外觀

Appearance

白色無定形粉末（CDE登記標準）

白色或幾乎白色無定形粉末（USP）

White or almost white, amorphous or crystalline powder

白色無定形粉末

White amorphous powder

溶解度

Solubility

易溶于水

Freely soluble in water

符合規(guī)定

Conform

鑒別

IDENTIFICATION

紅外光譜

IR

樣品的紅外吸收圖譜應與對照品的紅外圖譜一致The infrared absorption spectrum is consistent with that of the Standard

符合規(guī)定

Conform

HPLC

樣品液主峰的保留時間應與標準液的保留時間一致

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

符合規(guī)定

Conform

平均取代度

Average Degree of Substitution

應符合平均取代度的規(guī)定

Meets the requirements of the test for Average Degree of Substitution

符合規(guī)定

Conform

鈉

Sodium

呈鈉鹽反應

Gives the reactions of Sodium

符合規(guī)定

Conform

澄清度

Clarity

應澄清

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

符合規(guī)定

Conform

含量

ASSAY (%)

95.0-105.0

99.8

重金屬

Heavy Metals (ppm)

≤5

＜5

倍他環(huán)糊精

Limit of Beta Cyclodextrin (Betadex) (%)

≤0.1

0.014

1,4-丁烷磺內(nèi)酯

Limit of 1,4-Butane Sultone(ppm)

≤0.5

0.11

氯化鈉

Limit of Sodium Chloride (%)

≤0.2

0.0049

4-羥基丁烷-1-磺酸

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

≤0.09

未檢出

Absent

雙（4-磺丁基）醚二鈉

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

≤0.05

未檢出

Absent

細菌內(nèi)毒素

Bacterial Endotoxins (EU/mg)

＜0.02

<0.01

需氧菌總數(shù)

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

大腸埃希菌

Escherichia coli

不得檢出

Absent

未檢出

Absent

峰Peaks Ⅰ-Ⅹ

（％峰面積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