Real-time and accelerated stability testing

Stability testing of a formulated product is always a part of a formulation program for an active pharmaceutical ingredient nominated for clinical development.  Long-term stability, meaning stability on storage, requirements vary widely from drug to drug, and can be months to years.

Monitoring real-time stability under conditions that simulate real-world storage conditions of a product in its storage container is ideal.  Commonly, accelerated stability testing, wherein a drug formulation is placed under controlled elevated temperature and humidity conditions, is conducted concurrently to detect possible early warning signs of potential stability problems.  On the basis of real-time and accelerated stability testing modifications may be made on the long-term storage form and selection of container/closure systems.

WLI performs stability testing following the guidelines established by the International Conference on Harmonization (ICH).  We operate dedicated ICH-compliant stability chambers for room temperature, refrigerated, and accelerated stability conditions, and an ICH-compliant chamber for light sensitivity testing.  Customized testing conditions are available.