Stability testing is required to provide evidence on variations in the quality of a drug substance or drug product over time as affected by a range of environmental factors (temperature, humidity, light etc).
Stability testing is also necessary to define the shelf life and storage recommendations for drugs.
Test conditions are chosen based on the climate conditions in different regions. Averica’s stability programs support studies in all ICH climatic zones, and allow the development of custom study protocols.
Full Range of Environmental Conditions for All ICH Zones
Types of Studies
In addition to "standard" drug substance and drug product testing and storage, we often design specific studies supporting drug use and storage under real life conditions
In-use Stability Studies
Photostability studies (ICH Q1B, Option II)
Packaging and Container Closure System Studies
Narcotics Stability Testing
Are You Interested in Stability Testing?
The Averica Advantage
We offer a full range of stability testing and storage services to meet the performance needs of our clients. A dedicated staff and specifically designed software provides total management of stability programs including timely reports, interpretations and recommendations.
Going from Stress Degradation to a Stability-Indicating Method: Analytics and API Development
How Relevant is Stress Degradation to Real Life Pharmaceutical Stability?
What Is The Degradation Knowledge Space, And How Is It Used To Understand Stability?