Trace Impurity to Threshold

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Classifying a trace impurity under ICH M7(R2) hinges on a structural alert, an Ames result, a carcinogenicity finding, and dosing duration. Enter what you know, and this tool returns the hazard class, the acceptable intake and its basis, the specification limit at your daily dose, and how the threshold shifts from Phase 1 to commercial use. Each output cites its guideline section, so the reasoning can be checked rather than trusted.

It is an educational instrument. It carries no expert review and is not a toxicological risk assessment.