Analytical method validation: difference between revisions
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| Revision 5 — 23:58, 28 Aug 2024 AnalyticalAnnie (talk) add the counterion determination method by name 2,439 bytes ±0 | Revision 6 — 12:57, 13 Sep 2024 CiteBot (talk) bot: repair redlinked category 2,979 bytes +540 | ||
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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 | For peptides the critical characteristic is specificity — the ability to determine the analyte in the presence of everything else that may be there. Peptide impurities are structurally close to the peptide, so a method that separates the analyte from unrelated substances may still fail to separate it from a deletion sequence differing by one residue.{{r|usp1503}} | |
| + | 13 | ||
| 12 | == The characteristics == | 14 | == The characteristics == |
| 13 | | Characteristic | Question it answers | | 15 | | Characteristic | Question it answers | |
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| 28 | {{reflist}} | 30 | {{reflist}} |
| 29 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> | 31 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> |
| + | 32 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 30 | <ref name="usp1225">United States Pharmacopeia, General Chapter <1225>, ''Validation of Compendial Procedures''.</ref> | 33 | <ref name="usp1225">United States Pharmacopeia, General Chapter <1225>, ''Validation of Compendial Procedures''.</ref> |
| 31 | 34 | ||
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| 33 | [[Category:Method validation]] | 36 | [[Category:Method validation]] |
| 34 | [[Category:Analytical methods]] | 37 | [[Category:Analytical methods]] |
| + | 38 | [[Category:Analytical science]] | |
| 35 | 39 |