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  • Impurezas Ezetimibe Ene-31-20

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    This document contains the results of several chromatography analyses performed by Laboratorio Farbroquim S.A.S. on January 31, 2020 using an HPLC MP-14 system. The first analysis detected ezetimibe at 2.35 minutes in a 0.1 mg/mL standard sample. The second analysis detected ezetimibe at 2.37 minutes in a 0.2 mg/mL sample. The third analysis detected a small ezetimibe peak at 3.01 minutes in a THF sample. The final analysis did not detect any peaks in a mobile phase sample.

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    IMPUREZAS EZETIMIBE ENE-31-20

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    This document contains the results of several chromatography analyses performed by Laboratorio Farbroquim S.A.S. on January 31, 2020 using an HPLC MP-14 system. The first analysis detected ezetimibe at 2.35 minutes in a 0.1 mg/mL standard sample. The second analysis detected ezetimibe at 2.37 minutes in a 0.2 mg/mL sample. The third analysis detected a small ezetimibe peak at 3.01 minutes in a THF sample. The final analysis did not detect any peaks in a mobile phase sample.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    14 views10 pages

    Impurezas Ezetimibe Ene-31-20

    Uploaded by

    Brendapaez3
    This document contains the results of several chromatography analyses performed by Laboratorio Farbroquim S.A.S. on January 31, 2020 using an HPLC MP-14 system. The first analysis detected ezetimibe at 2.35 minutes in a 0.1 mg/mL standard sample. The second analysis detected ezetimibe at 2.37 minutes in a 0.2 mg/mL sample. The third analysis detected a small ezetimibe peak at 3.01 minutes in a THF sample. The final analysis did not detect any peaks in a mobile phase sample.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 10

    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 10:13
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: STD1
    Sample Name: SST 0.1 mg/mL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.832.35

    0.05
    2.75
    2.93
    3.92
    3.52
    3.65
    3.71
    3.17

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    1 2.35 EZETIMIBE 471560 BB

    471560

    Peak rejection level: 0


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

    2.35 EZETIMIBE 233.67 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.35 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 Andrea Merchán S.

    Page Indicator 1 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 11:08
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: STD1
    Sample Name: MTA 0,2 mg/ mL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.37

    0.05
    3.57
    2.72
    2.96
    3.17

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    1 2.37 EZETIMIBE 405140 BB

    405140

    Peak rejection level: 0


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

    2.37 EZETIMIBE 236.33 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.37 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 Andrea Merchán S.

    Page Indicator 2 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 11:39
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: THF Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.03 2.24

    0.05
    3.52
    3.25
    2.88
    3.01

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    4 3.01 EZETIMIBE 115 TBV

    115

    Peak rejection level: 0


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

    3.01 EZETIMIBE 300.33 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3.01 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 Andrea Merchán S.

    Page Indicator 3 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 12:10
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: FASE MOVIL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10

    0.05
    2.29
    2.13
    3.55
    3.65
    2.51
    2.61
    2.69
    2.99
    3.07

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    6 2.99 EZETIMIBE 12087 VV

    12087

    Peak rejection level: 0


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

    2.99 EZETIMIBE 297.67 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.99 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 Andrea Merchán S.

    Page Indicator 4 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 12:46
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: STD1
    Sample Name: DILUENTE Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.692.32

    0.05
    3.07
    3.73
    3.89
    3.84
    2.85
    3.36

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    1 2.32 EZETIMIBE 581400 BB

    581400

    Peak rejection level: 0


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

    2.32 EZETIMIBE 231.00 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.32 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 Andrea Merchán S.

    Page Indicator 5 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 13:21
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: FASE MOVIL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10

    0.05
    2.29
    2.72
    2.53
    3.41
    3.49
    3.57
    3.07
    3.87

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    4 3.07 EZETIMIBE 42745 VV

    42745

    Peak rejection level: 0


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

    3.07 EZETIMIBE 305.67 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3.07 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 Andrea Merchán S.

    Page Indicator 6 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 15:01
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: DILUENTE Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.672.29

    0.05
    3.20
    3.36
    2.93
    3.01

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    4 3.01 EZETIMIBE 38955 VV

    38955

    Peak rejection level: 0


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

    3.01 EZETIMIBE 300.33 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3.01 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 Andrea Merchán S.

    Page Indicator 7 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 16:42
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: TETRAHIDROFURANO Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.21

    0.05
    2.96
    3.17
    3.33
    3.49
    3.55
    3.60
    3.73
    3.81

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    2 2.96 EZETIMIBE 443567 VV

    443567

    Peak rejection level: 0


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

    2.96 EZETIMIBE 295.00 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.96 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 Andrea Merchán S.

    Page Indicator 8 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 18:22
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: STD1
    Sample Name: ESTANDAR 0,1 mg/mL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.962.40

    0.05
    3.95
    2.80
    3.28

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    1 2.40 EZETIMIBE 448160 BB

    448160

    Peak rejection level: 0


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

    2.40 EZETIMIBE 239.00 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.40 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 Andrea Merchán S.

    Page Indicator 9 / 10
    D-7000 HSM: ENERO 2020 Series: 0029 System: HPLC MP-14

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 31/01/20 20:02
    Processing Method: EZETIMIBE ENE/31/20
    System(acquisition): HPLC MP-14 Vial Type: UNK
    Sample Name: MTA DUOLIP 10/20 0,2 mg/mL Volume: 30.0 ul
    Sample Description:
    N-Meth 0
    Inhib
    0.25 Sens 3

    0.20
    Absorbance (AU)

    0.15

    0.10
    2.32

    0.05
    3.23
    2.72
    3.73
    3.39
    2.99
    3.09
    3.55

    0.00

    -0.05

    0 10 20 30 40 50 60 70 80 90 100
    Retention Time (min)

    No. RT Name Area BC

    3 2.99 EZETIMIBE 120396 VV

    120396

    Peak rejection level: 0


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

    2.99 EZETIMIBE 297.67 --- --- ---

    RT Name Alpha S/N Noise


    (min) (uV)

    2.99 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 Andrea Merchán S.

    Page Indicator 10 / 10

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