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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



        Stella sales manager                    Jessie sales manager                    Fiona sales manager

        Tel: +86 13629288591                  Tel: +86 18082495415                   Tel: +86 13609260206

        E-mail: stella@xadl.com               E-mail: jimmy@xadl.com               E-mail: fiona@xadl.com

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