Pharmaceutical Photostability Testing: Small and Large Molecules According to ICH Guidelines

This presentation explains essential photostability testing requirements for small (traditional pharmaceutical) molecules and large (biotechnology products) molecules according to the ICH Q1B and Q5C guidelines. It also explains the basics of what needs to be tested (such as active pharmaceutical ingredient, final finished product, product as packaged, etc.), when it needs to be tested, the light exposure devices used per the ICH requirements, sample presentation and general tips.

Best Practices • Calibration • Chambers • Sample Control • Study Design