Standard

USP41-NF36

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.

HPLC

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

Average Degree of Substitution

Conform

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%

Packaging and storage

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