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          HYDROXYPROPYL BETADEX

          Hydroxypropyl Betadex is a hydroxyalkylated derivative of Betadex. Hydroxypropyl Betadex can improve the solubility and bioavailability of some insoluble drugs. Therefore, it can effectively  improve the bioavailability of drugs, andcontrol release speed and enhance stability.

          [CAS NO]: 128446-35-5

          DMF 034772

          [Molecular formula]: C42H70O35(C3H6O)x

          [Specification]: 500g/Bag; 10kg/Bag.

          [Category]: Pharmaceutical excipients

          [Storage]: Keep airtight and in a dry place.

          [Period of validity]: 36 months


          ASSAY EP USP
          Appearance White or almost white, amorphous or crystalline powder White or almost white, amorphous or crystalline powder
          Clarity of solution See EP10.0 See USP-NF2021, Issue1
          Loss on drying Maximum 10.0% NMT 10.0%
          Betadex Maximum 1.5% NMT 1.5%
          Propylene glycol Maximum 2.5% NMT 2.5%
          Any other single impurity / NMT 0.25%
          Total impurities excluding betadex and propylene glycol Maximum 1.0% NMT 1.0%
          Propylene oxide / NMT 0.0001%
          Molar substitution 0.40-1.50 0.40-1.50
          Conductivity Maximum 200μS.cm-1 Maximum 200μS.cm-1
          Microbial limit Corporate internal control standards
          The total aerobic microbial count ≤10CFU/g
          The total combined molds and yeasts count ≤10CFU/g
          Escherichia coli Not detectable
          Bacterial endotoxins <10IU/g


          Betadex Sulfobutyl Ether Sodium
                  Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium can bewell combined with the drugmolecules to form non-covalent therebyenhancingthe stability, water solubility, and safety of the drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease rate, covering bad smell, etc.

          [CAS NO]: 128410-00-0

          DMF 034773

          [Molecular formula]: C42H70-nO35·(C4H8SO3Na)n

          [Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.

          [Category]: Pharmaceutical excipients

          [Storage]: Seal preservation.

          [Period of validity]: 36 months


          Betadex Sulfobutyl Ether Sodium ( EP10.0)
          【CONTENT】
          Sulfobutyl Betadex Sodium 95.0%-105.0%
          Average Degree of Substitution 5.9-6.6
          【CHARACTERS】
          Aooearancce white or almost white, hygroscopic powder
          Solubility freely soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride
          【IDENTIFICATION】
          A Infraed Absorption Spectrophotometry

          Complies with SBECD referance

          B Sodium Reaction

          Positive test for sodium

          【TEST】
          PH 5.0-7.5
          Appearance of Solution

          The solution is clear and colourless

          Reducing Sugars NMT 0.05%
          【IMPURITIES】
          Limit of betadex NMT 0.1%
          Limit of 1'2λ6-oxathiane-2,2-dione NMT 0. 5ppm
          Limit of 4-hydroxybutane-1-sulfonic acid NMT 0. 1%
          Limit of 4,4'-oxydi(butane-1-sulfonic acid) NMT 0. 05%
          Limit of soudiun chloride NMT 0.12%
          Water NMT10.0%
          【MICROBIAL CONTAMINATION】
          the total aerobic microbial count NMT 100cfu/g
          the total combined molds and yeasts count NMT 100cfu/g
          Escherichia coli. absence
          Salmonella absence


          Betadex Sulfobutyl Ether Sodium

          Betadex Sulfobutyl Ether Sodium is a sodium salt produced when Betadex is alkylated by1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble Betadex derivative. Betadex Sulfobutyl Ether Sodium can bewell combined with the drugmolecules to form non-covalent therebyenhancingthe stability, water solubility, and safety of the drug, reducingits renal toxicity, easing drughemolysis, controllingdrugrelease rate, covering bad smell, etc.

          [CAS NO]: 128410-00-0

          DMF 034773

          [Molecular formula]: C42H70-nO35·(C4H8SO3Na)n

          [Specification]: 500g/Bag; 1kg/Bag; 10kg/bag/drum.

          [Category]: Pharmaceutical excipients

          [Storage]: Seal preservation.

          [Period of validity]: 36 months


          Betadex Sulfobutyl Ether Sodium (USP-NF2021, Issue 1)

          ASSAY

          SPECIFICATION

          【IDENTIFICATION】

          A

          Complies with SBECD reference

          B

          tR of the major peak complies with SBECD reference

          C

          meets the requirements of the test for Average Degree of Substitution.

          D

          Positive test for sodium

          【ASSAY】

          The Percentage of Betadex SulfobutylL Ether Sodium

          95.0%-105.0% on the anhydrous basis

          【IMPURITIES】

          limit of Beta Cyclodextrin

          NMT 0.1%

          limit of 1,4-Butane Sultone

          NMT 0.5ppm

          limit of Sodium chloride

          NMT 0.2%

          limit of 4-Hydroxybutane-1-sulfonic acid

          NMT 0.09%

          limit of Bis(4-sulfobutyl) ether disodium

          NMT 0.05%

          Bacterial Endotoxins Test

          10EU/g

          Microbial Enumeration Tests

          The total aerobic microbial count

          NMT 100cfu/g

          The total combined molds and yeasts count

          NMT 50cfu/g

          Tests for Specified Microorganisms

          Absence of Escherichia Coli/1g

          Clarity of Solution(30%,w/v)

          The solution is clear, and essentially free from particles of foreign matter

          Average Degree of Substitution

          6.2-6.9

          Ether Sodium Peaks I-X

          Limit Range(%Peak Area)

          I

          0-0.3

          II

          0-0.9

          III

          0.5-5.0

          IV

          2.0-10.0

          V

          10.0-20.0

          VI

          15.0-25.0

          20.0-30.0

          10.0-25.0

          2.0-12.0

          0-4.0

          pH

          4.0-6.8

          Water Determination

          NMT 10%


          Xi'an DELI Biochemical Industry Co.,Ltd.

          Tel: +86-29 87860211

          E-mail: xadl@xadl.com

          Add: 9 Lifeng road, Daixin Industrial Park Lintong District Xi'an, Shaanxi Province, China


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