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Tag Articles : Photo Degradation

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  ICH Testing of Pharmaceuticals – Part 1 - Exposure Conditions

  December 13, 2021 | Dr. Oliver D Rahaeuser

  Applications

  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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  SUNTEST CPS+ and its Role in Drug and Doping Studies

  November 15, 2021 | Dr. Oliver D Rahaeuser

  Applications

  Hair analysis is a valuable tool in clinical and forensic toxicology to reveal drug and/or doping abuse and single dose consumption. Studies often stand in the context of crimes, doping controls, or workplace drug testing with a large window from weeks to months for drug detection.

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