Analytical method validation: difference between revisions
Diff·revision 2 → 3·05:45, 5 Aug 2024
Difference between revision 2 and revision 3 of Analytical method validation. 13 lines changed; the page grew by 725 bytes.
| Revision 2 — 08:44, 28 Jul 2024 DiluentDiya (talk) de-duplicate a repeated sentence 1,373 bytes ±0 | Revision 3 — 05:45, 5 Aug 2024 ResinRhoswen (talk) state that ultraviolet response is not uniform across impurities 2,098 bytes +725 | ||
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| 10 | The characteristics assessed are specificity, linearity, range, accuracy, precision (repeatability and intermediate precision), the detection and quantitation limits where relevant, and robustness. Which of these apply depends on what the method is for, and the compendial treatment of the same subject is framed the same way.{{r|ich_q2,usp1225}} | 10 | The characteristics assessed are specificity, linearity, range, accuracy, precision (repeatability and intermediate precision), the detection and quantitation limits where relevant, and robustness. Which of these apply depends on what the method is for, and the compendial treatment of the same subject is framed the same way.{{r|ich_q2,usp1225}} |
| 11 | 11 | ||
| + | 12 | == The characteristics == | |
| + | 13 | | Characteristic | Question it answers | | |
| + | 14 | |---|---| | |
| + | 15 | | Specificity | Does the method measure the analyte and not something else? | | |
| + | 16 | | Linearity | Is response proportional to concentration over the range? | | |
| + | 17 | | Range | Between what limits is the method demonstrated to work? | | |
| + | 18 | | Accuracy | Does the result agree with the true value? | | |
| + | 19 | | Repeatability | Do replicate determinations agree within a run? | | |
| + | 20 | | Intermediate precision | Do they agree across days, analysts and instruments? | | |
| + | 21 | | [[Limit of detection]] | Below what level is presence undetectable? | | |
| + | 22 | | Quantitation limit | Below what level is a number unreliable? | | |
| + | 23 | | Robustness | Does the result survive small deliberate changes in conditions? | | |
| + | 24 | ||
| 12 | == References == | 25 | == References == |
| 13 | {{reflist}} | 26 | {{reflist}} |