Stability Studies
We carry out Stability Studies according to ICH Guidelines:
- Procedures for the registration of Stability Studies.
- Protocols and Reports.
- Fluorescent / UV radiation for photo-stability studies.
Study period | Conditions |
---|---|
Long term (IV) | 25ºC ± 2ºC / 60% HR ± 5% HR |
Long term (IVB) | 30ºC 75% HR |
Intermediate | 30ºC ± 2ºC / 65% HR ± 5% HR |
Accelerated | 40ºC ± 2ºC / 75% HR ± 5% HR |


Climatic Chambers