Stability Testing and Storage
Comprehensive ICH stability services for pharmaceuticals and biopharmaceuticals with a full range of conditions for ICH storage stability and accelerated stability testing.
Intertek offers cGMP-compliant stability testing and storage programs for a wide range of pharmaceuticals (including biologics / biosimilars - see below) and related healthcare products to meet ICH guidelines, in addition to providing specialized non-standard conditions. Comprehensive analytical method development and validation capabilities support testing of API's, clinical trial materials (CTM's), finished products, medical devices and compatibility of formulation components.
Intertek on-site storage stability facilities are located at QTI (Whitehouse, NJ), Bioclin (Ireland), PROBE (Australia) and ASG (UK). 'Walk-in' chambers are available for all standard ICH conditions and 'reach-in' chambers for specialized conditions. All chambers are continuously monitored by automated monitoring systems with full back-up power and water supplies. ICH stability services include long-term stability, accelerated stability, photostability, comparative stability and forced degradation studies (including characterization of degradants).
Storage Stability Conditions:
- 25ºC / 60% RH
- 30ºC / 60% RH, 30ºC / 65% RH and 30ºC / 70% RH
- 40ºC / 75% RH
- 50ºC / 75% RH
- 2-8ºC, -20ºC, -40ºC and -80ºC storage capacity
- Photostability (ICH Options 1 & 2)
- Specialized conditions
Related Pharmaceutical Services
Request more information to see how Intertek can help your organization with Stability Testing and Storage.



