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:

  • 5°C
  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH
  • -20°C
  • 25°C/40%RH
  • 40°C/NMT 25%RH
  • 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.

See our services, submit a sample or request a quote now!