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DMF No.: *****7
Name: sulfobutyl ether-beta-cyclodextrin sodium salt
Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt
CAS NO.: **********0
Abbreviation: SBEBCD
Molecular formula : C*2H**-nO*5 (C4H8O3S Na)n
Molecular weight: ***5***8n
Qaulity ： injection grade / oral grade
Standard : USP*9 / EP9.0
Package: **0g/bag , 1kg/bag , 2kg/bag, *0kg/drum , *0kg/drum or customized
Use : medical
Specification : USP*9
|
ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
White to off-white solid, free from foreign matter |
Qualify |
|
Solution Clarity |
A *0%w/v solution in water is clear and essentially free from particles of foreign matter |
Qualify |
|
Identification (IR) |
Consistent with SBECD standard |
Qualify |
|
Sodium Identification |
Identify test are positive for Sodium |
+ |
|
Average Degree of Substitution |
6.**6.9 |
6.7 |
|
SBE 1 Content |
≤0.2% |
0.*5% |
|
SBE 2 Content |
≤0.8% |
0.*5% |
|
Water solution pH |
pH of *0%w/v solution in water is 4.**6.8 |
5.4 |
|
Heavy Metals |
≤5ppm |
<5ppm |
|
Water |
≤*0% |
4.0% |
|
β-Cyclodextrin Content |
≤0.1% |
Absence |
|
Sodium Chloride |
≤0.2% |
0.*1% |
|
1,*-butane sultone |
≤0.5ppm |
0.3ppm |
|
*-Hydroxybutane**-Sulfonic Acid |
≤0.*9% |
0.*1% |
|
Disodium bis-(*-sulfobtyl) ether |
≤0.*5% |
0.*5% |
|
Assay |
*5%***5% |
*9.5% |
|
Bacterial endotoxins |
≤*5EU/g |
≤*0EU/g |
|
Microbiology |
||
|
Total viable aerobic count (mould plus yeast) |
≤**0CFU/g |
*0CFU/g |
|
Escherichia Coli |
Absence |
Absence |
|
Salmonella species |
Absence |
Absence |
|
mould plus yeast |
≤*0CFU/g |
Absence |
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.
| Country: | China |
| Model No: | - |
| FOB Price: | Get Latest Price |
| Place of Origin: | - |
| Price for Minimum Order: | - |
| Minimum Order Quantity: | - |
| Packaging Detail: | - |
| Delivery Time: | - |
| Supplying Ability: | - |
| Payment Type: | - |
| Product Group : | - |
