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 stable storage of long-term, intermediate, and accelerated testing. Our facilities are also capable of performing stability storage for drug products 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 recorders have a redundant backup power supply.