Bibliographic record
ICH Q1A(R2) Stability Testing of New Drug Substances and Products
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline 2003
§1Bibliographic record
§1.1Record
- Authors
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- Title
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- Source
- ICH Harmonised Tripartite Guideline
- Year
- 2003
- 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-046
§1.2Institute documents citing this record
Table 1. Documents in the Institute set that cite this record.
| Document | Series |
|---|---|
| Monograph: NAD+ (nicotinamide adenine dinucleotide) | Compound monograph |
| Monograph: Glutathione | Compound monograph |
| Standard CEI-MS-04: Determination of water content in lyophilised peptides by coulometric… | Methodological standard |
| Standard CEI-MS-13: Development and validation of a stability-indicating method for… | Methodological standard |
| Standard CEI-MS-09: Assessment of appearance, cake integrity and reconstitution behaviour | Methodological standard |
| Standard CEI-MS-20: Photostability assessment of light-sensitive peptides | Methodological standard |
| Standard CEI-MS-21: Freeze–thaw and in-use stability assessment of reconstituted peptide… | Methodological standard |
| Synthesis: In-use stability of reconstituted peptide solutions | Evidence synthesis |
| 8 citing documents. | |
§1.3Subject tags
stability ich
Compound Evidence Institute · CEI-BR-046 · https://compoundevidence.com/bibliography/ichq1a/ · retrieved 30 July 2026