Deamidation: difference between revisions
Diff·revision 17 → 18·03:28, 6 Jul 2025
Difference between revision 17 and revision 18 of Deamidation. 6 lines changed; the page grew by 742 bytes.
| Revision 17 — 19:39, 18 Jun 2025 ResolutionRoo (talk) add the repeatability figure with the number of injections 4,219 bytes ±0 | Revision 18 — 03:28, 6 Jul 2025 ColumnOvenCoy (talk) add the forced-degradation conditions the claim rests on 4,961 bytes +742 | ||
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| 28 | Because deamidation is slow at low temperature and in the solid state, it is largely a solution-phase problem. A [[Lyophilisation|lyophilised]] peptide stored cold deamidates very slowly; the same peptide in solution at ambient temperature can accumulate a measurable fraction over weeks. This is a principal reason for the [[Beyond-use date|beyond-use dating]] of reconstituted material.{{r|ich_q1a}} | 28 | Because deamidation is slow at low temperature and in the solid state, it is largely a solution-phase problem. A [[Lyophilisation|lyophilised]] peptide stored cold deamidates very slowly; the same peptide in solution at ambient temperature can accumulate a measurable fraction over weeks. This is a principal reason for the [[Beyond-use date|beyond-use dating]] of reconstituted material.{{r|ich_q1a}} |
| 29 | 29 | ||
| + | 30 | == Relevance to incretin peptides == | |
| + | 31 | Several therapeutic peptides in this field contain asparagine or glutamine residues, so deamidation is a specified degradation product in their stability programmes. Whether a given deamidated species retains activity is sequence-specific and is established experimentally rather than predicted.{{r|usp1503}} | |
| + | 32 | ||
| + | 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 | ||
| 30 | == References == | 35 | == References == |
| 31 | {{reflist}} | 36 | {{reflist}} |
| ⋮ | ⋮ | ||
| 41 | * [[Temperature excursion]] | 46 | * [[Temperature excursion]] |
| 42 | * [[Beyond-use date]] | 47 | * [[Beyond-use date]] |
| + | 48 | * [[Analytical method validation]] | |
| 43 | 49 | ||
| 44 | {{DEFAULTSORT:Deamidation}} | 50 | {{DEFAULTSORT:Deamidation}} |