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  • ENSAYO DUOLIOP IMPUREZAS SIMVASTATINAa

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    The document summarizes the results of an HPLC analysis of several samples including mobile phase, diluent, and placebo formulations. The analysis was performed on January 27, 2020 using a specified method. Chromatograms and results are shown for each sample, including retention times and peak areas. The analysis was developed by Angela Garcia and analyzed by Laura Merchan.

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    The document summarizes the results of an HPLC analysis of several samples including mobile phase, diluent, and placebo formulations. The analysis was performed on January 27, 2020 using a specified method. Chromatograms and results are shown for each sample, including retention times and peak areas. The analysis was developed by Angela Garcia and analyzed by Laura Merchan.

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    © All Rights Reserved
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    28 views10 pages

    ENSAYO DUOLIOP IMPUREZAS SIMVASTATINAa

    Uploaded by

    Brendapaez3
    The document summarizes the results of an HPLC analysis of several samples including mobile phase, diluent, and placebo formulations. The analysis was performed on January 27, 2020 using a specified method. Chromatograms and results are shown for each sample, including retention times and peak areas. The analysis was developed by Angela Garcia and analyzed by Laura Merchan.

    Copyright:

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

    LABORATORIO FARBROQUIM S.A.

    S
    Analyzed Date and time: 27/01/2020 04:34:47 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\001.FASE MOVIL.dat
    System (acquisition): HPLC (Offline)
    Sample Name: FASE MOVIL Injection Volume: 20 uL
    Sample Description: BLANCO

    DAD-CH1 238 nm
    FASE MOVIL
    001.FASE MOVIL.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO TENIVASTATINA
    Totals

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (1)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 27/01/2020 06:15:06 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\002.DILUENTE.dat
    System (acquisition): HPLC (Offline)
    Sample Name: DILUENTE Injection Volume: 20 uL
    Sample Description: BLANCO

    DAD-CH1 238 nm
    DILUENTE
    002.DILUENTE.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO TENIVASTATINA
    Totals

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (2)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 27/01/2020 07:55:26 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\003.PLACEBO INDUSTRIAL.dat
    System (acquisition): HPLC (Offline)
    Sample Name: PLACEBO INDUSTRIAL Injection Volume: 20 uL
    Sample Description: BLANCO

    DAD-CH1 238 nm
    PLACEBO INDUSTRIAL
    003.PLACEBO INDUSTRIAL.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO TENIVASTATINA
    Totals

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (3)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 27/01/2020 09:35:37 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\004.PLACEBO REFORMULADO.dat
    System (acquisition): HPLC (Offline)
    Sample Name: PLACEBO REFORMULADO Injection Volume: 20 uL
    Sample Description: BLANCO

    DAD-CH1 238 nm
    PLACEBO REFORMULADO
    004.PLACEBO REFORMULADO.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO TENIVASTATINA
    Totals

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    SIMVASTATINA
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (4)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 09:17:34 a.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\012.ESTANDAR SST.dat
    System (acquisition): HPLC (Offline)
    Sample Name: ESTANDAR SST Injection Volume: 20 uL
    Sample Description: ESTANDAR

    DAD-CH1 238 nm
    ESTANDAR SST
    012.ESTANDAR SST.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    38,20 SIMVASTATINA

    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    1 38,20 SIMVASTATINA 2649806
    ÉSTER METÍLICO TENIVASTATINA
    Totals
    2649806

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    38,20 SIMVASTATINA 7237 1,02 0,00 126,33
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (5)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 10:57:53 a.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\013.ESTANDAR SST 0.2 mg mL.dat
    System (acquisition): HPLC (Offline)
    Sample Name: ESTANDAR SST 0.2 mg mL Injection Volume: 20 uL
    Sample Description: ESTANDAR

    DAD-CH1 238 nm

    39,24 SIMVASTATINA
    ESTANDAR SST 0.2 mg mL
    013.ESTANDAR SST 0.2 mg mL.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    TENIVASTATINA
    1 39,24 SIMVASTATINA 20830574
    ÉSTER METÍLICO TENIVASTATINA
    Totals
    20830574

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    TENIVASTATINA
    39,24 SIMVASTATINA 8590 1,01 0,00 129,80
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (6)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 12:38:14 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\014.SOLUCION ESTANDAR.dat
    System (acquisition): HPLC (Offline)
    Sample Name: SOLUCION ESTANDAR Injection Volume: 20 uL
    Sample Description: ESTANDAR

    DAD-CH1 238 nm
    SOLUCION ESTANDAR
    014.SOLUCION ESTANDAR.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    18,53 TENIVASTATINA

    39,40 SIMVASTATINA

    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    1 18,53 TENIVASTATINA 1847852
    2 39,40 SIMVASTATINA 961508
    ÉSTER METÍLICO TENIVASTATINA
    Totals
    2809360

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    18,53 TENIVASTATINA 8284 1,03 0,00 60,78
    39,40 SIMVASTATINA 9546 0,95 17,19 130,33
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (7)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 02:18:33 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\015.SOLUCION ESTANDAR.dat
    System (acquisition): HPLC (Offline)
    Sample Name: SOLUCION ESTANDAR Injection Volume: 20 uL
    Sample Description: ESTANDAR

    DAD-CH1 238 nm
    SOLUCION ESTANDAR
    015.SOLUCION ESTANDAR.dat
    125 Retention Time 125
    Name

    100 100

    75 75
    mAU

    mAU
    19,45 TENIVASTATINA

    40,91 SIMVASTATINA

    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    1 19,45 TENIVASTATINA 1857758
    2 40,91 SIMVASTATINA 1077265
    ÉSTER METÍLICO TENIVASTATINA
    Totals
    2935023

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    19,45 TENIVASTATINA 8053 1,02 0,00 63,84
    40,91 SIMVASTATINA 72520 0,88 29,09 135,36
    ÉSTER METÍLICO
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (8)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 03:58:51 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\016.MUESTRA LOTE INDUSTRIAL.dat
    System (acquisition): HPLC (Offline)
    Sample Name: MUESTRA LOTE INDUSTRIAL Injection Volume: 20 uL
    Sample Description: DUOLIP 10/20 mg TABLETA

    DAD-CH1 238 nm
    MUESTRA LOTE INDUSTRIAL
    016.MUESTRA LOTE INDUSTRIAL.dat
    125 Retention Time 125

    46,27 ÉSTER METÍLICO TENIVASTATINA


    Name
    19,48 TENIVASTATINA

    100 100

    75 75
    mAU

    mAU
    40,83 SIMVASTATINA

    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    1 19,48 TENIVASTATINA 6381226
    2 40,83 SIMVASTATINA 125315412
    3 46,27 ÉSTER METÍLICO TENIVASTATINA 127485
    Totals
    131824123

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    19,48 TENIVASTATINA 8070 1,01 0,00 63,93
    40,83 SIMVASTATINA 57991 0,94 27,62 135,09
    46,27 ÉSTER METÍLICO 129824 1,03 9,13 153,22
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (9)
    LABORATORIO FARBROQUIM S.A.S
    Analyzed Date and time: 28/01/2020 05:39:09 p.m.
    Processing Method: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Method\SIMVASTATINA ENE-27-20.met
    Data File Name: C:\EZChrom Elite\Enterprise\Projects\DATOS2019\HPLC MP-13\ENERO
    2020\Data\SIMVASTATIANA ENE-27-20\017.MUESTRA LOTE REFORMULADO.dat
    System (acquisition): HPLC (Offline)
    Sample Name: MUESTRA LOTE REFORMULADO Injection Volume: 20 uL
    Sample Description: DUOLIP 10/20 mg TABLETA

    DAD-CH1 238 nm
    MUESTRA LOTE REFORMULADO
    017.MUESTRA LOTE REFORMULADO.dat
    125 Retention Time 125
    Name

    46,35 ÉSTER METÍLICO TENIVASTATINA


    100 100
    19,56 TENIVASTATINA

    75 75
    mAU

    mAU
    40,95 SIMVASTATINA

    50 50

    25 25

    0 0

    0 10 20 30 40 50 60 70 80 90
    Minutes

    DAD-CH1 238 nm
    Results
    Pk # Retention Time Name Area
    1 19,56 TENIVASTATINA 6481161
    2 40,95 SIMVASTATINA 136852471
    3 46,35 ÉSTER METÍLICO TENIVASTATINA 946665
    Totals
    144280297

    DAD-CH1
    238 nm
    Results
    Retention Name Theoretical Asymmetry Resolution Capacity
    Time plates (USP) factor
    (USP)
    19,56 TENIVASTATINA 7990 1,05 0,00 64,20
    40,95 SIMVASTATINA 75257 0,94 29,05 135,49
    46,35 ÉSTER METÍLICO 126965 0,97 9,67 153,49
    TENIVASTATINA

    Developed By: ANGELA GARCIA Analized By: LAURA MERCHAN

    Page 1 of 1 (10)

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