Betadex Sulfobutyl Ether Sodium CAS 182410-00-0

Appearance

White to off‑white, amorphous powder.

Conform

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.

Conform

Identification‑IR

Same absorption bands as USP betadex sulfobutyl ether   sodium RS.

Conform

Identification‑HPLC

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

Conform

Identification‑Average degree of substitution

Conform

Conform

Identification‑Sodium

Identify test are positive for Sodium.

Conform

Assay (on the anhydrous basis)

95.0%~105.0%

102.8%

Betadex

≤0.1%

Not detected

1,4‑butane sultone

≤0.5ppm

0.11ppm

Sodium chloride

≤0.2%

0.01%

4‑hydroxybutane‑1‑sulfonic acid

≤0.09%

Not detected

Bis(4‑sulfobutyl) ether disodium

≤0.05%

0.03%

Bacterial endotoxins

<0.01EU/mg

<0.01EU/mg

The total aerobic microbial count

≤100cfu/g

<10cfu/g

The total combined molds and yeasts count

≤50cfu/g

<10cfu/g

Escherichia coli

Absence

Not detected

Average degree of substitution

6.2‑6.9

6.5

Peaks I‑X (% peak area)‑I

0.0‑0.3

0

Peaks I‑X (% peak area)‑II

0.0‑0.9

0.50

Peaks I‑X (% peak area)‑III

0.5‑5.0

2.42

Peaks I‑X (% peak area)‑IV

2.0‑10.0

5.78

Peaks I‑X (% peak area)‑V

10.0‑20.0

11.79

Peaks I‑X (% peak area)‑VI

15.0‑25.0

20.17

Peaks I‑X (% peak area)‑VII

20.0‑30.0

26.70

Peaks I‑X (% peak area)‑VIII

10.0‑25.0

22.23

Peaks I‑X (% peak area)‑IX

2.0‑12.0

8.18

Peaks I‑X (% peak area)‑X

0.0‑4.0

2.22

pH

4.0‑6.8

6.6

Water determination

≤10.0%

6.0%

Clarity of solution

30%(w/v) solution is clear and essentially free from   particles of foreign matter.

Conform