Stability studies

At Sortis, we are ideally placed to provide stability testing for all stages of drug development. Our stability storage infrastructure includes sophisticated walk-in chambers, climate cabinets and an emergency backup for power breakdown. All our processes take place on one connected site, where there is a high degree of QC expertise, scientific dialogue and maximal sample preservation.

Testing we regularly perform includes:

Long-term stability studies according to ICH guidelines
Ongoing and follow-up stability studies
Comparability studies
Stress tests, forced degradation
Photo stability testing according to ICH guidelines
In-use tests, freeze-thaw cycles
Excipient/API compatibility
Interaction studies with primary packaging
Stability protocols, reports and interim reports
Stability indicated method development
Identification of unknown/new impurities

Services offered

Analytical

Stability studies

Testing we regularly perform includes:

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