ICH climate conditions
Eurofins Sinensis offers cGMP stability testing and storage programs (Storage Stability) for a wide range of pharmaceuticals and related healthcare products to meet ICH guidelines. In addition we provide specialized non-standard climate conditions.
‘Walk-in’ chambers are available for most standard ICH conditions and ‘reach-in’ chambers for specialized conditions. All chambers are continuously monitored by automated monitoring systems with full back-up. ICH stability services include long-term stability, accelerated stability, photostability, comparative stability, freeze-throw and forced degradation storage.
Storage Stability Conditions
- ≤ - 60 °C
- - 20 ± 3 °C (Frozen)
- 5 ± 3 °C (Refrigerated, Accelerated frozen)
- 15 ± 3 °C
- 25 ± 2 °C / 40 ± 5 % RH
- 25 ± 2 °C / 60 ± 5 % RH (ICH zone II, Accelerated Refrigerated)
- 30 ± 2 °C / 65 ± 5 % RH (ICH zone IVa, Intermediate)
- 30 ± 2 °C / 70 ± 5 % RH
- 30 ± 2 °C / 75 ± 5 % RH (ICH zone IVb)
- 40 ± 2 °C / 75 ± 5 % RH (Accelerated Ambient)
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 photostability. 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.
If you require advice or more information of our storage stability, please contact us to discuss your specific needs. If you are a step ahead and wish to request a quotation, fill in this form and explain your needs if possible. We will contact you as soon as possible.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom services. Whenever necessary, additional services like pure culturing and/or testing of more, other genes can be provided. Please contact us if you want to discuss your needs.