Another name for Betadex Sulfobutyl Ether Sodium is Sulfobutyl Ether Beta Cyclodextrin Sodium a new type of highly dissolved cyclodextrin, and Deli is a professional cyclodextrin manufacturer in China. Sulfobutyl Ether Beta Cyclodextrin Sodium Cas 182410-00-0
Sulfobutyl Ether Beta Cyclodextrin Sodium Cas 182410-00-0 is a new type of anionic high soluble cyclodextrin derivatives in China DELI, which can be used as a solubilizer, wetting agent, chelating agent (complexing agent) and polyvatent masking agent.
Sulfobutyl Ether Beta Cyclodextrin Sodium Cas 182410-00-0 has been used in injection, oral, nasal and eye medicines. It has a special affinity and inclusion for nitrogen drugs. Increase the drug's stability ,solubility ,safety (Include drug molecules to form non-covalent). Reduce renal toxicity, ease drug hemolysis. Sulfobutyl Ether Beta Cyclodextrin Sodium also can control the drug release rate, cover the bad smell.
Sulfobutyl Ether Beta Cyclodextrin Sodium Cas 182410-00-0
[CAS NO]: 128410-00-0
[Molecular formula]: C42H70-nO35·(C4H8SO3Na)n
[Grade]: Injection grade
[Executive standard]: USP/EP/Enterprise standard
[Specification]: 500g/Bag; 1kg/Bag; 10kg/bag; 10kg/drum.
[Application Area]: Medicine
|
Description and Solubility/ see details in the USP Monograph |
White to off-white,amorphous powder.Freely soluble in water;sparingly soluble in methanol;practically insoluble in ethanol,in n-hexane,in 1-butanol,in acetonitrile,in 2-propanol,and in ethylacetate |
|
Identification A/IR; USP<197K> |
Complies with SBECD reference |
|
Identification B/(Assay method)HPLC; USP<621> |
tR of the major peak complies with SBECD reference |
|
Identification C/CE; USP<1053> |
It meets the requirements of the test for Average Degree of Substitution. |
|
Identification D/USP<191> |
Positive test for sodium |
|
Assay/HPLC;USP<621> |
95.0%-105.0% on the anhydrous basis |
|
Limit of Beta Cyclodextrin(Betadex)/IC; USP<621>;USP<1065> |
NMT 0.1% |
|
Limit of 1,4-Butane Sultone /GC;USP<621>, |
NMT 0.5ppm |
|
Limit of Sodium chloride /IC; USP<621>;USP<1065> |
NMT 0.2% |
|
Limit of 4-Hydroxybutane-1-sulfonic acid /IC;USP<621>;USP<1065> |
NMT 0.09% |
|
Limit of Bis(4-sulfobutyl) ether disodium /IC;USP<621>;USP<1065> |
NMT 0.05% |
|
Bacterial Endotoxins Test/USP<85> |
≤10EU/g |
|
Microbial Enumeration Tests/USP<61> |
TAMC≤100cfu/g TYMC≤50 cfu/g |
|
Tests for Specified Microorganisms/USP<62> |
Absence of Escherichia Coli/1g |
|
Clarity of Solution(30%,w/v)/visual;see details in the USP Monograph |
The solution is clear, and essentially free from particles of foreign matter. |
|
Average Degree of Substitution [DS]/CE;USP<1053> |
6.2-6.9 |
