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Food;Pharmaceutical Additives

Sulfobutyl Ether Beta Cyclodextrin

Product Name: sulfobutyl ether-beta-cyclodextrin sodium salt  

Other name : betadex sulfobutyl ether sodium ; sulfobutyl ether-β-cyclodextrin sodium salt 

CAS: 182410-00-0

Abbreviation: SBEBCD

Molecular formula : C42H70-nO35 (C4H8O3S Na)n 

Molecular weight: 1135+158n

Quality: injection grade / oral grade

Standard : USP40

Package: 500g/bag , 1kg/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized


Specification

ITEMSSPECIFICATIONRESULTS
AppearanceWhite to off-white solid, free from foreign matterQualify
Solution ClarityA 30%w/v solution in water is clear and essentially free from particles of foreign matterQualify
Identification (IR)Consistent with SBECD standardQualify
Sodium IdentificationIdentify test are positive for Sodium+
Average Degree of Substitution6.2-6.96.7
SBE 1 Content≤0.2%0.05%
SBE 2 Content≤0.8%0.15%
Water solution pHpH of 30%w/v solution in water is 4.0-6.85.4
Heavy Metals≤5ppm<5ppm
Water≤10%4.0%
β-Cyclodextrin Content≤0.1%Absence
Sodium Chloride≤0.2%0.01%
1,4-butane sultone≤0.5ppm0.3ppm
4-Hydroxybutane-1-Sulfonic Acid≤0.09%0.01%
Disodium bis-(4-sulfobtyl) ether≤0.05%0.05%
Assay95%-105%99.5%
Bacterial endotoxins≤25EU/g≤20EU/g
Microbiology
Total viable aerobic count (mould plus yeast)≤100CFU/g20CFU/g
Escherichia ColiAbsenceAbsence
Salmonella speciesAbsenceAbsence
mould plus yeast≤50CFU/gAbsence


Application

Sulfobutyl ether beta cyclodextrin sodium is a new type of anionic high soluble cyclodextrin derivatives. It could include drug molecules to from covalent compounds so that increase the drug’s stability,solubility,safety.

It could reduce the renal toxicity,moderate drug’s hemolysis,control the release rate and cover up the bad smell. 

It can be used as a solubilizer,wetting agent,chelating agent (complexing agent) and polyvatent masking agent.

It has been used in injection,oral,nasal and eye medicines.It could has a special affinity and inclusion for nitrogen drugs


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