Assay: 95.0%～105.0%
Heavy metals: ≤5ppm
Beta cyclodextrin: ≤0.1%
1,4-butane sultone: ≤0.5ppm
Sodium chloride: ≤0.2%
4-Hydroxybutane-1-sulfonic acid: ≤0.09%
Disodium bis(4-sulfobutyl) ether: ≤0.05%
Bacterial endotoxin: ≤10EU/g
Total number of aerobic microorganisms ≤100cfu/g
Total mold and yeast: ≤50cfu/g
Clarity of the solution: The solution should be clear and colorless
Average degree of substitution: 5.9-6.9
Moisture: ≤10%
Sulfobutyl Beta Cyclodextrin Sodium is the sodium salt of beta cyclodextrin alkylated by 1,4-butane sultone under alkaline conditions. It is an anionic, highly water-soluble beta cyclodextrin. Essence Derivatives.
Sulfobutyl beta cyclodextrin sodium can be well incorporated with drug molecules to form non-covalent complexes, thereby improving the stability, water solubility and safety of drugs, reducing nephrotoxicity, alleviating drug hemolysis, and controlling drug release. speed, mask bad odor, etc.
Compared with beta-cyclodextrin, it has better water solubility and low hemolysis and nephrotoxicity. It is a new type of pharmaceutical excipient with very broad application prospects.
