Moravek offers stability studies as an optional service in addition to production, which includes secure storage and analysis in a dedicated Quality Control laboratory. Stability studies are routinely performed on radiolabeled products since the addition of a radiolabel can affect the stability in unpredictable ways, even if the non-labeled version of the compound is very stable. Stability studies are available for all Moravek custom products.
Our GMP stability chambers
Our stability studies include:
- Several temperature options (controlled room temperature [+25 °C/60% RH], +4 °C, -20 °C, and -80 °C)
- Analysis according to the approved stability study protocol
- Aliquot preparation for all requested time points and storage conditions
- All results and a final stability study report
- CoA with updated retest date (if applicable)
Results of stability testing are provided at each time point and a final stability report is provided at the end of the stability study to summarize the results over all time points. An updated retest date may be assigned if the material meets stability criteria.