Forced Degradation Studies

IAS provides forced degradation/stress studies involving drug substance exposure to heat, humidity, and light for solid-state studies. In contrast, stress studies are performed using acid-based hydrolysis and oxidation at various temperatures in solution form. The laboratory is equipped with a photostability chamber that provides photostability testing of drug substances and drug products, as per ICH guidelines, by exposing the sample minimum of 1.2 million lux hours and 200 watt-hours per square meter light with controlled and variable temperature and humidity. The lab is equipped with highly sophisticated instruments such as LCMS and GCMS. It can help in the identification of degradation products in stress studies.