Forced Degradation Studies

Stress test for substances & methods
insights to degradation pathways and method performance

Forced degradation studies also known as Stress Testing of drug substances or drug products according to ICH Q1A and ICH Q1B predict likely degradation products or degradation pathways. They can also demonstrate the stability indicating power of analytical methods used.

Suisse TP performs Forced Degradation Studies according to ICH Q1A(R2) Stability  testing of
new drug substances and products
that includes the investigation of the following effects:

  • Temperature
  • Humidity
  • Oxidation
  • Photostability acc. to ICH Q1B
  • Susceptibility to hydrolysis caused by acids and bases

The whole offer includes:

  • Design of the Forced Degradation Study
  • Creation of the Forced Degradation Study plan
  • Performance of stress tests and analytical characterization of stressed samples
  • Evaluation of analytical measurement data
  • Creation of the Forced Degradation Study report

Need an external CRO?

Contact me!

Rahel Wahrenberger

Chemikerin HTL / Ausbilderin FA

Tel: +41 52 551 11 60