A combined in silico + in vitro offer to characterize genotoxic impurities (GTIs)

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.

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An Integrated Offer

🔹 European regulation “ICH M7 guideline”

That regulation frames the identification of residues deriving from the synthesis of APIs and suggests the use of in silico and in vitro based investigations as level 1 and level 2, respectively.

🔹 In silico investigation – level 1 according to OECD

Our QSAR* based statistical and expert rule-based models allows to generate alerts about impurities regarding their potential mutagenic toxicity according to their molecular features.
(*Quantitative Structure-Activity Relationship)

🔹 In vitro investigation – level 2 according to OECD

Thanks to our partnership with the company GenEvolutioN, we offer to complete our genotoxicity investigation with experimental assessments like Ames assays with five strains.

Getting benefits right away

✔️ STRUCTURAL ALERTS FROM TWO QSAR MODELS

As requested by the ICH M7 Guideline, any identified impuritie is processed through two complentory QSAR methods : Statistical and Expert rule-based.

✔️ AMES - EXPERIMENTAL ASSESSMENT

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.

✔️ BE COMPLIANT WITH ICH M7 REGULATION

Data from the proposed investigations are reviewed by an expert toxicologist to consolidate compliance with regard to the ICH M7 guideline and regulation.

A straightforward rate

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
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Decision making support

We provide you with a tailor-made support to add value of your APIs

How does it work?

You send us the chemical structure of your impurity.

Once the structure of your impurity has been established, we process the compound by use of its 2D structure to calculate chemical descriptors.

The potential genotoxicity of your impurity is evaluated with our QSAR based models.

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).

When needed, we assess the in silico data with experimental assays.

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 are compliant with the ICH M7 regulatory guidelines.

You get an in-depth report about the impurity reviewed by an expert toxicologist that helps you document the regulatory file of your API.