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Certificate of Analysis for Betadex Sulfobutyl Ether Sodium

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  • Time of issue:2021-08-25
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(Summary description)

Certificate of Analysis for Betadex Sulfobutyl Ether Sodium

(Summary description)

  • Categories:News
  • Author:
  • Origin:
  • Time of issue:2021-08-2554
  • Views:
Information

Lot No.

SB210608

Package Specification

20 kg/Drum

Manu Date

2021.06.21                          21.Jun.2021  

Expiry Date

2024.06.20       20.Jun.2024

Lot Quantity

260.27kg

Report Date

2021.06.28   28.Jun.2021

Standard

Enterprise Standard and USP-NF2021

Record Code

108716-108728

Item

Specification

Result

Appearance

White to off-white, amorphous powder

White amorphous powder

 

 

 

 

Identification

IR

The infrared absorption spectrum is consistent with that of the Standard

 

 Conform

HPLC

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

Conform

Average Degree of Substitution

Meets the requirements of the test for Average Degree of Substitution  

Conform

Sodium

Gives the reactions of Sodium

Conform

Clarity of Solution

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

Conform

AssayCalculated on the anhydrous basis

95.0~105.0

99.7

Heavy Metalsppm

5

<5

Beta CyclodextrinBetadex)(%

0.1

0.013

1.4-Butane Sultoneppm

0.5

0.020

Sodium Chloride%

0.2

0.0017

4-Hydroxybutane-1-sulfonic

0.09

0.025

Bis4-sulfobutyether Disodium%

0.05

Absent

Bacterial EndotoxinsEU/mg

<0.02

<0.01

The Total Aerobic Microbial Countcfu/g

100

25

The Total Combined Molds and Yeasts

Countcfu/g

50

<10

Escherichia Coli

Absent

Absent

Average Degree of Substitution

6.2~6.9

6.4

 

 

 

Peaks 1-X

%Peak Area

0~0.3

0.10

0~0.9

0.63

0.5~5.0

2.37

2.0~10.0

6.71

10.0~20.0

14.09

15.0~25.0

21.79

20.0~30.0

25.49

10.0~25.0

19.5

2.0~12.0

8.46

Χ

0~4.0

0.86

pH

4.0~6.8

6.4

Water Determination%

10.0

5.3

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