Stability Studies

  • Long-term stability studies according to ICH guidelines
  • On-going and follow-up stability studies
  • Comparability studies
  • Stress tests, forced degradation
  • Photostability testing according to ICH guidelines
  • In-use tests, freeze-thaw cycles
  • Excipient/API compatibility
  • Interaction studies with primary packaging
  • Stability protocols, reports and interim reports
  • Stability indicated method development
  • Identification of unknown/new impurities

 

Our Facilities:

Walk-in Chambers
5 °C
25°C/60% r.H.

50 m2 total storage capacity/walk-in chamber


Climate Cabinets
5°C
25°C/60% r.H.
30°C/65% r.H. and 30°C/75% r.H.
40°C/75% r.H.
-20°C
-80°C



Other storage conditions available on request.

 

Stability Studies

Stability Studies

HPLC chromatogram - stability testing

Walk-in_chambers

Walk-in_chambers

Walk-in chambers