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Q-SUN ICH Guidelines - 2 Pages

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Q-SUN ICH Guidelines

Catalog excerpts

Photostability Testing for Cosmetics & Pharmaceuticals (ICH Guidelines & Forced Degradation) The Q-SUN® xenon test chamber from Q-Lab offers state of the art, full-spectrum photostability test exposures for pharmaceutical and cosmetics applications. Q-SUN testers are available in two sizes with options that meet ICH Guidelines for Photostability Testing of New Drug Substances and Products, including simulation of direct sunlight or sunlight through window glass. Accurate control of light intensity and temperature ensures repeatable and reproducible results. These features enable the Q-SUN chamber to perform photostability tests according to in-vitro test procedures for sunscreens. Key Features: Simplicity & Accuracy • • • • • Simple operation and lamp replacement so you can concentrate on what’s most important: your tests! Full spectrum xenon arc lamp and optical filter system creates D65 and ID65 sunlight simulations that enable you to test your products against outdoor or indoor daylight. SOLAR EYE® Irradiance Control monitors and controls the light intensity to ensure your tests are repeatable and reproducible. Precise control of chamber air or black panel temperature gives you flexibility to determine the effects of different temperature environments on photodegradation. Optional chiller unit enables tests to be run at room temperature or as low as 15°C so you can determine the synergistic effects of light and heat on your materials and products. Two Sizes All the Critical Features This chart shows the Q-SUN chamber's Daylight-Q filter compared to D65 outdoor sunlight. This chart shows the Q-SUN chamber's Window-Q filter compared to ID65 indoor daylight. The Q-SUN tester comes in two sizes with all the critical features for pharmaceutical and cosmetics applications. The Xe-1 is available in a convenient tabletop size and offers an optional chiller. For labs that need high throughput, the Xe-3 is a freestanding unit with triple the capacity. The Xe-3 also provides precise control of relative humidity.

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ICH Guidelines Photostability testing of drug substances and products can be done several ways according to the ICH Guidelines. Regardless of whether Option 1 or Option 2 is chosen or which light source within each option is used, the exposure requirements are defined as minimum values within the visible and ultraviolet ranges: • • Visible Light: 1.2 million lux-hours. Ultraviolet Light: 200 w-hr/m2 of integrated UV energy (spectral range of 300-400 nm) Bottles and other oddly-shaped samUnder the ICH Guidelines, it is perfectly acceptable to expose speciples can be easily tested in a Q-SUN...

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