Genotoxic Impurities – the ICH M7 Guideline

The ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) has published the finalized M7 guideline dealing with the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The guideline also offers guidance on analysis of structure activity relationships (SAR) for genotoxicity.

The M7 guideline reached step 4. That means that the M7 guideline must now be implemented into the national guidelines of the ICH regions (Europe, America, Japan) (step 5). But the Ames test, mentioned in the M7 guideline, must be conducted according to M7 with immediate effect.

The Ames MPF kit, provided by hjs consulting, can be used for the determination of impurities. The requirement of test substance is 4 times less compared to the traditional Ames test and is therefore the predestinated test system if compound quantity is limited. This miniaturized assay, explicitly mentioned in Note 2 of the M7 guideline, has a proven high concordance.

If you have any questions concerning the Ames MPF Kit and its use for the determination of impurities, please do not hesitate to contact use.