Eurofins BioPharma Product Testing Czech Republic s.r.o. performs photostability studies according to ICH Q1B using the photostability chamber set at 25°C / 60 % RH with sensors calculating the total illumination and automated turning off of the UV and VIS lamps after reaching the required dose.

For the forced degradation studies of small amounts of samples we use separate instrument with illumination time lower than 24 hours.

FREEZE / THAW STUDIES

We can also perform cyclic studies. We can combine them with our ASAPprime® studies.

ASAPprime® studies

ASAPprime® = how to determine stability of drug product or drug substance – faster and cheaper

ASAPprime® offers:

• FASTER SHELF-LIFE DETERMINATION » 2-4 weeks vs. ICH-based standard of 2-6 months
• OPTIMAL PACKAGING SELECTION » Eliminates screening » Allows for zone packaging selection
• SUPPORT OF REGULATORY FILINGS » Provides better insights into packaging and formulation/process choices » Supports QbD filings » Replaces or supplements ICH-based studies for FDA and other regulatory agencies world-wide
• STABILITY » Accurately assess stability and shelf life variation between product lots