Product Details
Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
1.Product Introduction
This Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.
2.Basic information
Product Name : Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
CAS NO.: 182410-00-0
Synonyms : BETADEX SULFOBUTYL ETHER SODIUM
Molecular Formula: C42H70-nO35 (C4H8O3S Na)n
Molecular Weight : 1135+158n
3.Product Specification of Sulfobutyl Ether-Beta-Cyclodextrin Sodium Salt
Standard |
USP41-NF36 |
ITEMS |
SPECIFICATION |
Clarity of Solution |
A 30%w/v solution in water is clear and essentially free from particles of foreign matter |
Identification (IR) |
Same absorption bands as USP betadex sulfobutyl ether sodium RS |
Identification(Sodium) |
Identify test are positive for Sodium |
Identification（LC） |
the retention time of the major peak of sample solution corresponds to the standard solution |
Average Degree of Substitution |
6.2-6.9 |
Water solution pH |
pH of 30%w/v solution in water is 4.0-6.8 |
Heavy Metals |
≤5ppm |
Water content |
≤10.0% |
β-Cyclodextrin Content |
≤0.1% |
Sodium Chloride |
≤0.2% |
1,4-butane sultone |
≤0.5ppm |
4-Hydroxybutane-1-Sulfonic Acid |
≤0.09% |
Disodium bis-(4-sulfobtyl) ether |
≤0.05% |
Assay |
95.0%-105.0% |
Bacterial endotoxins |
≤20EU/g |
Microbiology |
|
TAMC ( cfu/g) |
≤100 cfu/g |
TYMC ( cfu/g) |
≤50 cfu/g |
Escherichia Coli |
Absence |
4. Application of SBECD
◆ Improve the stability of the drug, water solubility, safety
◆ Reduce renal toxicity, ease drug hemolysis
◆ Control the drug release rate, cover the bad smell
5.Packing & Shipping
Packing Detail : 500g/bag, 1kg/bag, 2kg/bag, 10kg/drum, 20kg/drum or customized
Shipping: by Express.Shipped by air or by sea
6.Delivery & Payment
Payment : T/T in advance to our remittance route for US dollors
Delivery : Goods can be sent immediately after receipt the payment.
Availability : In stock
Port of loading : factory of Zhiyuan(China)
7.FAQ
● Is there an established, documented Quality System that is maintained to ensure products conform to requirements?
● Yes
● Is the excipient manufactured as a continuous or a batched process?
● Batched process
● Are there complete written manufacturing instructions, as controlled GMP documents?
● Yes
● Is the manufacturing process validated?
● Yes
● Do you use any Class I, Class II, or Class III solvents specified in the USP during the manufacturing of the excipient(s)?
● No
http://www.zhiyuan-cydextrin.com/
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