China Largest Manufacturer factory sales USP/EP Grade Sulfobutylether Beta Cyclodextrin sodium/Betadex Sulfobutyl Ether Sodium CAS 182410-00-0

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Betadex Sulfobutyl Ether Sodium Basic information Product Name: Betadex Sulfobutyl Ether Sodium Synonyms: .beta.-Cyclodextrin, sulfobutyl ethers, sodium salts;SBE-β-CD(Sulfobutyl Ether-β-cyclodextrin Sodium salt);BETADEX SULFOBUTYL ETHER SOIDUM;sulfobutyl ether sodium salt;betadex sulfobuytl ether sodium;β-Cyclodextrin, sulfobutyl ethers;Sulfobutylated beta-cyclodextrin sodium salt (DS~4);Sulfobutylated beta-cyclodextrin sodium salt (DS~6) CAS: 182410-00-0 MF: C42H70O35 MW: 1134.9842 EINECS: 1308068-626-2 Product Categories: Pharmaceutical Mol File: 182410-00-0.mol   Betadex Sulfobutyl Ether Sodium Chemical Properties Melting point  202-204°C (dec.) storage temp.  Inert atmosphere,Room Temperature solubility  Soluble in water. Insoluble in acetone, methanol, chloroform. form  Solid powder color  White to off white   Safety Information HS Code  2940006000 MSDS Information   Betadex Sulfobutyl Ether Sodium Usage And Synthesis Chemical Properties β-Cyclodextrin, sulfobutyl ethers, sodium salts is White powder. Chemical Properties β-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. Uses β-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. Uses SBE- β –CD is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Uses β-Cyclodextrin 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 is commonly used to produce HPLC columns allowing chiral enantiomers separation. Production Methods Sulfobutylether 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 Applications Cyclodextrins 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. Safety Sulfobutylether 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. storage Sulfobutylether 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. Incompatibilities The preservative activity of benzalkonium chloride is reduced in the presence of sulfobutylether b-cyclodextrin. Regulatory Status Sulfobutylether 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.   Betadex Sulfobutyl Ether Sodium Preparation Products And Raw materials

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Leader Biochemical Group is a large leader incorporated industry manufacturers and suppliers of advanced refined raw materials From the year of 1996 when our factory was put into production to year of 2020, our group has successively invested in more than 52 factories with shares and subordinates.We focus on manufacture Pharm & chemicals, functional active ingredients, nutritional Ingredients, health care products, cosmetics, pharmaceutical and refined feed, oil, natural plant ingredients industries to provide top quality of GMP standards products.All the invested factories' product lines cover API and intermediates, vitamins, amino acids, plant extracts, daily chemical products, cosmetics raw materials, nutrition and health care products, food additives, feed additives, essential oil products, fine chemical products and agricultural chemical raw materials And flavors and fragrances. Especially in the field of vitamins, amino acids, pharmaceutical raw materials and cosmetic raw materials, we have more than 20 years of production and sales experience. All products meet the requirements of high international export standards and have been recognized by customers all over the world. Our manufacture basement & R&D center located in National Aerospace Economic & Technical Development Zone Xi`an Shaanxi China. Now not only relying on self-cultivation and development as well as maintains good cooperative relations with many famous research institutes and universities in China. Now, we have closely cooperation with Shanghai Institute of Organic Chemistry of Chinese Academy of Science, Beijing Institute of Material Medical of Chinese Academy of Medical Science, China Pharmaceutical University, Zhejiang University. Closely cooperation with them not only integrating Science and technology resources, but also increasing the R&D speed and improving our R&D power. Offering Powerful Tech supporting Platform for group development. Keep serve the manufacture and the market as the R&D central task, focus on the technical research.  Now there are 3 technology R & D platforms including biological extract, microorganism fermentation and chemical synthesis, and can independently research and develop kinds of difficult APIs and pharmaceutical intermediates. With the strong support of China State Institute of Pharmaceutical Industry (hereinafter short for CSIPI), earlier known as Shanghai Institute of Pharmaceutical Industry (SIPI), we have unique advantages in the R & D and industrialization of high-grade, precision and advanced products.  Now our Group technical force is abundant, existing staff more that 1000 people, senior professional and technical staff accounted for more than 50% of the total number of employees, including 15 PhD research and development personnel, 5 master′ S degree in technical and management personnel 9 people. We have advanced equipment like fermentation equipment and technology also extraction, isolation, purification, synthesis with rich production experience and strict quality control system, According to the GMP required, quickly transforming the R&D results to industrial production in time, it is our advantages and our products are exported to North and South America, Europe, Middle East, Africa, and other five continents and scale the forefront in the nation, won good international reputation.  We believe only good quality can bring good cooperation, quality is our key spirit during our production, we are warmly welcome clients and partner from all over the world contact us for everlasting cooperation, Leader will be your strong, sincere and reliable partner in China.

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