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Betadex Sulfobutyl Ether Sodium Cas-182410-00-0

Betadex Sulfobutyl Ether Sodium Cas-182410-00-0

1.Product Introduction of BETADEX SULFOBUTYL ETHER SODIUM Sulfobutylether bata cyclodextrin sodium is one of the ramification of beta cyclodextrin,it is used in the medicine as carrier,and it can strongerly improve the solubility of drugs,it has more strong water solubility than any other...

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Product Details

1.Product Introduction of BETADEX SULFOBUTYL ETHER SODIUM

Sulfobutylether bata cyclodextrin sodium is one of the ramification of beta cyclodextrin,it is used in the medicine as carrier,and it can strongerly improve the solubility of drugs,it has more strong water solubility than any other cyclodextrins.

2.Quick Details of BETADEX SULFOBUTYL ETHER SODIUM

Product Name  : Sulfobutyl Ether-β-cyclodextrin Sodium salt

CAS NO.  : 182410-00-0

Synonyms  :Betadex sulfobutyl ether sodium 

DMF No.  : 030167

Abbreviate: SBEBCD

Molecular Formula : C42H70-nO35 (C4H8O3S Na)n

Molecular Weight: 1135+158n


3.Product Specification of BETADEX SULFOBUTYL ETHER SODIUM


Standard  USP39-NF34
ITEMSSPECIFICATION
 Clarity of Solution A 30%w/v solution in water is clear and essentially free from particles of foreign matter
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 Substitution6.2-6.9
Water solution pHpH of 30%w/v solution in water is 4.0-6.8
Heavy Metals≤5ppm
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%
Assay95.0%-105.0%
Bacterial endotoxins≤20EU/g
Microbiology
TAMC ( cfu/g)≤100 cfu/g
TYMC ( cfu/g)≤50 cfu/g
Escherichia ColiAbsence


4.Main detection equipment



Device nameCondition
High Performance Liquid ChromatographyAcceptable
Gas ChromatographAcceptable
Digital pH MeterAcceptable
Digital Conductivity MeterAcceptable
Muffle StoveAcceptable
Electric Blast OvenAcceptable
Constant Temperature Oil BathAcceptable
Micro Moisture MeterAcceptable
Electronic BalanceAcceptable
Heated IncubatorsAcceptable
Colony CountAcceptable
OscillatorAcceptable
Stability Test ChamberAcceptable
IncubatorAcceptable
Biochemical incubatorAcceptable
Mold IncubatorAcceptable
Biological Safety CabinetsAcceptable


5.Main Application:

The use of Sulfobutyl Ether-β-cyclodextrin Sodium salt in the drug is relatively clear, it is mainly used in the anti-cancer drugs such as Voriconazole, posaconazole and Delafloxacin .


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