Limit of detection: difference between revisions
Diff·revision 6 → 7·19:52, 11 Nov 2024
Difference between revision 6 and revision 7 of Limit of detection. 12 lines changed; the page grew by 920 bytes.
| Revision 6 — 07:17, 22 Oct 2024 NewLabNell (talk) correct the integration description — valley-to-valley, not drop-line 2,589 bytes ±0 | Revision 7 — 19:52, 11 Nov 2024 IsocraticIla (talk) sentence case in headings per PP:MOS 3,509 bytes +920 | ||
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| 19 | The limit is a property of the method as applied, not of the technique. The same instrument with a longer injection, a more concentrated preparation or a more sensitive detector setting has a different limit.{{r|usp621}} | 19 | The limit is a property of the method as applied, not of the technique. The same instrument with a longer injection, a more concentrated preparation or a more sensitive detector setting has a different limit.{{r|usp621}} |
| 20 | 20 | ||
| + | 21 | == Reporting thresholds == | |
| + | 22 | In pharmaceutical practice the reporting threshold — the level above which an impurity must appear in a report — is set by guidance according to the daily dose, and is distinct from the detection limit. A method must be able to detect below the reporting threshold; a method that cannot is inadequate regardless of how good its other characteristics are.{{r|ich_q3a}} | |
| + | 23 | ||
| + | 24 | | Term | Meaning | | |
| + | 25 | |---|---| | |
| + | 26 | | Detection limit | Presence can be distinguished from background | | |
| + | 27 | | Quantitation limit | A number can be reported with acceptable precision | | |
| + | 28 | | Reporting threshold | Level above which an impurity must be listed | | |
| + | 29 | | Identification threshold | Level above which an impurity must be identified | | |
| + | 30 | | Qualification threshold | Level above which safety must be addressed | | |
| + | 31 | ||
| 21 | == References == | 32 | == References == |
| 22 | {{reflist}} | 33 | {{reflist}} |
| 23 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> | 34 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> |
| + | 35 | <ref name="ich_q3a">International Council for Harmonisation, ''Q3A(R2): Impurities in New Drug Substances'' (2006).</ref> | |
| 24 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 36 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 25 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> | 37 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> |