Thanks to our statitsical and expert rule-based QSAR models of genotoxicity combined with in vitro assessment, we provide you with a tailor-made investigation of your APIs regarding ICH M7 regulatory requirements.
As requested by the ICH M7 Guideline, any identified impuritie is processed through two complentory QSAR methods : Statistical and Expert rule-based.
In the case of inconclusive in silico results about a potential genotoxicity, the impurities are assessed with in vitro AMES assays by our partner GenEvolutioN.
Data from the proposed investigations are reviewed by an expert toxicologist to consolidate compliance with regard to the ICH M7 guideline and regulation.
a minimum of 3 compounds to be processed
|Price per compound (excluding VAT)|
|IN SILICO INVESTIGATIONStatistical and Expert rule-based QSAR models||2 000€|
|IN VITRO INVESTIGATIONAmes test with 5 strains ; regular or GLP compliant||quotation upon request|
We provide you with a tailor-made support to add value of your APIs
Once the structure of your impurity has been established, we process the compound by use of its 2D structure to calculate chemical descriptors.
The chemical descriptors of the impurity are then processed through our two statistical and expert rule-based QSAR models in order to classify the impurity as non-mutagenic (class 5) or mutagenic (class 1 or 2).
In the case of inconclusive prediction from the statistical AND/OR expert rule-based methods (class 3), the impurity is tested in an in vitro Ames type assay to confirm its potential genotoxic/mutagenic character.
You get an in-depth report about the impurity reviewed by an expert toxicologist that helps you document the regulatory file of your API.