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  • M Lote LP Lef 19 002 N D

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    This document contains the results of an analysis of betahistine dihydrochloride using an MP-15 instrument. The analysis failed the peak asymmetry test for all injections due to values below 1. The document provides chromatograms and test results for 4 injections of a sample.

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    M LOTE LP LEF 19 002 N D

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    This document contains the results of an analysis of betahistine dihydrochloride using an MP-15 instrument. The analysis failed the peak asymmetry test for all injections due to values below 1. The document provides chromatograms and test results for 4 injections of a sample.

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    © All Rights Reserved
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    17 views6 pages

    M Lote LP Lef 19 002 N D

    Uploaded by

    Brendapaez3
    This document contains the results of an analysis of betahistine dihydrochloride using an MP-15 instrument. The analysis failed the peak asymmetry test for all injections due to values below 1. The document provides chromatograms and test results for 4 injections of a sample.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 6

    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 1 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 03:30
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 03:30 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.68 BETAHISTINA 2HCl 3.363
    Total: 3.363

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D1 LOTE LP-LEF-19-002 4156.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 6 LOTE LP-LEF-19-00 0.923
    BETAHISTINA 2HCl 1 LOTE LP-LEF-19-00 0.944
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 1 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 1 LOTE LP-LEF-19-00 0.023
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks NA -> Passed 1 LOTE LP-LEF-19-00 n.a.
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925
    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 2 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 03:51
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 03:51 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.68 BETAHISTINA 2HCl 3.290
    Total: 3.290

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D2 LOTE LP-LEF-19-002 3903.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 1 LOTE LP-LEF-19-00 0.944
    BETAHISTINA 2HCl 2 LOTE LP-LEF-19-00 0.919
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 2 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 2 LOTE LP-LEF-19-00 0.022
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks Passed 2 LOTE LP-LEF-19-00 1093.091
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925
    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 3 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 04:12
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 04:12 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.68 BETAHISTINA 2HCl 3.399
    Total: 3.399

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D3 LOTE LP-LEF-19-002 4161.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 2 LOTE LP-LEF-19-00 0.919
    BETAHISTINA 2HCl 3 LOTE LP-LEF-19-00 0.931
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 3 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 3 LOTE LP-LEF-19-00 0.024
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks Passed 3 LOTE LP-LEF-19-00 827.108
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925
    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 4 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 04:33
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 04:33 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.70 BETAHISTINA 2HCl 3.382
    Total: 3.382

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D4 LOTE LP-LEF-19-002 4171.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 3 LOTE LP-LEF-19-00 0.931
    BETAHISTINA 2HCl 4 LOTE LP-LEF-19-00 0.922
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 4 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 4 LOTE LP-LEF-19-00 0.027
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks Passed 4 LOTE LP-LEF-19-00 1072.375
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925
    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 5 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 04:54
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 04:54 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.68 BETAHISTINA 2HCl 3.275
    Total: 3.275

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D5 LOTE LP-LEF-19-002 4132.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 4 LOTE LP-LEF-19-00 0.922
    BETAHISTINA 2HCl 5 LOTE LP-LEF-19-00 0.932
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 5 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 5 LOTE LP-LEF-19-00 0.018
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks Passed 5 LOTE LP-LEF-19-00 950.412
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925
    Instrument:MP-15 Sequence:BETAHISTINA DICLORHIDRATO AGO-31-20 Page 6 of 6

    LABORATORIO FARBROQUIM S.A.S


    Injection Date/Time: 01/Sep/20 05:15
    Processing Method: BETAHISTINA DICLORHIDRATO AGO-31-20
    Instrument name: MP-15 Injection Type: Unknown
    Injection Name: 01/Sep/2020 05:15 Injection Volume: 25.00
    Comment: LEFLUX 8 mg TAB EN T3 TRILAMINADO
    Directory: Instrument Data\MP-15\AGOSTO 2020

    Chromatogram

    No. Retention Time Peak Name Area


    min mAU*min
    1 5.68 BETAHISTINA 2HCl 3.379
    Total: 3.379

    SST Results
    No.
    Name Peak Name Peak Test Result Injection Inj. Eval. Result
    1 Theoretical Plates (USP) BETAHISTINA 2HCl All Identified Peaks Passed D6 LOTE LP-LEF-19-002 4027.000
    2 Peak Asymmetry BETAHISTINA 2HCl All Identified Peaks Failed 5 LOTE LP-LEF-19-00 0.932
    BETAHISTINA 2HCl 6 LOTE LP-LEF-19-00 0.924
    3 Resolution (USP) BETAHISTINA 2HCl All Identified Peaks NA -> Passed 6 LOTE LP-LEF-19-00 n.a.
    4 Signal Noise n.a. Passed 6 LOTE LP-LEF-19-00 0.027
    5 Signal / Noise Ratio BETAHISTINA 2HCl All Identified Peaks Passed 6 LOTE LP-LEF-19-00 507.866
    Number of executed test cases: 5 Total Result: Failed

    Método creado por: Angela Garcia Analizado por: Lady Martinez

    Chromeleon (c) Dionex


    BETAHISTINA DICLORHIDRATO AGO-31-20/Integration Version 7.2.10.23925

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