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

 Climatic storageClimatic 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

         

All of our analytical equipment is qualified with full documentation covering the IQ/OQ and PQ and, the storage option is fully compliant with ICH and WHO requirements.

 

 

 

 

 

 

GALENIX INNOVATIONS - Allee des Palanques - 33127 ST JEAN D'ILLAC - FRANCE

Tel: +33 (0)826 39 69 18 - Fax: +33 (0)5 56 68 83 01