item

spec

Appearance

white to off-white powder

Identification A

To comply with the standard IR trace

Identification B

RTof the main peak shoul meet the limit

Identification C

6.2-6.9 for average degree of substitution

Identification D

Test for sodium

Solution clarity

30% solution in water is clear

PH of solution

The ph of 30% solution within 4.0-6.8

Water content (KF)

≤10.0%

Heavy metal

≤5ppm

1,4-butane sultone

≤0.5ppm

4-hydroxybutane-1-sulfonic acid

≤0.09%

Bis(4-sulfobutyl)ether disodium

≤0.05%

Beta-cyclodextrin

≤0.1%

Sodium chloride

≤0.2%

The total Aerobic count

≤100 CEU/g

Moulds and Yeasts

≤100CEU/g

Escherichia coli

Negative

Bcterial endotoxin

≤25 IU/g

Assay(by HPLC)

95.0-105.0%