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182410-00-0

182410-00-0

Name: Sulfobutyl Ether-β-cyclodextrin Sodium salt Item No.: BZZY-006 CAS NO. : 182410-00-0 DMF No.: 030167 Sulfobutyl Ether-β-cyclodextrin Sodium salt has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of...

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Product Details

 

Name: Sulfobutyl Ether-β-cyclodextrin Sodium salt

Item No.: BZZY-006

CAS NO. : 182410-00-0

DMF No.: 030167

Sulfobutyl Ether-β-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.

 

Product Details

Product name: Sulfobutyl Ether-β-cyclodextrin Sodium salt

Synonyms : Betadex sulfobutyl ether sodium

               Sulfobutyl -β-cyclodextrin

Sulfobutyl beta cyclodextrin

Shape:white power

Molecular Formula:C42H70-nO35 (C4H8O3S Na)n

Molecular Weight :  1135+158n

 Product Specification of Sulfobutyl Ether-β-cyclodextrin Sodium salt

Standard

 USP40-NF35

ITEMS

SPECIFICATION

 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

IdentificationLC

the retention time of the major peak of  sample solution corresponds to the  standard solution

Average Degree of Substitution

6.2-6.9

Water solution pH

pH 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%

Assay

95.0%-105.0%

Bacterial endotoxins

≤20EU/g

Microbiology

TAMC ( cfu/g)

≤100 cfu/g

TYMC ( cfu/g)

≤50 cfu/g

Escherichia Coli

Absence

 

 

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