GMP Stability Studies

A stability study aims to provide essential data on how the quality of a material changes over time. Moravek’s reliable stability studies can evaluate the stability of your GMP 14C-labeled active pharmaceutical ingredient (API) in the desired final form and help inform decisions such as usage timing.

Our GMP-compliant stability studies include secure storage and analysis in a dedicated Quality Control laboratory. Stability studies are often performed on the material generated during the technical batch, so that the stability information can be obtained before the GMP batch is completed.

Our trusted stability studies include:

  • Stability chambers with 24/7 temperature monitoring
  • Temperature options include controlled room temperature (+25 °C/60% RH), +4 °C, -20 °C, and -80 °C
  • Analysis according to the approved stability protocol
  • Aliquot preparation for all requested time points and conditions
  • All results and a final stability study report
  • Certificate of Analysis with updated retest date (if applicable)

Our GMP stability chambers are continuously monitored by a 21 CFR Part 11 compliant Rees Scientific Environmental Monitoring System. Temperature and pressure are recorded in all chambers and the relative humidity of the +25 °C/60% RH chamber is also recorded. Periodic requalification of the stability chambers is carried out with Rees Scientific temperature mapping.

The stability chambers operate with automatic backup power from a 500-kW generator. This cloud-enabled, facility-wide backup power system from Cummins eliminates the worry of temperature excursions of the stability study samples caused by power outages.

The results of the stability study are provided at each of the requested time points. At the end of the stability study, a final report is provided to summarize the results over all time points. An updated retest date may be assigned if the material meets stability criteria.

Contact our knowledgeable customer service team with any questions regarding our GMP-compliant stability studies. Non-GMP stability study services are also available; please inquire.