ICH Q3A (Impurities in New Drug Substances)
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
ICH guideline
|
| gptkbp:appliesTo |
new chemical entities
|
| gptkbp:compatibleWith |
biotechnological/biological products
excipients |
| gptkbp:defines |
identification threshold
qualification threshold reporting threshold |
| gptkbp:firstIssueDate |
1995
|
| gptkbp:focusesOn |
impurities in new drug substances
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q3A (Impurities in New Drug Substances)
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:latestReleaseVersion |
2006
ICH Q3A(R2) |
| gptkbp:purpose |
harmonize requirements for impurities in new drug substances
|
| gptkbp:relatedGuideline |
ICH Q3B (Impurities in New Drug Products)
ICH Q3C (Impurities: Guideline for Residual Solvents) |
| gptkbp:scope |
residual solvents
inorganic impurities organic impurities |
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities |
| gptkbp:bfsParent |
gptkb:ICH_Guidelines
|
| gptkbp:bfsLayer |
7
|