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Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
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DMF No.: 030167
Name: Betadex sulfobutyl ether sodium
Other name: Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt;Sulfobutyl ether-β-cyclodextrin sodium salt;
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular formula: C42H70-nO35 (C4H8O3S Na)n
Molecular weight: 1135+158n
Solubility (in 100cm3 solvent, at 25℃) : Water:>50g ; Methanol:<0.5g ; Acetone:<0.5g
Qaulity: Injection grade
Standard: USP43
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum or customized
Use : Medical
Specification:
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Standard
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USP43-NF38
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ITEMS
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CRITERIA
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Appearance
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White to off-white,amorphous powder.
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Solubility
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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.
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Identification
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IR
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Same absorption bands as USP betadex sulfobutyl ether sodium RS.
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HPLC
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The retention time of the major peak of sample solution corresponds to the standard solution.
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Average Degree of Substitution
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Conform
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Sodium
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Identify test are positive for Sodium
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Assay
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95.0%~105.0%
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Beta Cyclodextrin
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≤0.1%
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1,4-Butane Sultone
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≤0.5ppm
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Sodium Chloride
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≤0.2%
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4-Hydroxybutane-1-sulfonic Acid
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≤0.09%
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Bis(4-sulfobtyl) Ether Disodium
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≤0.05%
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Bacterial Endotoxins
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≤20EU/g
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The total aerobic microbial count
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≤100cfu/g
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The total combined moulds and yeasts count
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≤50cfu/g
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Escherichia coli
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Absence
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Clarity of Solution
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30%(w/v) solution is clear and essentially free from particles of foreign matter.
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Average Degree of Substitution
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6.2~6.9
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Peaks I-X
(%peak area)
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I
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0.0~0.3
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II
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0.0~0.9
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III
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0.5~5.0
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IV
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2.0~10.0
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V
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10.0~20.0
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VI
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15.0~25.0
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VII
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20.0~30.0
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VIII
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10.0~25.0
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IX
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2.0~12.0
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X
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0.0~4.0
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pH
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4.0~6.8
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Water content
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≤10.0%
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Packaging and storage
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Preserve in well-closed containers,and store at room temperature. Protect from moisture.
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Features and applications:
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 units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.
If you're looking for the high-quality sulfobutyl ether-beta-cyclodextrin sodium salt, our company must be your best choice. We're one of the leading manufacturers and supplier with rich experience and wide expertise. Please be rest assured to buy the products from our factory. |
Send Inquiry
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Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
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1. Product Name : Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
.......................................................................................................................................................
CAS NO. : 182410-00-0
.......................................................................................................................................................
Synonyms : BETADEX SULFOBUTYL ETHER SODIUM
.......................................................................................................................................................
Molecular Formula : C42H70-nO35 (C4H8O3S Na)n
.......................................................................................................................................................
Molecular Weight : 1135+158n
.......................................................................................................................................................
2. Product Specification of Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
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Standard
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USP41-NF36
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|
ITEMS
|
CRITERIA
|
|
Appearance
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White to off-white,amorphous powder.
|
|
Solubility
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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
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IR
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Same absorption bands as USP betadex sulfobutyl ether sodium RS.
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|
HPLC
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The retention time of the major peak of sample solution corresponds to the standard solution.
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|
Average Degree of Substitution
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Conform
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|
Sodium
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Identify test are positive for Sodium
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|
Assay
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95.0%~105.0%
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Beta Cyclodextrin
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≤0.1%
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1,4-Butane Sultone
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≤0.5ppm
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Sodium Chloride
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≤0.2%
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4-Hydroxybutane-1-sulfonic Acid
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≤0.09%
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Bis(4-sulfobtyl) Ether Disodium
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≤0.05%
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Bacterial Endotoxins
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≤20EU/g
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The total aerobic microbial count
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≤100cfu/g
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|
The total combined moulds and yeasts count
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≤50cfu/g
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Escherichia coli
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Absence
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Clarity of Solution
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30%(w/v) solution is clear and essentially free from particles of foreign matter.
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Average Degree of Substitution
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6.2~6.9
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Peaks I-X
(%peak area)
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I
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0.0~0.3
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II
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0.0~0.9
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III
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0.5~5.0
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IV
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2.0~10.0
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V
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10.0~20.0
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VI
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15.0~25.0
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VII
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20.0~30.0
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VIII
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10.0~25.0
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IX
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2.0~12.0
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X
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0.0~4.0
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pH
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4.0~6.8
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Water content
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≤10.0%
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Packaging and storage
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Preserve in well-closed containers,and store at room temperature. Protect from moisture.
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Send Inquiry
|
|
Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
|
CAS: 182410-00-0
Abbreviation: SBEBCD
Molecular weight: 1135+158n
Standard : USP /EP
Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum
Use: medical
Packaging & Delivery
Packaging Details
Inner Packaging:500g/Bag,1kg/Bag,2kg/Bag,10kg/Bag,20kg/Bag
Outer Packaging:10kg/Drum,20kg/Drum.
Loading Port: Qingdao,Beijing,Shanghai,Tianjin,Dalian Etc. As Your Requirement.
Sulfobutyl ether beta cyclodextrin sodium 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.
|
Send Inquiry
|
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