Temperature excursion: difference between revisions
Diff·revision 4 → 5·07:10, 23 Apr 2025
Difference between revision 4 and revision 5 of Temperature excursion. 3 lines changed; the page grew by 716 bytes.
| Revision 4 — 07:47, 20 Apr 2025 FreightFenna (talk) convert list to prose 3,272 bytes ±0 | Revision 5 — 07:10, 23 Apr 2025 SupplyWatchSuri (talk) de-orphan 3,988 bytes +716 | ||
|---|---|---|---|
| 20 | ; The analytical framing : Can any change be measured? This is answered by testing, and is a question about method capability. | 20 | ; The analytical framing : Can any change be measured? This is answered by testing, and is a question about method capability. |
| 21 | 21 | ||
| + | 22 | 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}} | |
| + | 23 | ||
| 22 | == References == | 24 | == References == |
| 23 | {{reflist}} | 25 | {{reflist}} |
| ⋮ | ⋮ | ||
| 26 | <ref name="whotrs961">World Health Organization. "Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products." ''WHO Technical Report Series'' No. 961, Annex 9 (2011).</ref> | 28 | <ref name="whotrs961">World Health Organization. "Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products." ''WHO Technical Report Series'' No. 961, Annex 9 (2011).</ref> |
| 27 | <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> | 29 | <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> |
| + | 30 | <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> | |
| 28 | 31 | ||
| 29 | {{DEFAULTSORT:Temperature excursion}} | 32 | {{DEFAULTSORT:Temperature excursion}} |