At Aptuit, the stability testing and sample storage options represent extensive, comprehensive programs that provide fully validated and continuously monitored storage environments for all ICH, WHO, and ASEAN test conditions.  In addition, we provide analytical capabilities to evaluate the physical, chemical, and microbiological properties of solids, liquids, semisolids, and parenteral formulations.

 

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

 

We provide the following services: 

• Protocol Design per ICH for global registration
• Evaluation and summary reporting of Stability Data
• IND/NDA/MAA filable summary data tables
• Statistical evaluation of data
• Sample storage in fully mapped, qualified, and continuously monitored walk-in and reach-in chambers

 Conditions for walk-in and reach-in chambers: