Temperature excursion: difference between revisions
Diff·revision 24 → 25·00:52, 14 Jul 2025
Difference between revision 24 and revision 25 of Temperature excursion. 5 lines changed; the page grew by 262 bytes.
| Revision 24 — 01:09, 7 Jul 2025 ResinRhoswen (talk) ce, tighten prose 11,765 bytes +812 | Revision 25 — 00:52, 14 Jul 2025 CouplingCillian (talk) add hatnote 12,027 bytes +262 | ||
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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]].}} |