Peptide stability table: difference between revisions
Diff·revision 47 → 48·07:15, 13 Oct 2025
Difference between revision 47 and revision 48 of Peptide stability table. 10 lines changed; the page grew by 1,110 bytes.
| Revision 47 — 21:08, 2 Oct 2025 ArchiveBot (talk) bot: update parent category chain 5,688 bytes ±0 | Revision 48 — 07:15, 13 Oct 2025 MarginNoteMars (talk) add confidence interval 6,798 bytes +1,110 | ||
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| 44 | {{figure|cold-chain|Nominal storage conditions describe one segment of a chain in which exposure accumulates.}} | 44 | {{figure|cold-chain|Nominal storage conditions describe one segment of a chain in which exposure accumulates.}} |
| 45 | 45 | ||
| + | 46 | == What this table does not tell you == | |
| + | 47 | It does not tell a reader whether a specific vial is sound. Stability data describes a formulation under conditions; it says nothing about a particular container that has been through an unknown distribution history. Nor does it address: | |
| + | 48 | ||
| + | 49 | * '''sterility''', which is a property of the process and container-closure integrity, tested under [[USP General Chapter 71|USP <71>]] rather than by a stability study;{{r|usp71b}} storage and packaging requirements are set out separately again;{{r|usp659}} | |
| + | 50 | * '''endotoxin''', which does not decrease on storage and is tested under [[USP General Chapter 85|USP <85>]]; | |
| + | 51 | * '''identity''', which is what [[Mass spectrometry|mass spectrometry]] establishes and no stability figure implies; | |
| + | 52 | * '''the label claim''', which is a [[Peptide content|mass-balance]] question. | |
| + | 53 | ||
| 46 | == References == | 54 | == References == |
| 47 | {{reflist}} | 55 | {{reflist}} |
| 48 | <ref name="ich">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | 56 | <ref name="ich">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> |
| 49 | <ref name="manning">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). DOI:10.1007/s11095-009-0045-6. PMID 20143256.</ref> | 57 | <ref name="manning">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). DOI:10.1007/s11095-009-0045-6. PMID 20143256.</ref> |
| + | 58 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> | |
| + | 59 | <ref name="usp71b">United States Pharmacopeia, General Chapter <71>, "Sterility Tests". USP–NF, current revision.</ref> | |
| 50 | 60 | ||
| 51 | == Further reading == | 61 | == Further reading == |