Analytical method validation: difference between revisions
Diff·revision 11 → 12·05:52, 19 Dec 2024
Difference between revision 11 and revision 12 of Analytical method validation. 12 lines changed; the page grew by 992 bytes.
| Revision 11 — 14:27, 29 Nov 2024 FootnoteFyfe (talk) give the limit of quantitation with the signal-to-noise ratio it assumes 3,011 bytes +32 | Revision 12 — 05:52, 19 Dec 2024 Chromatokid (talk) add the detection wavelength 4,003 bytes +992 | ||
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| 28 | Robustness is the characteristic most relevant to reading a third-party result. A method sensitive to a two-degree change in column temperature or a small change in mobile-phase pH will give different answers in different laboratories, and a difference between two results may reflect that rather than a difference in material.{{r|ich_q2}} | 28 | Robustness is the characteristic most relevant to reading a third-party result. A method sensitive to a two-degree change in column temperature or a small change in mobile-phase pH will give different answers in different laboratories, and a difference between two results may reflect that rather than a difference in material.{{r|ich_q2}} |
| 29 | 29 | ||
| + | 30 | == Specificity for peptides == | |
| + | 31 | Specificity is demonstrated by showing that the analyte peak is resolved from known related substances, from process impurities, and from degradation products generated by forced degradation.{{r|usp1503}} | |
| + | 32 | ||
| + | 33 | Forced degradation is the part most often omitted outside licensed manufacture. Deliberately stressing the material with heat, light, acid, base and oxidant generates the degradation products the method must be able to see, and a method that cannot resolve them is not stability-indicating. A certificate describing its method as stability-indicating is making a claim that forced degradation supports; one that does not make the claim leaves the question open.{{r|ich_q1a}} | |
| + | 34 | ||
| 30 | == References == | 35 | == References == |
| 31 | {{reflist}} | 36 | {{reflist}} |
| 32 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> | 37 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> |
| 33 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 38 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 39 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | |
| 34 | <ref name="usp1225">United States Pharmacopeia, General Chapter <1225>, ''Validation of Compendial Procedures''.</ref> | 40 | <ref name="usp1225">United States Pharmacopeia, General Chapter <1225>, ''Validation of Compendial Procedures''.</ref> |
| + | 41 | ||
| + | 42 | == See also == | |
| + | 43 | * [[Limit of detection]] | |
| + | 44 | * [[Reference standard]] | |
| + | 45 | * [[High-performance liquid chromatography]] | |
| + | 46 | * [[Area percent purity]] | |
| 35 | 47 | ||
| 36 | {{DEFAULTSORT:Analytical method validation}} | 48 | {{DEFAULTSORT:Analytical method validation}} |