Verification policy
Molicheck ties calculator limits and wording to identifiable primary documents — ICH, EMA, FDA, and USP references — not to unofficial summaries. Each row below is the same record used in tool disclaimers and search listings (rules version 1.56). The same data is available as a machine-readable list.
We verify links and document metadata against the issuer's publication, then record a last checked calendar date. We re-check every source at least every 90 days, including a link check. When a guideline updates, we change the registry, publish a changelog entry, and bump the rules version.
Source registry
| Issuer | Document | Version | Doc date | Last checked | Link | Used by |
|---|---|---|---|---|---|---|
| EMA | Appendix 2 — Carcinogenic Potency Categorisation Approach | EMA/451665/2023 | 2023-10-12 | 2026-10-16 | EMA Appendix 2 CPCA (EMA/451665/2023, 12 Oct 2023) | |
| FDA | Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities | Aug 2023 | 2023-08-04 | 2026-10-17 | FDA Recommended AI Limits for NDSRIs (Aug 2023) | |
| FDA | CDER Nitrosamine Impurity Acceptable Intake Limits | Updated information (living list) | 2026-09-24 | 2026-10-17 | FDA CDER nitrosamine impurity AI limits (updated lists) | |
| EMA | Questions and answers for MAHs/applicants on the CHMP Opinion for the Article 5(3) referral on nitrosamine impurities in human medicinal products | EMA/409815/2020 Rev.23 | 2025-10-10 | 2026-10-17 | EMA nitrosamine Q&A (EMA/409815/2020 Rev.23, 10 Oct 2025) | |
| ICH | Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk | M7(R2) | 2023-04-03 | 2026-10-17 | ICH M7(R2) | |
| ICH | Impurities: Guideline for Residual Solvents | Q3C(R9) | 2024-01-24 | 2026-10-17 | ICH Q3C(R9) Residual Solvents (minor revision 2024) | |
| EMA | ICH Q3C(R9) residual solvents scientific guideline | Q3C(R9) | 2024-04-29 | 2026-10-17 | EMA ICH Q3C residual solvents scientific guideline | |
| USP | Residual Solvents | <467> (official 1 Aug 2025) | 2025-08-01 | 2026-10-17 | USP <467> Residual Solvents |
Rules version 1.56. Machine-readable list.
Disclaimer
This table is for transparency and planning. It does not replace reading the official text, your quality system, or advice from the applicable authority. Compound-specific acceptable intakes and local pharmacopoeia requirements may differ from the defaults shown on individual calculators.
See also the regulatory data changelog for dated releases.