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      HOME > PRODUCT > PHARMACEUTICAL EXCIPIENTS & FOOD ADDITIVES

        Hydroxypropyl beta cyclodextrin

        Appearance: White powder,Non-toxic CAS No: 128446-35-5 Specs: Food,Pharma,Cosmetic Molecular Formula: C56H98O42 Package: 500g/bag , 2kg/bag,10kg/carton ,20kg/drum Applications: increase solubility, reduce side effect,stabilizer



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        1. Detailed information

        Appearance:  White powder,Non-toxic

        CAS No:  128446-35-5

        Specs:  Food,Pharma,Cosmetic

        Molecular Formula:  C56H98O42

        Package: 500g/bag , 2kg/bag,10kg/carton ,20kg/drum

        Applications:  increase solubility,

        reduce side effect,stabilizer


        CAS No.:  128446-35-5

        BatchNo.

        20150503

        Packing

        10kg/drum

        Manufacturingdate

        2015.05.03

        Quantity

        2514.3kgs

        SamplingTime

        2015.05.13

        ReportDate

        2015.05.18

        SampleFrom

        Cleaningroom

        ExpiryDate

        2017.05.02

        TestStandard

        USP38-NF33

        ITEMS

        SPECIFICATION

        RESULTS

        Appearance

        Whitepowder, insipid, innocent

        Qualify

        Degreeof Substitution

        2.8-10.5

        5.3

        Clarityof solution

        50%(w/v)watersolution is clear

        clear

        Identification(IR)

        Sameabsorption bands with USP Hydroxypropyl betadex RS

        Qualify

        Losson Drying

        ≤10%

        4.00%

        Conductivity

        10%(w/v)watersolution ≤200μS/cm

        132

        Propyleneoxide

        ≤1ppm

        <0.18ppm

        Propyleneglycol

        ≤2.5%

        0.12%

        Sumof Other Impurities

        ≤1%

        0.51%

        Betadex

        ≤1.5%

        0.12%

        Residueon Ignition

        ≤0.2%

        0.07%

        Heavymetal

        ≤20ppm

        <10ppm

        chloride

        ≤0.05%

        <0.05%

        TAMC(CFU/g)

        ≤1000

        30

        TYMC(CFU/g)

        ≤100

        10

        Salmonella/E.Coli (CFU/g)

        Absent

        Absent

        Conclusion: According tostandards of USP38-NF33,the product is Qualified.
        Note: Test result sameas co-shipment sample batch inspection report

         


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