Stress test for substances &amp; methods –
insights to degradation pathways and method performance 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.
We perform FDS according to ICH Q1A(R2) that includes the investigation of the following effects:
<ul>
 <li>Temperature</li>
 <li>Humidity</li>
 <li>Oxidation</li>
 <li>Photostability acc. to ICH Q1B</li>
 <li>Susceptibility to hydrolysis caused by acids and bases</li>
</ul>
The whole offer includes:
<ul>
 <li>Design of the Forced Degradation Study</li>
 <li>Creation of the Forced Degradation Study plan</li>
 <li>Performance of stress tests and analytical characterization of stressed samples</li>
 <li>Evaluation of analytical measurement data</li>
 <li>Creation of the Forced Degradation Study report 
&nbsp;</li>
</ul>
OUR CRO Competences:
<ul>
 <li><a href="https://cro.suisse-tp.ch/process_development_and_optimization/" target="_blank">PROCESS DEVELOPMENT &amp; OPTIMIZATION</a></li>
 <li><a href="https://cro.suisse-tp.ch/custom-synthesis/" target="_blank">CUSTOM SYNTHESIS</a></li>
 <li><a href="https://cro.suisse-tp.ch/method-development-validation-transfer/" target="_blank">ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND TRANSFER</a></li>
 <li><a href="https://cro.suisse-tp.ch/analytical-services/" target="_blank">ANALYTICAL SERVICES</a></li>
 <li><a href="https://cro.suisse-tp.ch/forced-degradation-studies/" target="_blank">FORCED DEGRADATION STUDIES</a></li>
 <li><a href="https://shelf-life.suisse-tp.ch/" target="_blank">PHARMA PACKAGING SERVICES</a></li>
 <li><a href="https://cro.suisse-tp.ch/nbcd-characterization/" target="_blank">NBCD CHARACTERIZATION</a></li>
</ul>