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. Betadex Sulfobutyl Ether Sodium CAS NO 182410-00-0 Sulfobutyl Beta Cyclodextrin Sodium
We are specialized in the production of betadex sulfobutyl ether sodium. It is leading manufacturer of Pharmaceutical Excipients in China. Name: betadex sulfobutyl ether sodium DMF No: 034773 / Injection grade / USP Standard Name: Injection grade betadex sulfobutyl ether sodium CAS: 182410-00-0
Betadex Sulfobutyl Ether Sodium CAS NO 182410-00-0 Sulfobutyl Beta Cyclodextrin Sodium 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 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.
[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
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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 |
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Identification A/IR; USP<197K> |
Complies with SBECD reference |
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Identification B/(Assay method)HPLC; USP<621> |
tR of the major peak complies with SBECD reference |
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Identification C/CE; USP<1053> |
It meets the requirements of the test for Average Degree of Substitution. |
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Identification D/USP<191> |
Positive test for sodium |
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Assay/HPLC;USP<621> |
95.0%-105.0% on the anhydrous basis |
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Limit of Beta Cyclodextrin(Betadex)/IC; USP<621>;USP<1065> |
NMT 0.1% |
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Limit of 1,4-Butane Sultone /GC;USP<621>, |
NMT 0.5ppm |
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Limit of Sodium chloride /IC; USP<621>;USP<1065> |
NMT 0.2% |
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Limit of 4-Hydroxybutane-1-sulfonic acid /IC;USP<621>;USP<1065> |
NMT 0.09% |
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Limit of Bis(4-sulfobutyl) ether disodium /IC;USP<621>;USP<1065> |
NMT 0.05% |
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Bacterial Endotoxins Test/USP<85> |
≤10EU/g |
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Microbial Enumeration Tests/USP<61> |
TAMC≤100cfu/g TYMC≤50 cfu/g |
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Tests for Specified Microorganisms/USP<62> |
Absence of Escherichia Coli/1g |
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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. |
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Average Degree of Substitution [DS]/CE;USP<1053> |
6.2-6.9 |
The potential of beta-cyclodextrins as a pharmaceutical aid has been established through several decades of research. However, some beta-cyclodextrins are reported to be toxic causing deleterious effects on long term usage. In the recent past, Sulfobutyl Ether Beta Cyclodextrin Sodium, a modified beta-cyclodextrin has captured interest as a comparatively safer and effective beta-cyclodextrin for increasing the solubility and the bioavailability of biopharmaceutical classification system class II drugs. Sulfobutyl Ether Beta Cyclodextrin Sodium has demonstrated immense potential in addressing solubility and stability issues associated with formulation of drugs.
Our factory was established in 1999 and has focused on the production of cyclodextrin for more than 20 years. The Sulfobutyl Ether Beta Cyclodextrin Sodium produced by our factory has high yield, low price and guaranteed quality, we welcome you to inquire about the product details.
