Stability Studies

SynCo offers stability testing according to ICH guidelines. Dedicated stability chambers for the following temperatures are available at SynCo: -70°C, -20°C, 2-8°C, 25°C/60% RH. Stability testing at other temperatures is possible and can be discussed in more detail with our QC department. 

The stability studies can be provided for a range of different product stages, including drug intermediates, bulk drug substance and drug product material. 

SynCo’s stability testing services include:

  • Stability indicating assay development
  • Protocol generation
  • ICH and non ICH conditions
  • Real time, accelerated and degradation studies
  • Interim reports for every testing period
  • Final stability report 

If you are interested in find out more about the stability services SynCo provides, please contact us.