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  • Impurezas Ezetimibe Ene-29-20

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    Brendapaez3
    7 views9 pages
    This document contains chromatograms from an analysis of ezetimibe samples using HPLC. Three chromatograms show a mobile phase, diluent, and sensitivity standard. Two additional chromatograms show standards of 0.1 mg/mL ezetimibe with peak areas of around 6.6 million and retention times of 10.06-10.07 minutes. Warnings are given about the symmetry, number of plates, resolution, and signal-to-noise ratio of the peaks.

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    IMPUREZAS EZETIMIBE ENE-29-20

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    This document contains chromatograms from an analysis of ezetimibe samples using HPLC. Three chromatograms show a mobile phase, diluent, and sensitivity standard. Two additional chromatograms show standards of 0.1 mg/mL ezetimibe with peak areas of around 6.6 million and retention times of 10.06-10.07 minutes. Warnings are given about the symmetry, number of plates, resolution, and signal-to-noise ratio of the peaks.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    7 views9 pages

    Impurezas Ezetimibe Ene-29-20

    Uploaded by

    Brendapaez3
    This document contains chromatograms from an analysis of ezetimibe samples using HPLC. Three chromatograms show a mobile phase, diluent, and sensitivity standard. Two additional chromatograms show standards of 0.1 mg/mL ezetimibe with peak areas of around 6.6 million and retention times of 10.06-10.07 minutes. Warnings are given about the symmetry, number of plates, resolution, and signal-to-noise ratio of the peaks.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 9

    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 12:01
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: FASE MOVIL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    Peak rejection level: 0


    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 1 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 12:22
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: DILUENTE Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    Peak rejection level: 0


    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 2 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 12:43
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR SENSIBILIDAD Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    Peak rejection level: 0


    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 3 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 14:27
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: STD1
    Sample Name: ESTANDAR 0,1 mg/mL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    10,07, EZETIMIBE
    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    1 10,07 EZETIMIBE 6623244 BB

    6623244

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    10,07 EZETIMIBE 1006,33 1,01 648 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    10,07 EZETIMIBE --- 1,40* 156358,00

    WARNING: Criterion for S/N Ratio not satisfied.


    Asymmetry warning outside the range of: 0,800 to 2,000
    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 4 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 14:43
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: STD1
    Sample Name: ESTANDAR 0,1 mg/mL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    10,06, EZETIMIBE
    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    1 10,06 EZETIMIBE 6488138 BB

    6488138

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    10,06 EZETIMIBE 1005,00 1,09 521 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    10,06 EZETIMIBE --- 1,27* 156358,00

    WARNING: Criterion for S/N Ratio not satisfied.


    Asymmetry warning outside the range of: 0,800 to 2,000
    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 5 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 14:59
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR 0,001 mg / mL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    9,93, EZETIMIBE
    200
    Intensity (mV)

    150

    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    1 9,93 EZETIMIBE 6594164 BB

    6594164

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    9,93 EZETIMIBE 992,33 1,02 556 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    9,93 EZETIMIBE --- 1,32* 156358,00

    WARNING: Criterion for S/N Ratio not satisfied.


    Asymmetry warning outside the range of: 0,800 to 2,000
    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 6 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 15:15
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR 0,001 mg / mL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    10,21, EZETIMIBE
    100

    50

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    1 10,21 EZETIMIBE 5174 BB

    5174

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    10,21 EZETIMIBE 1020,33 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    10,21 EZETIMIBE --- 0,00* 154463,00

    WARNING: Criterion for S/N Ratio not satisfied.


    Asymmetry warning outside the range of: 0,800 to 2,000
    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 7 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 15:31
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: STD1
    Sample Name: ESTANDAR 0,01 mg / mL Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    100

    50 9,76, EZETIMIBE

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    1 9,76 EZETIMIBE 57572 BB

    57572

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    9,76 EZETIMIBE 975,00 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    9,76 EZETIMIBE --- --- ---

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 8 / 9
    D-7000 HSM: ENERO 2020 Series: 0044 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 30/01/20 15:57
    Processing Method: EZETIMIBA ENE/29/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: MTA DUOLIP Volume: 30,0 ul
    Sample Description:
    N-Meth 0
    250 Inhib Inhib
    Sens 8

    200
    Intensity (mV)

    150

    100

    9,95, EZETIMIBE
    50

    11,51
    10,91
    8,18

    8,96

    0 2 4 6 8 10 12 14 16 18
    Retention Time (min)

    No. RT Name Area BC

    3 9,95 EZETIMIBE 3949 BB

    3949

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    9,95 EZETIMIBE 994,33 1,12 --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    9,95 EZETIMIBE --- 0,00* 154405,00

    WARNING: Criterion for S/N Ratio not satisfied.


    Asymmetry warning outside the range of: 0,800 to 2,000
    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado por: LAURA MERCHAN

    Page Indicator 9 / 9

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