The current ICH (International Conference for Harmonization) guidelines specify that drug and drug products must be phototested to ensure that exposure to light does not cause photochemical degradation of the product or packaging.
Radiant and luminous exposure limits are given for phototesting in both the UV-A and Visible spectral regions. The product under test must receive a measured dose of both UV-A (200 watt-hours per square meter) and Visible (1.2 million lux-hours) optical radiation exposure. This requires both radiometric and photometric measurements in terms of illuminance in lux and UV-A (315 to 400 nm) irradiance in W/m² multiplied by exposure time in hours.
Currently the ICH lists only a few light sources qualified for use in phototesting. The sources specified could create measurement problems for broadband radiometers and photometers without calibration correction or the correct spectral design.
Additional information from our Products section:
Multi-Channel Illuminance/Irradiance Light Detector: XD-9502
Possible Optometer: X11, X98
Additional information from our Tutorials section: VI.6. Photostability
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