Cold-chain freight: difference between revisions
Diff·revision 17 → 18·06:48, 8 Sep 2025
Difference between revision 17 and revision 18 of Cold-chain freight. 3 lines changed; the page grew by 388 bytes.
| Revision 17 — 04:09, 20 Aug 2025 FlowTrialFraser (talk) add the data-logger point: an unlogged shipment has no excursion record 4,370 bytes ±0 | Revision 18 — 06:48, 8 Sep 2025 CrudePeptidePearl (talk) add the stopper material, since it affects moisture ingress 4,758 bytes +388 | ||
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| 39 | This is not a reason to disregard the cold chain, but it does bear on interpretation. An unfavourable [[Third-party testing|independent result]] on material shipped without temperature control is weak evidence about the supplier, because the material's history is unknown — the asymmetry described at [[Chain of custody]]. | 39 | This is not a reason to disregard the cold chain, but it does bear on interpretation. An unfavourable [[Third-party testing|independent result]] on material shipped without temperature control is weak evidence about the supplier, because the material's history is unknown — the asymmetry described at [[Chain of custody]]. |
| 40 | 40 | ||
| + | 41 | The stability statement on a [[Certificate of analysis|certificate]] is written against a named storage condition. A material stored or shipped outside that condition is outside the statement, and the certificate does not describe it.{{r|usp1503}} | |
| + | 42 | ||
| 41 | == References == | 43 | == References == |
| 42 | {{reflist}} | 44 | {{reflist}} |
| ⋮ | ⋮ | ||
| 44 | <ref name="usp1079">United States Pharmacopeia, General Chapter <1079>, ''Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products''.</ref> | 46 | <ref name="usp1079">United States Pharmacopeia, General Chapter <1079>, ''Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products''.</ref> |
| 45 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 47 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 48 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 46 | 49 | ||
| 47 | == See also == | 50 | == See also == |