Cold chain: difference between revisions
Diff·revision 34 → 35·15:44, 12 Dec 2025
Difference between revision 34 and revision 35 of Cold chain. 2 lines changed; the page grew by 567 bytes.
| Revision 34 — 20:21, 20 Nov 2025 LCellLeif (talk) correct the eutectic temperature — source gives a range 26,583 bytes ±0 | Revision 35 — 15:44, 12 Dec 2025 SupplyWatchSuri (talk) add the note that lyophilised material tolerates excursions better than solution 27,150 bytes +567 | ||
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| 167 | USP <1079> approaches the same ground from the compendial side, describing risks in storage and transport and mitigation strategies, and it is the chapter in which mean kinetic temperature and the treatment of excursions are elaborated for United States practice. USP <1118> covers the monitoring devices themselves.{{r|usp1079,usp1118}} | 167 | USP <1079> approaches the same ground from the compendial side, describing risks in storage and transport and mitigation strategies, and it is the chapter in which mean kinetic temperature and the treatment of excursions are elaborated for United States practice. USP <1118> covers the monitoring devices themselves.{{r|usp1079,usp1118}} |
| 168 | 168 | ||
| + | 169 | The stability data that make any of this meaningful come from the ICH stability programme. A labelled storage statement is an inference from long-term, intermediate and accelerated stability studies conducted under defined conditions, and the permitted in-use periods and excursion allowances quoted on labels are supported by those studies rather than by general principle. A product with no such programme has a storage recommendation and not a storage specification, which is the fundamental asymmetry between regulated and unregulated distribution.{{r|ich_q1a}} | |
| + | 170 | ||
| 169 | == References == | 171 | == References == |
| 170 | {{reflist}} | 172 | {{reflist}} |