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
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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