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

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

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Product Details


Product name:            Betadex sulfobutyl ether sodium, Injection grade

                                     (β-Cyclodextrin, sulfobutyl ethers, sodium salts)

CAS No.:                      182410-00-0

Abbreviation:               SBEBCD

Molecular formula:     C42H70-nO35 (C4H8O3S Na)n

Molecular weight:       1135+158n

Molecular Structure:    

Betadex sulfobutyl ether sodium

Description

Betadex sulfobutyl ether sodium is white to off-white, amorphous powder. Soluble in water, Insoluble in acetone, methanol, chloroform.


Application

Betadex sulfobutyl ether sodium is a new type of pharmaceutical excipient, which belongs to a sulfonic derivative of anionic high water-soluble cyclodextrin. It can be well encapsulated with drug molecules to form non-covalent complexes, which improves the stability, water solubility, safety of the drug and effectively improves the biological activity of the drug molecule. It has low nephrotoxicity and can alleviate drug hemolysis Control the rate of drug release.


Specification

Standard

USP41-NF36

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.

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%

Packing          

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

Storage  

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


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