Betadex Sulfobutyl Ether Sodium
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 |
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 |
||
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.
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