Free tool
ICH impurity limits,
calculated from the dose
Enter a maximum daily dose and get the thresholds that follow from ICH M7(R2), Q3A(R2) or Q3B(R2) — read from the guideline tables, not from memory.
What this calculates
- ICH M7(R2) — the staged-TTC acceptable limit for an impurity already classified as needing TTC-based control, banded by duration of treatment.
- ICH Q3A(R2) — reporting, identification and qualification thresholds for organic impurities in a new drug substance.
- ICH Q3B(R2) — the same three thresholds for degradation products in a new drug product.
What it does not
It performs no hazard assessment. It will not tell you whether an impurity is mutagenic, run a (Q)SAR or Ames evaluation, identify a cohort-of-concern compound, categorise a nitrosamine under the CPCA, or model a purge factor. Each of those is a judgement about a specific molecule in a specific process, and each is part of an assessment rather than a calculation.
See what an assessment covers →Nothing entered here is stored. The figures are returned for screening and orientation; a limit cited in a regulatory submission should come from an assessment that records its own basis.