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Betadex Sulfobutyl Ether Sodium
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Betadex Sulfobutyl Ether Sodium

Appearance:White powder,sweet,insipid and innocuous Shelf life:36 Months Grade:Injection Application:Pharmaceuticals Molecular Weight:1347 Standard:USP-NF2022,EP10.3, In-house Standard Solubility:≥100(25℃,g/100ml) Heavy metal:≤0.0025%
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Product description
Parameters

Technical Parameter

Appearance:White powder,sweet,insipid and innocuous

Shelf life:36 Months

Grade:Injection

Application:Pharmaceuticals

Molecular Weight:1347

Standard:USP-NF2022,EP10.3,In-house Standard

Solubility:≥100(25℃,g/100ml)

Heavy metal:≤0.0025%

Specification :

Item

Specification

Result

Appearance

White or almost white, amorphous or crystalline powder

White amorphous powder

Solubility

Freely soluble in water

Conform

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

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

Conform

ASSAY (%)

95.0-105.0

99.8

Heavy Metals (ppm)

≤5

5

Limit of Beta Cyclodextrin (Betadex) (%)

≤0.1

0.014

Limit of 1,4-Butane Sultone(ppm)

≤0.5

0.11

Limit of Sodium Chloride (%)

≤0.2

0.0049

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

≤0.09

Absent

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

≤0.05

Absent

Bacterial Endotoxins (EU/mg)

0.02

<0.01

The total aerobic microbial (CFU/g)

≤100

15

The total combined molds and yeasts (CFU/g)

≤50

10

Average Degree of Substitution

6.2–6.9

6.5

Escherichia coli

Absent

Absent

%峰面积Peak Area

0.0-0.3

0.00

0.0-0.9

0.55

0.5-5.0

2.23

2.0-10.0

5.98

10.0-20.0

12.01

15.0-25.0

20.71

20.0-30.0

25.00

10.0-25.0

19.86

2.0-12.0

10.06

0.0-4.0

3.60

pH

4.0-6.8

6.2

Water Determination(%)

≤10

4.7

      

 

Product Description

Sulfobutyl ether beta cyclodextrin sodium is a new type of anionic high soluble cyclodextrin derivatives. It could include drug molecules to from covalent compounds so that increase the drug’s stability,solubility,safety.It could reduce the renal toxicity,moderate drug’s hemolysis,control the release rate and cover up the bad smell.

It can be used as a solubilizer,wetting agent,chelating agent (complexing agent) and polyvatent masking agent.

It has been used in injection,oral,nasal and eye medicines.It could has a special affinity and inclusion for nitrogen drugs.

We could not find any corresponding parameters, please add them to the properties table

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