Galenix Drug Delivery Solutions, Drug Product Development, Licencing-Out Opportunities

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Stability Studies


Stability studies are performed both on API and finished products in various packaging and climatic conditions.
Development, regulatory and on-going stability studies are managed in accordance with european and us FDA recommendations

  • galenix-innovations-climatic-storage

    Climatic Storage

    ICH standards :
    API’s, finished products, all types of containers, including semi-permeable containers
    Climatic zones I, II, III, IVa, IVb and miscellaneous conditions.

 

  • Other stress conditions :
    Photo-stability UV and Visible
    Cyclic temperature conditions from -15°C to +40°C.

 

  • Climatic storage conditions :

5°C ± 3° C
25°C  ± 2°C / 40% RH  ± 5% RH
25°C  ± 2°C / 60% RH  ± 5% RH
30°C  ± 2°C / 40% RH  ± 5% RH
30°C  ± 2°C / 60% RH  ± 5% RH
30°C  ± 2°C / 65% RH  ± 5% RH
30°C  ± 2°C / 70% RH  ± 5% RH
30°C  ± 2°C / 75% RH  ± 5% RH
40°C  ± 2°C / 25% RH  ± 5% RH
40°C  ± 2°C / 75% RH  ± 5% RH