free from particles of foreign matter.
Average Degree of Substitution
6.2~6.9
Peaks I-X
(%peak area)
I
0.0~0.3
II
0.0~0.9
III
0.5~5.0
IV
2.0~10.0
V
10.0~20.0
VI
15.0~25.0
VII
20.0~30.0
VIII
10.0~25.0
IX
2.0~12.0
X
0.0~4.0
pH
4.0~6.8
Water content
≤10.0%
Packaging and storage
Preserve in well-closed containers,and store at room temperature. Protect from moistur
Features and applications:
Sulfobutyl ether-beta-cyclodextrin sodium salt 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.
Sulfobutyl ether-beta-cyclodextrin sodium salt has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.
Product performance:
1. Solubility:
Neutral, positive and negative APIs can be effectively combined with betadex sulfobutyl ether sodium to increase the solubility of the compound by 10 to 25,000 times.
2. Facilitate the drug
Betadex sulfobutyl ether sodium has a good biocompatibility and can be administered by injection, oral, ocular, nasal, topical and inhalation.
3. Good security
In general, it can be quickly and completely removed from the kidneys after administration. In vitro experiments and in vivo acute, subacute and chronic toxicity studies provide safe data and approval for use with pharmaceutical preparations.
4. Good stability
The interaction with sulfobutyricotriacodextrin provides a beneficial protective environment for the drug substance in its lipophilic chamber, while the hydrophilic surface provides excellent water solubility to provide solubility and stability.
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Now we have Ion chromatograph (IC), Capillary electrophoresis (CE), High performance liquid chromatograph (HPLC), Gas chromatograph (GC), Fourier transform infrared spectroscopy (FTIR) and other imported advanced testing equipments. Multiple means of analysis and inspection help us ensure production quality and accelerate new production developing.
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