sulfobutyl ether-beta-cyclodextrin sodium salt

ITEMS

SPECIFICATION

RESULTS

Appearance

White to off-white solid, free    from foreign matter

Qualify

           Solution Clarity             

A *0%w/v solution in water is    clear and essentially free from particles of foreign matter

Qualify

Identification (IR)

Consistent with SBECD standard

Qualify

Sodium Identification

Identify test are positive for    Sodium

+

Average Degree of Substitution

6.**6.9

6.7

SBE 1 Content

≤0.2%

0.*5%

SBE 2 Content

≤0.8%

0.*5%

Water solution pH

pH of    *0%w/v solution in water is 4.**6.8

5.4

Heavy Metals

≤5ppm

 

Water

≤*0%

4.0%

β-Cyclodextrin Content

≤0.1%

Absence

Sodium Chloride

≤0.2%

0.*1%

1,*-butane sultone

≤0.5ppm

0.3ppm

*-Hydroxybutane**-Sulfonic Acid

≤0.*9%

0.*1%

Disodium bis-(*-sulfobtyl) ether

≤0.*5%

0.*5%

Assay

*5%***5%