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Betadex Sulfobutyl Ether Sodium 182410-00-0 Injection Grade
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Betadex Sulfobutyl Ether Sodium 182410-00-0 Injection Grade

Sulfobutyl ether beta cyclodextrin sodium is a high water-soluble anionic cyclodextrin derivative. Freely 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.
  • SBECD
  • 182410-00-0

Betadex sulfobutyl ether sodium

CAS No.:182410-00-0 Injection grade 

 

Product Introduction

Sulfobutyl ether beta cyclodextrin sodium 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.

 

Quick Details

Product Name

Sulfobutyl ether beta cyclodextrin sodium

CAS No.

182410-00-0

Other Names

SBECD

Molecular Formula 

 C42H70-nO35 (C4H8O3S Na)n

Molecular Weight 

 1135+158n

 

Product Specification

ITEMS

criteria

Appearance

White to off-white,amorphous powder. 

Solubility

Freely 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 RS.

Identification (HPLC)

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

Identification (Average Degree of Substitution)

Conform

Identification (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-sulfobtyl) 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.

ITEMS

criteria

Average Degree of Substitution

6.2~6.9

Peaks I-X

(% peak area)

I

0.0~0.3

II

0.0~0.9

III

0.5~5.0

IV

2.0~10.0

V

10.0~20.0

VI

15.0~25.0

VII

20.0~30.0

VIII

10.0~25.0

IX

2.0~12.0

X

0.0~4.0

pH

4.0~6.8

Water content

≤10.0%

Packaging and storage

Preserve in well-closed containers,and store at room temperature. Protect from moisture.

Conclusion: Compliant to the USP43-NF38

 

Application of SBECD

Sulfobutyl ether beta cyclodextrin sodium is a new type of anionic high soluble cyclodextrin derivatives, which can be used as a solubilizer, wetting agent, chelating agent (complexing agent) and polyvatent masking agent. 

It has been used in injection, oral, nasal and eye medicines. It has a special affinity and inclusion for nitrogen drugs. 

Increase the drug's stability ,solubility ,safety (Include drug molecules to form non-covalent) .Reduce renal toxicity, ease drug hemolysis.Control the drug release rate, cover the bad smell.

 

Packaging & Delivery

Packaging Details: 10kg/drum


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 Mail: enquiry@cydextrin.com
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