Betadex Sulfobutyl Ether Sodium CAS No. 182410-00-0

Min.Order: 1
Product origin: Changsha, Hunan, China
Infringement complaint: complaintComplaint
US$ 30 ~ 300

Description

Betadex Sulfobutyl Ether Sodium is a sodium salt produced when betacyclodextrin is alkylated by 1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble betacyclodextrin derivative. Betadex Sulfobutyl Ether Sodium is can be well combined with the drug molecules to form non-covalent complex, thereby enhancing the stability, water solubility, and safety of the drug, reducing its renal toxicity, easing drug hemolysis, controlling drug release rate, covering bad smell, etc. Compared with betacyclodextrin, sulfobutyl betacyclodextrin sodium has a higher water solubility, smaller hemolytic effect, and lower renal toxicity, which make it a new pharmaceutical excipient with very broad application prospects.
 

Betadex Sulfobutyl Ether Sodium ( EP9.6)
CONTENT
SULFOBUTYLBETADEX SODIUM98.0%-102.0%
AVERAGE DEGREE OF SUBSTITUTION5.9-6.6
CHARACTERS
APPEARANCEwhite or almost white, hygroscopic powder
SOLUBILITYfreely soluble in water, practically insoluble in anhydrous ethanol and in nehloride
IDENTIFICATION
A INFRAED ABSORPTION SPECTROPHOTOMETRYsame absorption bands. the relative intensity of some absorption bands may vary.
B SODIUM REACTIONit gives reaction (a) of sodium
TEST
PH5.0-7.5
APPEARANCE OF SOLUTIONclear and colorless
REDUCING SUGARSNMT 0.05%
IMPURITIES
Limit of betadexNMT 0.1%
Limit of 1'2λ6-oxathiane-2,2-dioneNMT 0. 5ppm
Limit of 4-hydroxybutane-1-sulfonic acidNMT 0. 1%
Limit of 4,4'-oxydi(butane-1-sulfonic acid)NMT 0. 05%
LIMIT OF SODIUM CHLORIDENMT 0.20%
WATERNMT10.0%
MICROBIAL CONTAMINATION
the total aerobic microbial countNMT 100cfu/g
the total combined molds and yeasts countNMT 100cfu/g
Escherichia coli.absence
Salmonellaabsence



 

β-Cyclodextrin, sulfobutyl ethers, sodium salts Basic information
Product Name:β-Cyclodextrin, sulfobutyl ethers, sodium salts
Synonyms:CAPTISOL;Sodium sulfobutylether β-cyclodextrin;Betadex Sulfobutyl Ether Sodium (500 mg);sulfobutyl ether B-cyclodextrin;sodiuM salts;sulfobutyl ethers;SodiuM Sulphobutylether-β-Cyclodextrin;CAPTISOL,BETA-CYCLODEXTRIN SULFOBUTYL ETHERS, SODIUM SALT
CAS:182410-00-0
MF:C42H70O35
MW:1134.9842
EINECS:1308068-626-2
Product Categories: 
Mol File:182410-00-0.mol
 
 
β-Cyclodextrin, sulfobutyl ethers, sodium salts Chemical Properties
solubility Soluble in water. Insoluble in tone, metnol, choform.
form Solid powder
color White to off white
 
Safety Information
HS Code 2940006000
 
MSDS Information
 
 
β-Cyclodextrin, sulfobutyl ethers, sodium salts Usage And Synthesis
Chemical Propertiesβ-Cyclodextrin, sulfobutyl ethers, sodium salts is White powder.
Chemical Propertiesβ-Cyclodextrin, sulfobutyl ethers, sodium salts is a cyclic oligosaccharide containing seven D-(t)- glucopyranose units attached by α(1→4) glucoside bonds. Sulfobutylether b-cyclodextrin is an anionic bcyclodextrin derivative with a sodium sulfonate salt separated from the hydrophobic cavity by a butyl spacer group. The substituent is introduced at positions 2, 3, and 6 in at least one of the glucopyranose units in the cyclodextrin structure. Introducing the sulfobutylether (SBE) into b-cyclodextrin can produce materials with different degrees of substitution, theoretically from 1 to 21; the hepta-substituted preparation (SBE7-b-CD) is the cyclodextrin with the most desirable drug carrier properties. Sulfobutylether b-cyclodextrin occurs as a white amorphous powder.
Usesβ-Cyclodextrin, sulfobutyl ethers, sodium salts with sulfobutyl ether groups and sodium ions substituted along the length of the molecule. β-Cyclodextrin is a cyclic oligosaccharide produced from starch via enzymatic conversion. β-Cyclodextrin, sulfobutyl ethers, sodium salts is commonly used to produce HPLC columns allowing chiral enantiomers separation.
UsesSBE- β -CD is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.
Production MethodsSulfobutylether β-cyclodextrin is prepared by alkylation of bcyclodextrin using 1,4-butane sultone under basic conditions. The degree of substitution in b-cyclodextrin is controlled by the stoichiometric ratio of β-cyclodextrin to sultone used in the process.
Pharmaceutical ApplicationsCyclodextrins are crystalline, nonhygroscopic, cyclic oligosaccharides derived from starch (see Cyclodextrins). Sulfobutylether bcyclodextrin is an amorphous, anionic substituted b-cyclodextrin derivative; other substituted cyclodextrin derivatives are also available.
Sulfobutylether b-cyclodextrin can form noncovalent complexes with many types of compounds including small organic molecules, peptides, and proteins. It can also enhance their solubility and stability in water. The first application of sulfobutylether bcyclodextrin was in injectable preparations; it can also be used in oral solid and liquid dosage forms, and ophthalmic, inhalation, and intranasal formulations. Sulfobutylether bcyclodextrin can function as an osmotic agent and/or a solubilizer for controlled-release delivery, and has antimicrobial preservative properties when present at sufficient concentrations.
The amount of sulfobutylether β-cyclodextrin that may be used is dependent on the purpose for inclusion in the formulation, the route of administration, and the ability of the cyclodextrin to complex with the drug being delivered. The minimum amount required for solubilization is, in general, a cyclodextrin/drug molar ratio of approximately 1-5 (the exact ratio being experimentally determined from complexation data). The maximum use in a formulation may be limited by physicochemical constraints such as viscosity (e.g. syringeable concentrations may be considered up to 50% w/v), tonicity, or the total weight and size of solid dosage forms (e.g. less than a gram in an individual tablet). It may also be limited by pharmacokinetic/pharmacodynamic (PK/PD) considerations. As dilution of a cyclodextrin formulation leads to an increase in the amount of uncomplexed drug, formulations that are not diluted upon administration, such as ophthalmic formulations, are sensitive to cyclodextrin concentration. In formulations such as these, cyclodextrin concentrations greater than the minimum required for solubilization can reduce the availability of uncomplexed drug and thereby affect PK/PD expectations by producing effects such as slower onset, lower Cmax, and bioavailability.
SafetySulfobutylether b-cyclodextrin is derived from b-cyclodextrin, which is nephrotoxic when administered parenterally. However, studies have shown that sulfobutylether bcyclodextrin is well tolerated at high doses, when administered via intravenous bolus injections, orally, and by inhalation. Up to 9 g/day may be administered by IV infusion in a licensed voriconazole formulation. The safety following high doses of sulfobutylether β-cyclodextrin intravenous administration in humans is continually being investigated.
Sulfobutylether β-cyclodextrin has been subjected to an extensive battery of in vitro and in vivo genotoxicity and pharmacological evaluations. No genotoxic or mutagenic changes were observed with sulfobutylether β-cyclodextrin administration. Sulfobutylether β-cyclodextrin is biocompatible and exhibits no pharmacological activity. It is rapidly eliminated unmetabolized when administered intravenously.
storageSulfobutylether b-cyclodextrin is stable in the solid state and should be protected from high humidity. It should be stored in a tightly sealed container in a cool, dry place.
It will reversibly take up moisture without any effect on the appearance of the material at humidities up to 60% RH. Equilibration at RH values above 60% will result in deliquescence. Once in this state, the material can be dried, but will give a glasslike product. This water absorption behavior is typical of amorphous hygroscopic materials.
Sulfobutylether b-cyclodextrin is stable in aqueous solutions at values above about pH 1. It can degrade in highly acidic (pH < 1) solutions, particularly at elevated temperatures, producing the ring-opened form, followed by hydrolysis of the a(1-4) glucoside bonds.
Sulfobutylether b-cyclodextrin solutions may be autoclaved.
IncompatibilitiesThe preservative activity of benzalkonium chloride is reduced in the presence of sulfobutylether b-cyclodextrin.
Regulatory StatusSulfobutylether β-cyclodextrin is included in IV and IM injectable products currently approved and marketed in the USA, Europe, and Japan. It is included in the FDA Inactive Ingredients Database for IM and IV use. Its use by other routes, including SC, oral, inhalation, nasal and ophthalmic, is being evaluated in clinical studies.




Hunan JK International Trade Corporation / JK BIO-CHEM CO.,LTD is a professional exporter of food/feed additives and food /feed ingredients in China. With years of development, now we are able to provide the following food additives and food ingredients: thickeners, antioxidants, preservatives, vitamins, sweeteners, proteins, acidulants, nutritional supplements, flavours, coenzyme and so on.
Our food additives and food ingredients, especially our Ascorbic Acid (Vitamin C), Acesulfame-K, Aspartame, Citrates, Dextrose, D-Xylose, Erythorbic Acid, Fumaric Acid, Fructose,Maltodextrin, Malic Acid, Monosodium glutamate, Lactic Acid Potassium Sorbate, Sodium Erythorbate, Sodium Cyclamate, Sodium Saccharin, sodium benzoate, Sodium ascorbate, Sorbic Acid, xanthan Gum, Xylitol, Tartaric Acid, I+G, , Vanillin, Sucralose, Stevia and so on, have been exported to more than 60 countries for our good quality products.
Our staff of sales and technical support is available to help you in selecting the right protection for your application as well as to provide you with samples of our products for evaluation. At High Five, we are committed to providing the highest level of customer service, competitive pricing, speedy delivery and a comprehensive, cutting-edge product offering. Our ultimate goal is your satisfaction.





Packing&Shipping 


FAQ

Q1.What's the payment terms?
We could accept T/T, L/C, DP payment terms.

Q2.How about the different index of products in same application?
Specifications can be customized according to your application.

Q3.How about the samples of products?
We can provide free samples under 2Kg(not including freight charge).

Q4.How about the price of products?
Our products are chemical synthesis got from underground brine, which is available for a variety of usage. Our products are high purity with good quality, and the price is based on different specification and quantity.

Q5.What's the shelf life for the cargoes?
Our product's shelf life is 2 years, which is based on dry and ventilated storage.

Q6.What's the package of the cargoes?
20kg/25kg woven bags, within plastic bags, or as customized.

Q7.What's the delivery time?
We usually deliver the cargoes within 10~20 days after receiving customer's payment or original L/C.


Q8.Which documents can we supply?
Commercial Invoice, Packing List, Certificate of Analysis, Certificate of Origin (FORM E), Bill of Loading, ISO etc.
The documents will be sent by Express within 24 hours against your full payment.

Q9.Why do you choose us?
We accept safe and diversified payment terms.
We supply a price trend to ensure clients know marketing information in time. We will take charge of 100% responsibility for
quality issue. We strive to create value for each customer we serve by meeting their unique needs and providing solutions to solve their problems and achieve their objectives.















 

Scroll to Top