Stability testing support

cGMP stability services

  • cGMP registration stability studies

  • In-house studies and storage management

  • Forced degradation testing

 

Storage of stability testing samples

We offer a wide range of storage conditions and we understand that reliability is a key performance factor in storage of stability testing samples. To ensure temperature and relative humidity during the total stability study’s time frame, our storage rooms are continuously conditioned and controlled. An alarm system will be activated if any condition falls out of specification. At our laboratories, samples can be stored according to ICH conditions, custom stability studies and storage testing is also possible.

 

Setup of stability studies

  • The custom setup of stability studies is possible:

  • In general, we edit a study protocol before start up. Also, testing for APIs, clinical trial materials, formulated products

  • Tailored reporting: time point and final reports

  • All ICH conditions storage

  • Custom or specialized conditions

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