Stability Analyses

Reliable stability testing in compliance with the applicable ICH guidelines is performed for all development projects in the form of realtime studies in association with any process modifications. Ongoing stability studies are performed in-house for almost all finished products.

For this purpose our highly qualified laboratory team disposes of modern and efficient equipment. This includes 10 HPLCs including a device with the most modern UPLC technology, two GCs with direct injection and headspace sample transfer, fully automated dissolution testers, NIR spectrometers and UV/VIS spectrometers.

Spacious climatic chambers for different ICH climatic zones are available for performance. The systems are connected with the central facility management system and are premanently monitored.