Sulfobutyl ether beta cyclodextrin

Abbreviation

SBECD

CAS No:

182410-00-0

Synonym:

Sulfobutylether-beta-Cyclodextrin,Sulfobutylether-β-Cyclodextrin   

Molecular formula:

C42H70-nO35(C4H8O3SNa)n    

Standard:                                             

USP43-NF38

Quality:

Injection grade 

DMF No:

030167 

 Appearance:

White or almost white amorphous powder

Solubility:

Very 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 salt RS

HPLC

The retention time of the major peak of same solution corresponds

to the standard solution.

Average degree of

substitution

Confirm.

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-sulfobutyl) 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.

PH

4.0~6.8

Water content

≤10.0%

Storage

Preserve in well-closed containers,Store at room

temperature.Protect from moisture.