Stability operations is a full service department offering stability protocol design and preparation, coordination and execution of stability testing, sample storage, preparation of data reports and stability tables, and data trending and extrapolation for support of product shelf-life predictions. Stability programs can be created to meet regulatory requirements or to help gain other information necessary for successful product development.
Statistical stability predictions are performed using SlimStat™ Software.

Temperature/Humidity Controls:

ICH Conditions:

25° C/40%RH 25° C/60%RH
30° C/35%RH 30° C/60%RH
40° C/20%RH 40° C/75%RH

Photostability
Light Exposure / Temp. Control:

ICH Option 2 with Temperature Control and Monitoring at 25 °
Fluorescence 200-1000 foot candle
Room Light/CRT