Temperature excursion: difference between revisions
Diff·revision 11 → 12·13:47, 18 Jul 2025
Difference between revision 11 and revision 12 of Temperature excursion. 16 lines changed; the page grew by 574 bytes.
| Revision 11 — 11:28, 8 Jul 2025 RepackRadek (talk) add the collapse-temperature point, sourced 11,765 bytes +812 | Revision 12 — 13:47, 18 Jul 2025 MicrodoseMagnus (talk) close an unbalanced quotation mark 12,339 bytes +574 | ||
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| 13 | | Rate multiplier per 10 K near 25 °C = approximately 3 | 13 | | Rate multiplier per 10 K near 25 °C = approximately 3 |
| 14 | | Applicable to freezing damage = No | 14 | | Applicable to freezing damage = No |
| + | 15 | <!-- Assessment inputs --> | |
| + | 16 | | Primary evidence = ICH Q1A(R2) stability data for the product | |
| + | 17 | | Confirmatory testing = Stability-indicating assay | |
| + | 18 | | Cumulative accounting = Time out of refrigeration, summed across events | |
| + | 19 | | Governing chapters = USP <659>, USP <1079> | |
| 15 | }} | 20 | }} |
| 16 | {{hatnote|For the system an excursion represents a failure of, see [[Cold chain]]. For dating of opened and compounded preparations, see [[Beyond-use date]].}} | 21 | {{hatnote|For the system an excursion represents a failure of, see [[Cold chain]]. For dating of opened and compounded preparations, see [[Beyond-use date]].}} |
| ⋮ | ⋮ | ||
| 57 | 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}} | 62 | 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}} |
| 58 | 63 | ||
| + | 64 | {{seealso|Cold chain|Peptide stability table}} | |
| + | 65 | ||
| 59 | == Quantifying an excursion == | 66 | == Quantifying an excursion == |
| 60 | Where an excursion consists of warming, its cumulative effect is summarised by the mean kinetic temperature. For intervals of duration ''t''<sub>i</sub> at absolute temperatures ''T''<sub>i</sub>: | 67 | Where an excursion consists of warming, its cumulative effect is summarised by the mean kinetic temperature. For intervals of duration ''t''<sub>i</sub> at absolute temperatures ''T''<sub>i</sub>: |
| ⋮ | ⋮ | ||
| 70 | {{math|(96 × 22 + 624 × 5) ÷ 720 = (2112 + 3120) ÷ 720 = 7.27 °C}} | 77 | {{math|(96 × 22 + 624 × 5) ÷ 720 = (2112 + 3120) ÷ 720 = 7.27 °C}} |
| 71 | 78 | ||
| + | 79 | which lies inside the labelled range. The mean kinetic temperature, however, weights by degradation. With T = 295.15 K and 278.15 K: | |
| + | 80 | ||
| 72 | == References == | 81 | == References == |
| 73 | {{reflist}} | 82 | {{reflist}} |
| ⋮ | ⋮ | ||
| 87 | <ref name="pi_victoza">Novo Nordisk. ''Victoza (liraglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> | 96 | <ref name="pi_victoza">Novo Nordisk. ''Victoza (liraglutide) injection'' — United States prescribing information, current revision, section on storage and handling.</ref> |
| 88 | <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> | 97 | <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> |
| + | 98 | ||
| + | 99 | == See also == | |
| + | 100 | * [[Cold chain]] | |
| + | 101 | * [[Peptide stability table]] | |
| + | 102 | * [[Beyond-use date]] | |
| + | 103 | * [[Deamidation]] | |
| + | 104 | * [[Methionine oxidation]] | |
| 89 | 105 | ||
| 90 | {{DEFAULTSORT:Temperature excursion}} | 106 | {{DEFAULTSORT:Temperature excursion}} |