Long-term Stability Testing
目的We assess that the physicochemical properties of the drug substance or drug product are properly maintained in the intended storage method.
The stability of the API or drug product is evaluated using storage conditions that promote chemical and physical changes, such as 40°C storage.
Forced Degradated Studies
The stability of the drug substance or drug product is evaluated under more severe conditions than in accelerated studies.
In-use Stability Testing
We evaluate the stability of a pharmaceutical product after it is dissolved or diluted by the desired preparation method, including the determination of the amount of aggregate in the drug product after the addition into an IV bag.
Interfacial Stability Testing
Stresses such as shaking, dropping, and agitation can cause denaturation and aggregate formation of pharmaceuticals through mechanisms different from long-term storage. We use a variety of methods to evaluate interfacial stability.