Identification threshold
The level above which an impurity must be structurally identified rather than merely quantified. ICH Q3A sets it by daily dose.
Related terms
- Reporting threshold
- The area percent below which peaks are not reported. The index uses 0.05 %. Excluded peaks are excluded from the total, so purity is systematically overstated by their sum.
- Qualification threshold
- The level above which an impurity must be shown to be biologically qualified. Not applicable to research material and included here for completeness.
see also Peak integration · Identification threshold
see also Identification threshold
Where this term appears
The glossary exists to make record pages readable without a chemistry degree. Every technical term on a report resolves here.
- Assay report records — the term appears in result tables, peak tables and provenance blocks
- Method references — where the measurement behind the term is defined
- All 13 glossary terms beginning with I