Analytical method validation: difference between revisions
Diff·revision 17 → 18·18:47, 21 Apr 2025
Difference between revision 17 and revision 18 of Analytical method validation. 5 lines changed; the page grew by 611 bytes.
| Revision 17 — 19:50, 29 Mar 2025 Areapercent_Ayo (talk) fix indentation in the source 4,442 bytes ±0 | Revision 18 — 18:47, 21 Apr 2025 ArchiveBot (talk) bot: flag bare reference 5,053 bytes +611 | ||
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| 35 | The peptide-specific difficulty is that the closest impurities are the most likely. A deletion sequence missing one residue, a peptide with one residue oxidised, a [[Deamidation|deamidated]] variant — all are structurally similar to the parent and may elute within a fraction of a minute of it. Resolving them requires a gradient with adequate duration and shallowness, which is precisely what a short run sacrifices. | 35 | The peptide-specific difficulty is that the closest impurities are the most likely. A deletion sequence missing one residue, a peptide with one residue oxidised, a [[Deamidation|deamidated]] variant — all are structurally similar to the parent and may elute within a fraction of a minute of it. Resolving them requires a gradient with adequate duration and shallowness, which is precisely what a short run sacrifices. |
| 36 | 36 | ||
| + | 37 | == What validation does not establish == | |
| + | 38 | Validation is about the method, not about the material or the sample. A fully validated method applied to a non-representative sample produces a precise, accurate and irrelevant number. See [[Blind sampling]].{{r|ich_q2}} | |
| + | 39 | ||
| + | 40 | Nor does it transfer between laboratories automatically. A method validated in one laboratory and run in another requires verification that it performs equivalently there — the same characteristics, demonstrated locally. Two laboratories running "the same" method may differ in column lot, instrument dwell volume and mobile-phase preparation. | |
| + | 41 | ||
| 37 | == References == | 42 | == References == |
| 38 | {{reflist}} | 43 | {{reflist}} |