For Confirmatory 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.
MACK PHARMATECH’s Photo Stability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is performed simultaneously according to ICH Q1B option 2.
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