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    3.2.S.4.4 COA of Azithromycin API HPLC Chromatogram

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    Muhammad Imran
    The document contains four chromatograms from an HPLC analysis of the drug azithromycin dihydrate conducted by Wenovo Pharmaceuticals. Each chromatogram shows a single peak at a retention time of 0.854-0.855 minutes identified as azithromycin. The peak areas and other parameters are consistent across the four runs, indicating the method is producing reproducible results.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    3.2.S.4.4 COA of Azithromycin API HPLC Chromatogram

    Uploaded by

    Muhammad Imran
    25 views7 pages
    The document contains four chromatograms from an HPLC analysis of the drug azithromycin dihydrate conducted by Wenovo Pharmaceuticals. Each chromatogram shows a single peak at a retention time of 0.854-0.855 minutes identified as azithromycin. The peak areas and other parameters are consistent across the four runs, indicating the method is producing reproducible results.

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    3.2.S.4.4 COA of Azithromycin API HPLC chromatogram

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    The document contains four chromatograms from an HPLC analysis of the drug azithromycin dihydrate conducted by Wenovo Pharmaceuticals. Each chromatogram shows a single peak at a retention time of 0.854-0.855 minutes identified as azithromycin. The peak areas and other parameters are consistent across the four runs, indicating the method is producing reproducible results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    25 views7 pages

    3.2.S.4.4 COA of Azithromycin API HPLC Chromatogram

    Uploaded by

    Muhammad Imran
    The document contains four chromatograms from an HPLC analysis of the drug azithromycin dihydrate conducted by Wenovo Pharmaceuticals. Each chromatogram shows a single peak at a retention time of 0.854-0.855 minutes identified as azithromycin. The peak areas and other parameters are consistent across the four runs, indicating the method is producing reproducible results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 7

    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************
    Sample Information Sample Information
    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:23:35 AM
    Sample ID : Standard-Replicate-01 Data File : Data058.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-058-1 –Data058.lcd

    350
    1 PDA Multi 1 210nm,4nm

    Azithromycin
    300

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.855 Azithromycin 1684132.893 296271.149 800241
    Total 1684132.893 296271.149

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.223 -- -- 213.954 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************
    Sample Information Sample Information
    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:25:05 AM
    Sample ID : Standard-Replicate-02 Data File : Data059.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-059-1 –Data059.lcd

    350
    1 PDA Multi 1 210nm,4nm

    Azithromycin
    300

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.855 Azithromycin 1703743.205 295812.814 800237
    Total 1703743.205 295812.814

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.225 -- -- 212.454 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************

    Sample Information Sample Information


    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:26:35 AM
    Sample ID : Standard-Replicate-03 Data File : Data060.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-060-1 –Data060.lcd

    350
    1 PDA Multi 1 210nm,4nm

    Azithromycin
    300

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.854 Azithromycin 1699794.908 295218.762 800232
    Total 1699794.908 295218.762

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.224 -- -- 212.960 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************

    Sample Information Sample Information


    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:28:05 AM
    Sample ID : B#115-230124-1-Replicate-01 Data File : Data061.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-061-1 –Data061.lcd

    350
    1 PDA Multi 1 210nm,4nm

    Azithromycin
    300

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.853 Azithromycin 1700030.154 298532.859 800228
    Total 1700030.154 298532.859

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.227 -- -- 213.581 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************

    Sample Information Sample Information


    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:29:35 AM
    Sample ID : B#115-230124-1-Replicate-02 Data File : Data062.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-062-1 –Data062.lcd

    350
    1 PDA Multi 1 210nm,4nm

    Azithromycin
    300

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.856 Azithromycin 1692322.304 289532.483 800223
    Total 1692322.304 289532.483

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.231 -- -- 213.830 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************

    Sample Information Sample Information


    Sample Name : Azithromycin Dihydrate Date Acquired : 07/09/2020 11:31:05 AM
    Sample ID : B#115-230124-1-Replicate-03 Data File : Data063.lcd
    Processed by : Ahmad

    ******************************************************************
    mAU Chromatogram
    Azithromycin - 1-21/1-063-1 –Data063.lcd

    350
    1 PDA Multi 1 210nm,4nm

    300 Azithromycin

    250

    200

    150

    100

    50

    -50

    0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 min
    Peak Table
    PDA Ch1 210nm
    Peak# Ret. Time Name Area Height Theoretical Plates/meter(USP)
    1 0.856 Azithromycin 1701154.499 293518.497 800219
    Total 1701154.499 293518.497

    Tailing Factor Capacity Factor(k') Peak Valley Ratio HETP(USP) Area%

    1.230 -- -- 212.549 100.000


    100.000

    Page 1 of 1
    WENOVO PHARMACEUTICALS

    ********* HPLC CHROMATOGRAM*********


    Instrument ID # WNP-QC-INS-059

    ******************************************************************

    Page 1 of 1

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