Temperature excursion: difference between revisions
Diff·revision 8 → 9·05:18, 5 May 2025
Difference between revision 8 and revision 9 of Temperature excursion. 4 lines changed; the page grew by 1,019 bytes.
| Revision 8 — 15:27, 1 May 2025 CrudePeptidePearl (talk) split overlong sentence 4,790 bytes ±0 | Revision 9 — 05:18, 5 May 2025 RetatrutideRuben (talk) label community tally as self-reported 5,809 bytes +1,019 | ||
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| 24 | The three can disagree, and the disagreement is informative rather than paradoxical. A brief excursion may be a compliance failure while producing degradation far below the detection limit of any available assay; conversely a profile within the permitted band may still cause measurable change in a product whose stability is marginal. Assessment practice therefore uses all three: compliance to determine whether an investigation is required, kinetics to predict, and testing to confirm.{{r|usp1079,waterman2005}} | 24 | The three can disagree, and the disagreement is informative rather than paradoxical. A brief excursion may be a compliance failure while producing degradation far below the detection limit of any available assay; conversely a profile within the permitted band may still cause measurable change in a product whose stability is marginal. Assessment practice therefore uses all three: compliance to determine whether an investigation is required, kinetics to predict, and testing to confirm.{{r|usp1079,waterman2005}} |
| 25 | 25 | ||
| + | 26 | An excursion is also not a single class of event. Warming above the labelled range and cooling below it have different mechanisms and are not interchangeable in an assessment, because freezing damage is not governed by the Arrhenius relationship on which the warming arithmetic depends. Guidance for products labelled 2–8 °C accordingly treats a freezing event as a separate category, often with a stricter disposition, and freeze indicators exist precisely because the mean kinetic temperature calculation cannot detect the event.{{r|matthias2007,bhatnagar2007}} | |
| + | 27 | ||
| 26 | == References == | 28 | == References == |
| 27 | {{reflist}} | 29 | {{reflist}} |
| ⋮ | ⋮ | ||
| 32 | <ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01).</ref> | 34 | <ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01).</ref> |
| 33 | <ref name="waterman2005">Waterman KC, Adami RC. "Accelerated aging: prediction of chemical stability of pharmaceuticals." ''International Journal of Pharmaceutics'' 293(1–2):101–125 (2005).</ref> | 35 | <ref name="waterman2005">Waterman KC, Adami RC. "Accelerated aging: prediction of chemical stability of pharmaceuticals." ''International Journal of Pharmaceutics'' 293(1–2):101–125 (2005).</ref> |
| + | 36 | <ref name="bhatnagar2007">Bhatnagar BS, Bogner RH, Pikal MJ. "Protein stability during freezing: separation of stresses and mechanisms of protein stabilization." ''Pharmaceutical Development and Technology'' 12(5):505–523 (2007).</ref> | |
| + | 37 | <ref name="matthias2007">Matthias DM, Robertson J, Garrison MM, Newland S, Nelson C. "Freezing temperatures in the vaccine cold chain: a systematic literature review." ''Vaccine'' 25(20):3980–3986 (2007).</ref> | |
| 34 | 38 | ||
| 35 | {{DEFAULTSORT:Temperature excursion}} | 39 | {{DEFAULTSORT:Temperature excursion}} |