Pharma Workshop

Date Event Location Country Language Type
Nov 05, 2018 Pharma Workshop Dublin Ireland EN Workshop Register

Photostability testing of drug products
Seminar and workshop according to ICH guidelines

This seminar addresses photostability testing of pharmaceuticals focusing on the harmonised ICH* guidelines Q1B and Q5C on stability testing of new active substances and medicinal products. Photostability testing should be an integral part of stress testing. The intrinsic photostability characteristics of the new active substances and medicinal products must be evaluated, to demonstrate that light exposure does not result in unacceptable change.

At this seminar and workshop the basic principles of the photochemical degradation of medicinal products is described. Procedure in accordance with ICH guidelines is presented and discussed. This includes testing instrumentation with option 1 and option 2 light sources, calculation of testing times and basic principles of sample handling.

Handling of the testing material is demonstrated using testing instrumentation with Option 1 light source class 1, SUNTEST CPS+.