Temperature excursion: difference between revisions
Diff·revision 17 → 18·02:47, 9 Jun 2025
Difference between revision 17 and revision 18 of Temperature excursion. 5 lines changed; the page grew by 832 bytes.
| Revision 17 — 11:57, 4 Jun 2025 PrepHPLC_Pia (talk) fix category — parent was wrong 9,285 bytes ±0 | Revision 18 — 02:47, 9 Jun 2025 StopperingSteff (talk) add see also 10,117 bytes +832 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Temperature excursion | 2 | | name = Temperature excursion |
| + | 3 | | image = cold-chain.svg | |
| + | 4 | | caption = An excursion is defined against a labelled range, so the same profile may be an excursion for one product and compliant for another. | |
| 3 | | Definition = Deviation outside labelled storage conditions | 5 | | Definition = Deviation outside labelled storage conditions |
| 4 | | Assessed by = Duration, magnitude and cumulative exposure | 6 | | Assessed by = Duration, magnitude and cumulative exposure |
| ⋮ | ⋮ | ||
| 49 | Allowances are as stated in the respective prescribing information and differ between jurisdictions; the figures above follow United States labelling and are cited to the labels rather than to secondary summaries.{{r|pi_ozempic,pi_wegovy,pi_mounjaro,pi_trulicity,pi_victoza}} | 51 | Allowances are as stated in the respective prescribing information and differ between jurisdictions; the figures above follow United States labelling and are cited to the labels rather than to secondary summaries.{{r|pi_ozempic,pi_wegovy,pi_mounjaro,pi_trulicity,pi_victoza}} |
| 50 | 52 | ||
| + | 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 | ||
| 51 | == References == | 55 | == References == |
| 52 | {{reflist}} | 56 | {{reflist}} |
| ⋮ | ⋮ | ||
| 71 | [[Category:Peptide degradation]] | 75 | [[Category:Peptide degradation]] |
| 72 | [[Category:Logistics]] | 76 | [[Category:Logistics]] |
| + | 77 | [[Category:Clinical practice]] | |
| 73 | 78 |