Aptuit | Integrated CMC | Stability

Stability testing and sample storage

Extensive. Comprehensive. Fully validated.

Our stability testing and sample storage options are extensive, comprehensive programs providing fully validated and continuously monitored storage environments for all ICH and WHO test conditions. 

Aptuit | Stability testing

Our analytical capabilities also encompass the ability to evaluate the physical, chemical, and microbiological properties of solids, liquids, semisolids, and parenteral formulations.

Our expert teams and extensive facilities can also support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing, statistical support for stability testing and statistical evaluation of both long-term and accelerated stability data.

We take care to ensure our analytical equipment is qualified and calibrated with full documentation covering the IQ/OQ/PQs, as well as routine and non-routine maintenance. While our access to validated data handling networks allows us to compile and deliver data to our clients quickly and efficiently.