Products Application
Sulfobutyl ether beta cyclodextrin sodium ( Betadex sulfobutyl ether sodium, SBE-β-CD ) 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.
Specification ( USP Standard)
| Iterm |
Specification |
| Appearance | White to off-white, amorphous powder |
| Solubility | Freely soluble in water and in propylene glycol |
| Identification | IR The infrared absorption spectrum is consistent with that of the Standard |
| HPLC | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution |
| Average Degree of Substitution | Meets the requirements of the test for Average Degree of Substitution |
| Sodium | Gives the reactions of the Sodium |
| Clarity | The solution is clear and essentially free from particles of foreign matter |
| Assay ( % ) | 95.0-105.0 |
| Heavy Metals ( ppm ) | ≤5 |
| Limit of Beta Cyclodextrin ( Betadex ) ( % ) | ≤0.1 |
| Limit of 1,4-Butane Sultone ( ppm ) | ≤0.5 |
| Limit of Sodium Chloride ( % ) | ≤0.2 |
| Limit of 4-Hydroxybutane-1-sulfonic Acid ( % ) | ≤0.09 |
| Limit of and Bis( 4-sulfobutyl )Ether Disodium ( % ) | ≤0.05 |
| Bacterial Endotoxins ( EU/g) |
<20 |
| The total aerobic microbial ( CFU/g ) | ≤100 |
| The total combined molds and yeasts ( CFU/g ) | ≤50 |
| Escherichia coli | Absent |
| Average Degree of Substitution | 6.2-6.9 |
| Peaks Ⅰ-Ⅹ ( peak area ) | Ⅰ 0.0-0.3 |
| Ⅱ | 0.0-0.9 |
| Ⅲ | 0.5-5.0 |
| Ⅳ | 2.0-10.0 |
| Ⅴ | 10.0-20.0 |
| Ⅵ | 15.0-25.0 |
| Ⅶ | 20.0-30.0 |
| Ⅷ | 10.0-25.0 |
| Ⅸ |
2.0-12.0 |
| Ⅹ | 0.0-4.0 |
| pH | 4.0-6.8 |
| Water Determination ( % ) | ≤10 |
