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Genotoxic impurities – new guideline ICH M7

The Ames MPF and Ames II kits are two microsystems cited in the ICH M7 guideline for genotoxic impurities and are preferred  by the pharmaceutical industry due to their low consumption of compound and high sensitivity. In addition, the kit system offers additional advantages such as significant less hands on time and possibilities for automation, less contaminated waste and thus less environmental pollution. Up to 12 x less rat liver S9 follows the 3Rs philosophy reducing test animals.

For more information download the Presentation "Use of Ames MicroPlate Fluctuation Assay in ICH M7 Guideline for testing genotoxic impurities"