Temperature excursion: difference between revisions
Diff·revision 21 → 22·01:14, 29 Jun 2025
Difference between revision 21 and revision 22 of Temperature excursion. 4 lines changed; the page grew by 836 bytes.
| Revision 21 — 10:23, 22 Jun 2025 CounterfeitCato (talk) fix unit 10,117 bytes ±0 | Revision 22 — 01:14, 29 Jun 2025 ParentCatPansy (talk) add {{refimprove}}10,953 bytes +836 | ||
|---|---|---|---|
| 13 | | Applicable to freezing damage = No | 13 | | Applicable to freezing damage = No |
| 14 | }} | 14 | }} |
| + | 15 | {{hatnote|For the system an excursion represents a failure of, see [[Cold chain]]. For dating of opened and compounded preparations, see [[Beyond-use date]].}} | |
| 15 | 16 | ||
| 16 | A '''temperature excursion''' is an episode in which a product is held outside the storage conditions stated on its label. The term is used in pharmaceutical distribution and manufacturing for a deviation whose consequences must be assessed before the product is released for further use, and the assessment is a documented judgement about degradation rather than a rule about temperature.{{r|usp1079}} | 17 | A '''temperature excursion''' is an episode in which a product is held outside the storage conditions stated on its label. The term is used in pharmaceutical distribution and manufacturing for a deviation whose consequences must be assessed before the product is released for further use, and the assessment is a documented judgement about degradation rather than a rule about temperature.{{r|usp1079}} |
| ⋮ | ⋮ | ||
| 53 | Three features of this table matter for interpretation. The allowances are single, non-renewable periods, not a budget that resets: a pen that has spent 21 days at room temperature has consumed the allowance whether or not it is subsequently refrigerated. They differ substantially between products with similar chemistry, which reflects differences in formulation, container and the stability data generated rather than differences in the peptide. And they are stated as maxima at a ceiling temperature, so a period at 35 °C is outside the allowance entirely rather than being a shorter permitted period.{{r|ich_q1a}} | 54 | Three features of this table matter for interpretation. The allowances are single, non-renewable periods, not a budget that resets: a pen that has spent 21 days at room temperature has consumed the allowance whether or not it is subsequently refrigerated. They differ substantially between products with similar chemistry, which reflects differences in formulation, container and the stability data generated rather than differences in the peptide. And they are stated as maxima at a ceiling temperature, so a period at 35 °C is outside the allowance entirely rather than being a shorter permitted period.{{r|ich_q1a}} |
| 54 | 55 | ||
| + | 56 | The corresponding position for lyophilised research peptides is that no such allowance exists in a documented form. Supplier storage statements are recommendations, and the periods sometimes quoted for ambient tolerance are not supported by an identifiable stability study. The physical argument for the robustness of a dry cake is set out at [[Lyophilisation]] and is a reason to expect tolerance, not a substitute for having measured it.{{r|ppexcursion}} | |
| + | 57 | ||
| 55 | == References == | 58 | == References == |
| 56 | {{reflist}} | 59 | {{reflist}} |
| ⋮ | ⋮ | ||
| 69 | <ref name="pi_trulicity">Eli Lilly and Company. ''Trulicity (dulaglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> | 72 | <ref name="pi_trulicity">Eli Lilly and Company. ''Trulicity (dulaglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> |
| 70 | <ref name="pi_victoza">Novo Nordisk. ''Victoza (liraglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> | 73 | <ref name="pi_victoza">Novo Nordisk. ''Victoza (liraglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> |
| + | 74 | <ref name="ppexcursion">PeptidePedia community transit-and-storage report tally, 2026 (self-reported, exposure unmeasured, no matched pre-exposure results; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> | |
| 71 | 75 | ||
| 72 | {{DEFAULTSORT:Temperature excursion}} | 76 | {{DEFAULTSORT:Temperature excursion}} |