项目

Item

指标

Specification

检验结果

Result

外观

Appearance

白色无定形粉末（CDE登记标准）

白色或几乎白色无定形粉末（USP）

White or almost white, amorphous or crystalline powder

白色无定形粉末

White amorphous powder

溶解度

Solubility

易溶于水

Freely soluble in water

符合规定

Conform

鉴别

IDENTIFICATION

红外光谱

IR

样品的红外吸收图谱应与对照品的红外图谱一致The infrared absorption spectrum is consistent with that of the Standard

符合规定

Conform

HPLC

样品液主峰的保留时间应与标准液的保留时间一致

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution

符合规定

Conform

平均取代度

Average Degree of Substitution

应符合平均取代度的规定

Meets the requirements of the test for Average Degree of Substitution

符合规定

Conform

钠

Sodium

呈钠盐反应

Gives the reactions of Sodium

符合规定

Conform

澄清度

Clarity

应澄清

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

符合规定

Conform

含量

ASSAY (%)

95.0-105.0

99.8

重金属

Heavy Metals (ppm)

≤5

＜5

倍他环糊精

Limit of Beta Cyclodextrin (Betadex) (%)

≤0.1

0.014

1,4-丁烷磺内酯

Limit of 1,4-Butane Sultone(ppm)

≤0.5

0.11

氯化钠

Limit of Sodium Chloride (%)

≤0.2

0.0049

4-羟基丁烷-1-磺酸

Limit of 4-Hydroxybutane-1-sulfonic Acid (%)

≤0.09

未检出

Absent

双（4-磺丁基）醚二钠

Limit of and Bis(4-sulfobutyl) Ether Disodium (%)

≤0.05

未检出

Absent

细菌内毒素

Bacterial Endotoxins (EU/mg)

＜0.02

<0.01

需氧菌总数

The total aerobic microbial (CFU/g)

≤100

15

霉菌和酵母菌

The total combined molds and yeasts (CFU/g)

≤50

＜10

取代度

Average Degree of Substitution

6.2–6.9

6.5

大肠埃希菌

Escherichia coli

不得检出

Absent

未检出

Absent

峰Peaks Ⅰ-Ⅹ

（％峰面积Peak Area）

Ⅰ

0.0-0.3

0.00

Ⅱ

0.0-0.9

0.55

Ⅲ

0.5-5.0

2.23

Ⅳ

2.0-10.0

5.98

Ⅴ

10.0-20.0

12.01

Ⅵ

15.0-25.0

20.71

Ⅶ

20.0-30.0

25.00

Ⅷ

10.0-25.0

19.86

Ⅸ

2.0-12.0

10.06

Ⅹ

0.0-4.0

3.60

pH

4.0-6.8

6.2

水分

Water Determination(%)

≤10

4.7