AMPAC Analytical offers ICH stability storage and testing to support all of your cGMP stability requirements.
We offer a wide range of ICH storage conditions for stability storage of long-term, intermediate and accelerated testing. Our facilities are also capable of performing stability storage for drug product packaged in semi-permeable containers as well as DEA schedule II –V controlled substances.
Available Stability Services:
- Protocol writing
- Report writing
- Long-Term Stability Storage and Testing
- Intermediate Stability Storage and Testing
- Accelerated Stability Storage and Testing
- Forced Degradation Studies
- Temperature Excursion/Cycling Studies
Available ICH Storage Conditions:
- 40°C/NMT 25%RH
- Photostability per ICH Q1B
- Custom Storage Conditions upon request
All conditions are maintained at set-points and tolerances outlined in the ICH guidelines. All chambers have controlled access and are fully mapped and qualified. Temperature and humidity are continuously monitored by a validated computerized chart recorder. Alarms are set for out of tolerance events and notifications are generated and sent to responsible personnel. All chambers and electronic chart recorder have a redundant backup power supply.