Bibliographic record
ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline 2023
§1Bibliographic record
§1.1Record
- Authors
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- Title
- ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
- Source
- ICH Harmonised Guideline
- Year
- 2023
- Volume, issue, pages
- Step 4 version
- Digital object identifier
- not held by the Institute
- PubMed identifier
- not held by the Institute
- Record type
- Guideline
- Institute identifier
- CEI-BR-045
§1.2Institute documents citing this record
Table 1. Documents in the Institute set that cite this record.
| Document | Series |
|---|---|
| Monograph: Danuglipron | Compound monograph |
| Monograph: 5-amino-1MQ | Compound monograph |
| Standard CEI-MS-12: Residual solvent determination by static headspace gas chromatography | Methodological standard |
| 3 citing documents. | |
§1.3Subject tags
impurities genotoxic ich
Compound Evidence Institute · CEI-BR-045 · https://compoundevidence.com/bibliography/ichm7/ · retrieved 30 July 2026