Analytical method validation: difference between revisions
Diff·revision 15 → 16·16:15, 9 Mar 2025
Difference between revision 15 and revision 16 of Analytical method validation. 2 lines changed; the page grew by 421 bytes.
| Revision 15 — 03:03, 11 Feb 2025 SigFigSindri (talk) add the ionisation mode to the mass-spectrometry description 4,021 bytes ±0 | Revision 16 — 16:15, 9 Mar 2025 UnderfillUna (talk) add the cross-link to the compendial chapter 4,442 bytes +421 | ||
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| 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}} | 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 | 34 | ||
| + | 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 | ||
| 35 | == References == | 37 | == References == |
| 36 | {{reflist}} | 38 | {{reflist}} |