Genotoxic Impurity Profiling

Screening synthetic impurities for genotoxic structural alerts under ICH M7 and deriving the Threshold of Toxicological Concern

Current Stage

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TTC threshold

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Structural alerts

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Ames test

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Allowed conc.

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Max Daily Dose (drug product)500 mg

Treatment Duration (LTL staging)1–12 months

Genotoxic alert substructure

(Q)SAR scan beam

Neutral scaffold atoms

TTC threshold line

Cleared / below TTC