Stability studies in the pharmaceutical industry are performed to determine if the quality of a drug substance or product is altered over time by various environmental factors (light, temperature, humidity).
By stability testing, a product shelf-life is determined that guarantees product safety and efficacy.
ICH Stability Testing
In our laboratory we are following ICH guidelines for stability testing. The products are stored in climate chambers at defined storage conditions for long-term (real-time) and accelerated stability studies.
The testing frequency and storage conditions is specifically determined for each product in order to provide sufficient data to establish the product stability profile.
Data from the accelerated stability testing should be supported by the real-time data that cover the predicted shelf-life of the product.
If you need reliable partner for stability testing Contact us.