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    This document contains the results of three analyses of an ibundronate sodium standard sample using HPLC. The sample was detected at a retention time of approximately 3.28 minutes in each run. Peak areas were in the range of 421794 to 428755 for ibundronate sodium. Various method parameters are reported, with some values outside specified ranges for asymmetry, theoretical plates and signal to noise ratio. The analyses were performed on different dates and times to test the ibundronate sodium standard.

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    SUSTANCIAS RELACIONADAS

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    This document contains the results of three analyses of an ibundronate sodium standard sample using HPLC. The sample was detected at a retention time of approximately 3.28 minutes in each run. Peak areas were in the range of 421794 to 428755 for ibundronate sodium. Various method parameters are reported, with some values outside specified ranges for asymmetry, theoretical plates and signal to noise ratio. The analyses were performed on different dates and times to test the ibundronate sodium standard.

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    © All Rights Reserved
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    19 views6 pages

    Sustancias Relacionadas

    Uploaded by

    Brendapaez3
    This document contains the results of three analyses of an ibundronate sodium standard sample using HPLC. The sample was detected at a retention time of approximately 3.28 minutes in each run. Peak areas were in the range of 421794 to 428755 for ibundronate sodium. Various method parameters are reported, with some values outside specified ranges for asymmetry, theoretical plates and signal to noise ratio. The analyses were performed on different dates and times to test the ibundronate sodium standard.

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    © All Rights Reserved
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    of 6

    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 03:19 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR Volume: 20,0 ul
    Sample Description:

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,35

    100
    1500
    0
    Intensity (mV)

    3,35, IBANDRONATO DE SODIO

    0 2 4 6 8

    1000

    500

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

    No. RT Name Area BC

    1 3,35 IBANDRONATO DE SODIO 421794 BB

    421794

    Peak rejection level: 0


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

    3,35 IBANDRONATO DE SODIO 334,00 1,64 4047 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,35 IBANDRONATO DE SODIO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 1 / 5
    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 03:40 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR Volume: 20,0 ul
    Sample Description:

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,27

    100
    1500
    0
    Intensity (mV)

    3,35, IBANDRONATO DE SODIO

    0 2 4 6 8

    1000

    500

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

    No. RT Name Area BC

    1 3,27 IBANDRONATO DE SODIO 424899 BB

    424899

    Peak rejection level: 0


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

    3,27 IBANDRONATO DE SODIO 326,33 1,33 3490 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,27 IBANDRONATO DE SODIO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 2 / 5
    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 04:01 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR Volume: 20,0 ul
    Sample Description:

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,28

    100
    1500
    0
    Intensity (mV)

    3,28, IBANDRONATO DE SODIO

    0 2 4 6 8

    1000

    500

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

    No. RT Name Area BC

    1 3,28 IBANDRONATO DE SODIO 428755 BB

    428755

    Peak rejection level: 0


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

    3,28 IBANDRONATO DE SODIO 327,33 1,04 3722 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,28 IBANDRONATO DE SODIO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 3 / 5
    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 04:19 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR Volume: 20,0 ul
    Sample Description:

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,31

    100
    1500
    0
    Intensity (mV)

    3,31, IBANDRONATO DE SODIO

    0 2 4 6 8

    1000

    500

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

    No. RT Name Area BC

    1 3,31 IBANDRONATO DE SODIO 424506 BB

    424506

    Peak rejection level: 0


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

    3,31 IBANDRONATO DE SODIO 330,33 1,41 4063 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,31 IBANDRONATO DE SODIO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 4 / 5
    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 04:28 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: ESTANDAR Volume: 20,0 ul
    Sample Description:

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,36

    100
    1500
    0
    Intensity (mV)

    3,36, IBANDRONATO DE SODIO

    0 2 4 6 8

    1000

    500

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

    No. RT Name Area BC

    1 3,36 IBANDRONATO DE SODIO 428662 BB

    428662

    Peak rejection level: 0


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

    3,36 IBANDRONATO DE SODIO 335,00 1,42 4020 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,36 IBANDRONATO DE SODIO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 5 / 5
    D-7000 HSM: MAYO 2020 Series: 0007 System: OFFLINE

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/05/20 04:50 p.m.
    Processing Method: ACIDO IBANDRONICO MAY/07/20
    System(acquisition): HPLC MP-07 Vial Type: UNK
    Sample Name: MTA LOTE 163063 Volume: 20,0 ul
    Sample Description: IBANAT 150mg TABLETAS

    300
    N-Meth 0
    Inhib Inhib
    200
    Sens 20
    3,58

    100
    1500
    0
    Intensity (mV)

    0 2 4 6 8
    3,58, ACIDO IBANTRONICO

    1000

    500

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

    No. RT Name Area BC

    1 3,58 ACIDO IBANTRONICO 473182 BB

    473182

    Peak rejection level: 0


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

    3,58 ACIDO IBANTRONICO 357,33 1,28 3871 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    3,58 ACIDO IBANTRONICO --- --- ---

    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: BRENDA CHINGATE

    Page Indicator 1 / 1

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