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  • 3.2.P.8 Stability: (ENKORTEN - Lyophilisate and Solvent For Solution For Injection)

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    irmasa
    85 vizualizări3 pagini
    This document summarizes the stability testing for Enkorten, which contains the drug substances COM1 Acetate and COM2 Acetate. Three batches of Enkorten lyophilisate and solvent for injection were tested, consisting of 8500 vials each. The batches were manufactured and packaged by BAG Health Care GmbH. Stability testing was conducted under long term conditions of 5°C ± 3°C/60% RH and accelerated conditions of 25°C ± 2°C/60% RH. Samples were tested initially and at 0, 3, 6, 9, 12, 18, 24, and 36 months for the long term studies and 0, 3, and 6 months for the accelerated studies

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    This document summarizes the stability testing for Enkorten, which contains the drug substances COM1 Acetate and COM2 Acetate. Three batches of Enkorten lyophilisate and solvent for injection were tested, consisting of 8500 vials each. The batches were manufactured and packaged by BAG Health Care GmbH. Stability testing was conducted under long term conditions of 5°C ± 3°C/60% RH and accelerated conditions of 25°C ± 2°C/60% RH. Samples were tested initially and at 0, 3, 6, 9, 12, 18, 24, and 36 months for the long term studies and 0, 3, and 6 months for the accelerated studies

    Drepturi de autor:

    © All Rights Reserved
    Descărcați ca PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    85 vizualizări3 pagini

    3.2.P.8 Stability: (ENKORTEN - Lyophilisate and Solvent For Solution For Injection)

    Încărcat de

    irmasa
    This document summarizes the stability testing for Enkorten, which contains the drug substances COM1 Acetate and COM2 Acetate. Three batches of Enkorten lyophilisate and solvent for injection were tested, consisting of 8500 vials each. The batches were manufactured and packaged by BAG Health Care GmbH. Stability testing was conducted under long term conditions of 5°C ± 3°C/60% RH and accelerated conditions of 25°C ± 2°C/60% RH. Samples were tested initially and at 0, 3, 6, 9, 12, 18, 24, and 36 months for the long term studies and 0, 3, and 6 months for the accelerated studies

    Drepturi de autor:

    © All Rights Reserved
    Descărcați ca PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    din 3

    Name of Company:

    Name of Drug Product:


    Drug Substance:

    3.2.P.8

    FARMACIJA d.o.o.
    ENKORTEN
    COM1 Acetate, COM2 Acetate

    MODULE 3
    Page: 2
    Date: May 2009

    Stability
    (ENKORTEN Lyophilisate and Solvent for solution for injection)

    3.2.P.8.1.A

    I.

    Stability Summary and Conclusions - ENKORTEN

    Batches tested

    Batch number

    610602

    Batch type and batch size

    8500 vials
    PPL-COM10501A, PPL-COM20501R1
    PolyPeptide Laboratories, Inc.
    365 Maple Avenue, Torrance, CA 90503, USA
    6 March 2006
    BAG Health Care GmbH
    35424 Lich, Germany
    glass vial/rubber stopper
    09.03.2006 (long term stability studies)
    09.03.2006 (accelerated stability studies)
    16.04.2009 (long term stability studies)
    13.10.2006 (accelerated stability studies)

    API lot number,


    API manufacturer
    Date of manufacture
    Site of manufacture (site of packaging)
    Container
    Start of stability studies
    End of stability studies

    Batch number

    612601

    Batch type and batch size

    8500 vials
    PPL-COM10501A, PPL-COM20501R1
    PolyPeptide Laboratories, Inc.
    365 Maple Avenue, Torrance, CA 90503, USA
    6 March 2006
    BAG Health Care GmbH
    35424 Lich, Germany
    glass vial/rubber stopper
    30.03.2006 (long term stability studies)
    30.03.2006 (accelerated stability studies)
    16.04.2009 (long term stability studies)
    13.10.2006 (accelerated stability studies)

    API lot number,


    API manufacturer
    Date of manufacture
    Site of manufacture (site of packaging)
    Container
    Start of stability studies
    End of stability studies

    Name of Company:
    Name of Drug Product:
    Drug Substance:

    FARMACIJA d.o.o.
    ENKORTEN
    COM1 Acetate, COM2 Acetate

    MODULE 3
    Page: 3
    Date: May 2009

    Batch number

    613601

    Batch type and batch size

    8500 vials
    PPL-COM10501A, PPL-COM20501R1
    PolyPeptide Laboratories, Inc.
    365 Maple Avenue, Torrance, CA 90503, USA
    6 March 2006
    BAG Health Care GmbH
    35424 Lich, Germany
    glass vial/rubber stopper
    10.04.2006 (long term stability studies)
    10.04.2006 (accelerated stability studies)
    16.04.2009 (long term stability studies)
    13.10.2006 (accelerated stability studies)

    API lot number,


    API manufacturer
    Date of manufacture
    Site of manufacture (site of packaging)
    Container
    Start of stability studies
    End of stability studies

    Name of Company:
    Name of Drug Product:
    Drug Substance:

    II

    MODULE 3
    Page: 4
    Date: May 2009

    Storage conditions and testing frequency ENKORTEN


    Temperature [oC]
    +5 3
    +25 2

    III

    FARMACIJA d.o.o.
    ENKORTEN
    COM1 Acetate, COM2 Acetate

    Relative humidity RH [%] Testing frequency [months]


    0, 3, 6, 9, 12, 18, 24, 36
    0, 3, 6
    60 5

    Packaging material ENKORTEN

    Primary packaging material


    Glass vials / rubber cap (See section "3.2.P.7 Container Closure System").

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