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 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's on-site storage stability facilities are located in Whitehouse, NJ (USA), PROBE (Australia) and Manchester, (UK). These laboratories meet the relevant national and international regulations from FDA, MHRA, EMEA, TGA, Health Canada etc.
'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
Stability testing provides essential data on how the quality of a pharmaceutical varies over time under the influence of different environmental factors such as temperature, humidity and light. This enables recommended storage conditions, re-testing intervals and shelf-lives to be established. Comprehensive testing capabilities also include dissolution, Karl Fischer, hardness, disintegration, friability and characterization of impurities and degradants.
Related Pharmaceutical Services
Request more information to see how Intertek can help your organization with Stability Testing and Storage.