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    COA - Cyclopentolate HCL

    Uploaded by

    Lucas de Melo Goncalves Pereira

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    © All Rights Reserved
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    COA - Cyclopentolate HCL

    Uploaded by

    Lucas de Melo Goncalves Pereira
    11 views1 page

    Original Title

    COA -Cyclopentolate Hcl

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    11 views1 page

    COA - Cyclopentolate HCL

    Uploaded by

    Lucas de Melo Goncalves Pereira

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    HEALTH BIOCHEM TECHNOLOGY CO.

    ,LTD
    Add:Li Jing Jia Yuan, Wei Qu Xi Jie, Chang'an District,Xi'an,China 710010
    Skype: andyandy85121 Email: [email protected] Tel: 0086-18049663452

    Certificate Of Analysis
    Product name Cyclopentolate Hcl

    Batch No. HB20230711 Batch quantity 50kg

    Mfg.date 11th.07,2023 Retest date 11th.07,2025

    Items Specification Results


    white crystalline powder
    White or almost white crystalline powder Very
    Characters Very soluble in water,freely
    soluble in water,freely soluble in alcohol (96%)
    soluble in alcohol (96%)
    IR spectrum concordant with
    By IR: IR spectrum should be concordant with
    spectrum of Cyclopentolate
    spectrum of Cyclopentolate Hydrochloride CRS.
    Identification Hydrochloride CRS.
    Chlorides:Positive reaction of chlorides
    Positive

    PH(1% solution) 4.5 to 5.5 5.10

    Impurity A NMT 0.10% < 0.002%


    Impurity B NMT 0.10% < 0.017%
    Related substances
    Impurity C NMT 0.5% 0.18%
    (By HPLC)
    Unknown single Impurity NMT 0.10% < 0.004%
    Total Impurity NMT 1.0% 0.18%

    Loss on drying NMT 0.5% 0.19%

    Sulphated ash NMT 0.1% 0.02%

    Acetone Max.5000 ppm 3038.8ppm


    Residual Solvents 2-Propanol Max.5000 ppm 407.1ppm
    (By GCHS)
    Cyclopentanone Max.1000ppm 517.8ppm

    NLT 98.5%&NMT 101.5% calculated with reference


    Assay ( By titration ) 100.17%
    to the dried substance

    Conclusion: The product complies with EP 9.0Standard

    Inspector: Analyst:

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