Stability testing & storage

We can support you with stability testing programs for drug substances and drug products that meet the requirements of the ICH Guidelines Q1A-F and Q5C.

We compile stability protocols containing the stability specifications and the chosen methods, justified as stability indicating. Each stability study is specifically designed to your project needs with analyses of attributes that are susceptible to change during storage. Prior to stability testing, it might be necessary to establish the stability indicating capacity of some methods. We can assist your project with a range of stability-indicating methods to perform complete studies under long-term, intermediate and accelerated conditions.

Our stability testing services:

  • Initial testing of stability indicating methods
  • Long-term, intermediate and accelerated stability studies
  • Forced degradation studies
  • Freeze-thaw stability studies
  • Photostability testing
  • Shipment simulation studies

Process intermediates & storage

Intermediate substances, created during the manufacturing of drug substances, may not be immediately processed. In these cases, stability testing may be required. For example, the stability of inclusion bodies has to be demonstrated from isolation to downstream processing.

We can offer you a wide range of storage conditions according to ICH Guideline Q1A or any custom requirement:

  • 25 °C at 60 % RH
  • 30 °C at 65 % RH
  • 40 °C at 75 % RH
  • 2 – 8 °C
  • -20 °C
  • -80 °C

The cooling devices and climatic exposure cabinets are equipped with data loggers permanently recording temperature and humidity. Additionally, all devices are connected to a 24/7 alarm system.

Regardless of the analytical method, an adequately characterised reference material must be available for the vast majority of analytical assays. For some tests key reagents like antibodies are required. These need to be maintained in a qualified state. We offer stability and retest programs to ensure the ongoing suitability and reliability of reference materials and critical reagents.

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