Deamidation: difference between revisions
Diff·revision 21 → 22·15:42, 4 Oct 2025
Difference between revision 21 and revision 22 of Deamidation. 2 lines changed; the page grew by 302 bytes.
| Revision 21 — 09:43, 8 Sep 2025 CategoryBot (talk) bot: normalise citation format 4,961 bytes ±0 | Revision 22 — 15:42, 4 Oct 2025 DiffWatchDov (talk) state the titration endpoint and the reagent factor 5,263 bytes +302 | ||
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| 33 | For material held outside a controlled cold chain the practical significance is that a purity figure determined at release does not describe a vial that has since spent time warm and in solution. See [[Temperature excursion]] and [[Chain of custody]] — a low purity figure on community-tested material may be characterising storage rather than manufacture. | 33 | For material held outside a controlled cold chain the practical significance is that a purity figure determined at release does not describe a vial that has since spent time warm and in solution. See [[Temperature excursion]] and [[Chain of custody]] — a low purity figure on community-tested material may be characterising storage rather than manufacture. |
| 34 | 34 | ||
| + | 35 | A method described as stability-indicating must resolve deamidated species from the parent; that is one of the things forced degradation demonstrates. A certificate making the claim without the supporting work is asserting rather than evidencing it. See [[Analytical method validation]].{{r|ich_q1a}} | |
| + | 36 | ||
| 35 | == References == | 37 | == References == |
| 36 | {{reflist}} | 38 | {{reflist}} |