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  • Cetrizine Impurity D COA

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    1) This certificate of analysis is for a batch of Cetrizine Dimer (impurity D) with a catalog code number of 1032104 and batch number L1204NN. 2) Analysis on December 22, 2014 showed the product was an off-white solid that is freely soluble in methanol and confirmed to be Cetrizine Dimer through 1H NMR, mass spectrometry, and HPLC purity testing at 98.56%. 3) The product should be preserved in an air-tight container and protected from direct sunlight, with a retest date of December 2016.

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    SS Bioanalytics gives certified impurity standards

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    1) This certificate of analysis is for a batch of Cetrizine Dimer (impurity D) with a catalog code number of 1032104 and batch number L1204NN. 2) Analysis on December 22, 2014 showed the product was an off-white solid that is freely soluble in methanol and confirmed to be Cetrizine Dimer through 1H NMR, mass spectrometry, and HPLC purity testing at 98.56%. 3) The product should be preserved in an air-tight container and protected from direct sunlight, with a retest date of December 2016.

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    © All Rights Reserved
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    33 views2 pages

    Cetrizine Impurity D COA

    Uploaded by

    ssbioanalytics
    1) This certificate of analysis is for a batch of Cetrizine Dimer (impurity D) with a catalog code number of 1032104 and batch number L1204NN. 2) Analysis on December 22, 2014 showed the product was an off-white solid that is freely soluble in methanol and confirmed to be Cetrizine Dimer through 1H NMR, mass spectrometry, and HPLC purity testing at 98.56%. 3) The product should be preserved in an air-tight container and protected from direct sunlight, with a retest date of December 2016.

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    © All Rights Reserved
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    of 2

    CERTIFICATE OF ANALYSIS

    CETRIZINE DIMER( IMPURITY D)


    Catlog code No
    Product Name
    Chemical Name
    Mol. Formula
    Mol. Weight
    Batch No L1204NN

    Analysis Date

    Quantity 50 mg

    Retest Date

    Storage

    Preserve in Air tight container, protect from direct sunli

    S.N.

    Test

    Result

    Appearance

    off white solid

    Solubility

    Freely Soluble in Me

    Identification by 1H NMR

    Complies

    Identification by Mass

    Complies

    Purity by HPLC

    98.56%

    Remarks: Based on 1H NMR, Mass and HPLC data, material confir

    Prepared By

    Sign.
    Date:

    FRM/007-00

    1032104
    Cetrizine Dimer (impurity D)
    1,4-bis((4-chlorophenyl)(phenyl)methyl)piperazine
    C43H38Cl4N2
    487.46 g/mol
    22-Dec-14
    Dec-16
    sunlight and for longer storage store at 2-8 C.

    in Methanol

    confirms to the above product.

    Approved by

    Quality Control Department

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