Pharma

• Pharma GMP
• Research center GLP
• Reach

• Introduction
• Quality control
• Research and Development
• Stability studies
• Services for pharmaceutical companies
• Molecular biology studies
• Biopharmaceutical services
• Medical devices
• Authorizations

STABILITY STUDIES

 

In Chelab GMP facility walk-in climatic chambers are in service for stability tests. They are qualified and continuosly monitored for temperature and humidity.

Three 22 m3 climatic chambers are dedicated to the storage of samples according to ICH standards:

25°C ± 2°C - 60%UR ± 5%UR
30°C ± 2°C - 65%UR ± 5%UR
40°C ± 2°C - 75%UR ± 5%UR.

Other climatic chambers and conditioning systems (photostability cabinets, thermostatic cabinets, etc..) are dedicated to stability studies according to ICH, CIPAC and others.

The following studies are performed:

• Accelerated stability and long-term for registration purposes
• follow up stability
• in-use stability
• on-going stability
• Photostability
• Forced degradation (stress test)
• Identification of unknown degradation products

 

FOR TECHNICAL OR COMMERCIAL INFORMATION-