Betadex Sulfobutyl Ether Sodium（β-Cyclodextrin, sulfobutyl ethers, sodium salts）

ASSAY

SPECIFICATION

【IDENTIFICATION】

A Infraredabsorption

Complies with SBECD reference

B Content Analysis

tR of the major peak complies with SBECD  reference

C Average Degree of Substitution.

meets the requirements of the test for Average Degree of Substitution.

D GENERAL,Sodium

Positive test for sodium

【ASSAY】

THE PERCENTAGE OF BETADEX SULFOBUTYL ETHER SODIUM

95.0%-105.0%

【IMPURITIES】

LIMIT OF BETADEX

NMT 0.1%

LIMIT OF 1,4-BUTANE SULTONE

NMT 0. 5ppm

LIMIT OF SODIUM CHLORIDE,4-HYDROXYBUTANE-1-SULFONIC ACID,AND BIS(4-SULFOBUTYL) ETHER DISODIUM

Sodium chloride

NMT 0.2%

4-Hydroxybutane-1-sulfonic acid

NMT 0. 09%

(4-sulfobutyl) disodium

NMT 0. 05%

【SPECIFIC TESTS】

BACTERIAL ENDOTOXINS TEST

≤10EU/g

Microbial Enumeration Tests

The total aerobic microbial count

NMT 100cfu/g

The total combined molds and yeasts count

NMT 50cfu/g

Tests for Specified Microorganisms

Absence of Escherichia Coli/1g

Clarity of Solution(30%,w/v)

The solution is clear ,and essentially free from particles of foreign matter

AVERAGE DEGREE OF SUBSTITUTION

6.2-6.9

Ether Sodium Peaks I -X

Limit Range(%Peak Area)

I

0-0.3

II

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

0-4.0

PH

4.0-6.8

WATERDETERMINATION

NMT10%