Aureole Pharma Tech Photostability Chambers are meticulously designed in strict accordance with the ICH Q1B guidelines, recognizing the pivotal role that light testing plays in stress testing protocols. These chambers offer precise control and monitoring of temperature, with the option for humidity regulation, and most importantly, they closely track light intensity exposure on both the drug and drug substances under evaluation.
For confrmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours / square meter to allow direct comparison to be made between drug substance & drug product.
Aureole PharmaTech’s Photostability Chambers are designed specically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is Approved performed simultaneously according to ICH Q1B option 2.