# ICH M7 impurity assessment — Mutagenic impurities

> Clear mutagenic-impurity calls with the trail to back them.

ICH M7 asks you to assess and control DNA-reactive impurities, and the classification hinges on structural alerts and a defensible (Q)SAR read. ToxIndex runs that assessment as a reproducible workflow so every impurity call carries its evidence.

## The M7 workflow, made reproducible

ICH M7 leans on two complementary (Q)SAR methodologies and expert review to place each impurity into a control class. Doing that by hand across a synthetic route — starting materials, intermediates, reagents, degradants — is slow and hard to reproduce when an auditor asks how you got there.

Flow runs the assessment as an ontology-driven workflow. Each impurity is profiled for structural alerts and scored for bacterial mutagenicity, the results land in a classification, and the whole run keeps a versioned trail you can hand to a reviewer or rerun a year later unchanged.

## Key facts
- **1:1** — reproducible: same inputs, same call
- **Two** — complementary (Q)SAR reads per impurity
- **Versioned** — audit trail on every run

## From synthetic route to control strategy

### A workflow built for M7
Flow runs the assessment as a structured template, one of the custom workflows Insilica hand-builds around a customer's process.

### Structural-alert profiling
The QSAR Toolbox flags DNA-reactive alerts and groups impurities for read-across against the regulatory reference.

### Mutagenicity prediction
ToxJobs scores bacterial mutagenicity with models like AMESformer, giving the second (Q)SAR read M7 calls for.

### Ask the evidence directly
Sage lets a reviewer interrogate any impurity call in plain language and read the citations behind it.

## Related platform tools
- [Flow](https://toxindex.com/platform/flow.md): Reproducible workflow engine
- [ToxJobs](https://toxindex.com/platform/toxjobs.md): Prediction toolkit
- [Sage](https://toxindex.com/platform/sage.md): Conversational answer engine

## Related solutions
- [Pharmaceuticals](https://toxindex.com/solutions/pharmaceuticals.md): Drug development & impurities
- [New chemical assessment](https://toxindex.com/solutions/new-chemical-assessment.md): Novel substances
- [REACH registration](https://toxindex.com/solutions/reach-compliance.md): REACH & CLP

## Frequently asked questions

**How does ToxIndex handle ICH M7?**

Flow runs the assessment as an ontology-driven workflow: each impurity is profiled for structural alerts and scored for bacterial mutagenicity, results land in a control classification, and the whole run keeps a versioned audit trail.

**Does it provide the two (Q)SAR methodologies M7 asks for?**

Yes. Structural-alert profiling through the QSAR Toolbox and a statistical mutagenicity prediction through ToxJobs give the two complementary (Q)SAR reads M7 calls for, with expert review on top.

**Can an auditor reproduce an impurity call?**

The same inputs always produce the same call, and the versioned trail lets a reviewer rerun the assessment a year later unchanged.

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Canonical page: https://toxindex.com/solutions/ich-m7-mutagenic-impurities