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Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
Add:Boxing Economic Development Zone, Binzhou, Shandong, China
Tel:+86-543-2616568
Fax:+86-543-2605568
E-mail: market@cydextrin.com


Sulfobutyl Ether Beta Cyclodextrin sodium salt

Sulfobutyl Ether Beta Cyclodextrin sodium salt

Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt 1.DMF No.: 030167; 2.ISO9001 certificate ; 3.standard :USP40-NF35 4. Grade : injection grade

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Product Details

we are the largest manufacture specialized in excipient : Sulfobutyl Ether-Beta-Cyclodextrin sodium salt in china .we can provide cyclodextrin and cyclodextrin derivatives . we cooperate with many pharmaceutical manfacture in the world .such as Pfizer /Teva etc. If you want to research and development new drug or Generic drug ,please send me email for the details .

Instrument:

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Cleaning room :

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Warehouse :

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Quality center :

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 Information:

DMF: 030167

CAS NO.           : 182410-00-0

Molecular Formula   : C42H70-nO35 (C4H8O3S Na)n

Molecular Weight    : 1135+158n

molecular diagram:

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This Sulfobutyl Ether-Beta-Cyclodextrin is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.

 

 Specification :

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

Application :

  •  Improve the stability of the drug, water solubility, safety

  •  Reduce renal toxicity, ease drug hemolysis

  •  Control the drug release rate

  • cover the bad smell 

Packing :

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


certificate :

  ISO9001-英文.jpgDMF of SBEBCD.png

 

 

 

 

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