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Betadex Sulfobutyl Ether Sodium

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Item Details

Product Description

Name: Betadex sulfobutyl ether sodium

CAS NO. : 182410-00-0

DMF No.: 030167

Sulfobutyl Ether-ß-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.

 

Molecular Formula:C42H70-nO35 (C4H8O3S Na)n

Molecular Weight :  1135+158n

 Product Specification of Sulfobutyl Ether-ß-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

Identification(LC)

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%

ß-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

 

 

Primary Competitive Advantages:

  Packing Detail       : 500g/bag, 1kg/bag, 2kg/bag, 10kg/drum, 20kg/drum or other quantity just as you requests.

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Occasionally, we are out of stock of an item ordered within 3-10 working days.

 If we are not going to be able to dispatch the item within 3 days we will contact you to advise on the situation. Should you wish to change the order you can do so at that time.

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