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Betadex Sulfobutyl Ether Sodium

Betadex Sulfobutyl Ether Sodium

Name: Betadex Sulfobutyl Ether Sodium CAS: 182410-00-0 Molecular formula: C 42 H 70-n O 35 (C 4 H 8 O 3 S Na)n Molecular weight: 1135+158n Quality: Injection grade Standard: USP40 Package: 500g/bag,1kg/bag,10kg/drum or customized The role in ophthalmic medicine Betadex sulfobutyl ether sodium...

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Product Details

Name: Betadex Sulfobutyl Ether Sodium

CAS: 182410-00-0

Molecular formula: C42H70-nO35(C4H8O3S Na)n

Molecular weight: 1135+158n

Quality: Injection grade

Standard: USP40

Package: 500g/bag,1kg/bag,10kg/drum or customized

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

SBE 1 Content

0-0.3

SBE IIContent

0-0.9

SBE III Content

0.5-5.0

SBE IV Content

2.0-10.0

SBE V Content

10.0-20.0

SBE VIContent

15.0-25.0

SBE VIIContent

20.0-30.0

SBE VIII Content

10.0-25.0

SBE IXContent

2.0-12.0

SBE XContent

0-4.0

Water solution pH

pH of 30%w/v solution in water is 4.0-6.8

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

Packaging and storage

Preserve in well-closed containers and store at room temperature.

Protect from moisture.

The role in ophthalmic medicine

Betadex sulfobutyl ether sodium has little stimulation on cornea and can reduce the irritation of drugs on the eyeball, so it is very suitable for the preparation of eye drops with physiological pH and osmotic pressure requirements.

Ganciclovir was soluble in water, but the water solubility was significantly affected by pH, more easily in dissolved under acidic conditions. The pH and osmotic pressure of the eyedrops are strictly required. The results showed that the Betadex sulfobutyl ether sodium in the prescription significantly reduced the eye irritation of ganciclovir, and the inclusion of Betadex sulfobutyl ether sodium on the drug could increase the biocompatibility of the eye drops.

O,O’-Dipropionyl-(1,4-xylylene) bispilocarpate is a precursor of trabeculin, a drug for glaucoma treatment. It has a strong irritation to the eye and affects its clinical application. After adding Betadex sulfobutyl ether sodium to the prescription of the eye drops, it was found that the irritation of Betadex sulfobutyl ether sodium eye drops to rabbit eyes was significantly reduced within the range of 24 ~ 36mmol. L-1. The mechanism may be that when the drug forms a inclusion compound with Betadex sulfobutyl ether sodium, the inclusion compound can slowly release the drug in the eye, so as to reduce the local concentration of the free drug and reduce or eliminate the eye irritation caused by the rapid absorption or precipitation of the drug.

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