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Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
Add:Boxing Economic Development Zone, Binzhou, Shandong, China
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Betadex Sulfobutyl Ether Sodium From Binzhou

Betadex Sulfobutyl Ether Sodium From Binzhou

Injection grade betadex sulfobutyl ether sodium

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Product Details

Name: Injection grade betadex sulfobutyl ether sodium  

CAS: 182410-00-0

Abbreviation: SBEBCD

Molecular formula : C42H70-nO35 (C4H8O3S Na)n 

Molecular weight: 1135+158n

Standard : USP39

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

Use: medical 

Specification : USP39


Standard

 USP39-NF34

ITEMS

SPECIFICATION

Appearance

White to off-white solid, free from foreign matter

Solution Clarity

A 30%w/v solution in water is clear and essentially free from particles of foreign matter

Identification (IR)

Consistent with SBECD standard

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

≤10%

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%-105%

Bacterial endotoxins

≤20EU/g

Microbiology

Total viable aerobic count (mould plus yeast)

≤100CFU/g

Escherichia Coli

Absence

mould plus yeast

≤50CFU/g


 

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