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.
- 25°C/60% RH (ICH zone I and II conditions)
- 25°C/40% RH (Permeability studies)
- 25°C/75% RH (Permeability studies)
- 30°C/65% RH (ICH zone IV a conditions)
- 30°C/75% RH (ICH zone IV b conditions)
- 40°C/75% RH (Accelerated stability)
- 2°C to 8°C (Refrigerated conditions)
- -20°C ± 5°C (Freezing conditions)
Types of Studies:
In addition to “standard” drug substance and drug product stability testing and storage, we often design specific studies supporting drug use and storage under real life conditions.
Transport studies may be required to justify temperature or humidity excursions during transportation or warehouse storage. Cycle test and Freeze/Thaw studies are commonly used to support these requirements. Our work includes protocol design and results interpretation.
Similar to transport studies, variation in storage conditions under use may require investigation of stability under conditions of changing temperature or humidity. We offer protocol design, custom study, and results analysis on Cycle testing and Freeze/Thaw studies.
Photostability testing (light testing) is a requirement under ICH Q1B, to demonstrate that exposure to light does not change the drug. Our testing programs support drug substance, drug product (packaged and unpackaged). For maximum information content from photostability work we recommend and use the ICH option 2 procedures, exposing materials to fluorescent and near-UV light sources.
Stability studies compare different packaging materials and container closure systems. Test applications support post market changes such as manufacturing site, container/closure, and product formulation changes. In addition, stability studies (accelerated or long term) may be used in evaluating leachable or extractable contaminants in drugs.
Averica has the registrations and capabilities to support stability studies for all controlled substance schedules under US DEA and Health Canada regulations.
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.
- GMP facility with 15,000 cubic feet of walk-in/reach-in chambers/incubators
- Flexible incubators to perform stability studies under stress conditions (customized)
- All chambers are fully mapped, qualified, controlled and 24/7 monitored with alarm system (21 CFR part 11 compliant)
- Customized data recording and reporting, including OOT trending, available upon request
- Storage available for short and long term durations, alone or with analyses
- Trend analysis by Arrhenius calculation by a validated software in order to optimize the development of product formulations
- We also support special storage conditions customized to a client’s specific needs.