Long term studies according to the valid ICH-Guidelines
We carry out reliable stability testing in accordance with the valid ICH guidelines as long-term studies, accompanying process changes and in all developments. For almost all finished products, the ongoing-stability studies are carried out in our company.
Our highly qualified laboratory teams have modern and efficient equipment at their disposal. This includes 10 HPLCs including a device with the latest UPLC technology, two GCs with direct injection and headspace sample application, fully automated dissolution testers, NIR spectrometers and UV/VIS spectrometers.
Generously dimensioned climate chambers for the different ICH climate zones are available for the performance. The systems are connected to the central building management system and are permanently monitored.
Your advantages with Wiewelhove stability analyses
Previous validation at our premises
Inspection according to valid ICH-Guidelines