December 13, 2021
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Dr. Oliver D Rahaeuser
The FDA (American Food & Drug Administration) requires that all new drugs be tested for shelf life by exposing drugs to simulated sunlight. The international ICH guidelines define appropriate light sources and provides test guidelines. The guidelines Q1B state that drugs must be exposed to a minimum of 1.2 million lux-hours of visible light and a minimum of 200 W·h/m2 UVA light. These tests are also referred to as Confirmatory Studies.
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