Temperature excursion: difference between revisions
Diff·revision 54 → 55·11:34, 18 Jan 2026
Difference between revision 54 and revision 55 of Temperature excursion. 2 lines changed; the page grew by 309 bytes.
| Revision 54 — 04:31, 12 Jan 2026 CrudePeptidePearl (talk) expand §Degradation kinetics 23,647 bytes +670 | Revision 55 — 11:34, 18 Jan 2026 ResinRhoswen (talk) update infobox 23,956 bytes +309 | ||
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| 128 | Two structural features of this sequence are worth noting. It is asymmetric in favour of rejection, because the burden is to show that quality is unaffected rather than to show that it is affected. And it depends at step 4 on data that exist only for products with a stability programme, which is why the sequence cannot be applied outside regulated distribution however carefully the temperature was recorded.{{r|ich_q1a}} | 128 | Two structural features of this sequence are worth noting. It is asymmetric in favour of rejection, because the burden is to show that quality is unaffected rather than to show that it is affected. And it depends at step 4 on data that exist only for products with a stability programme, which is why the sequence cannot be applied outside regulated distribution however carefully the temperature was recorded.{{r|ich_q1a}} |
| 129 | 129 | ||
| + | 130 | Cumulative accounting is the step most often omitted. A consignment may pass three separate excursion assessments individually and fail the same criteria when the exposures are summed, and guidance is explicit that the accounting is cumulative across the product's life rather than per event.{{r|whotrs961}} | |
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| 130 | === What a stability-indicating assay is asked to demonstrate === | 132 | === What a stability-indicating assay is asked to demonstrate === |
| 131 | A ''stability-indicating'' method is one shown to resolve the intact substance from its degradation products, so that a change in the assay result can be attributed to degradation rather than to variability. Demonstrating that property is a validation exercise, and the demonstration is conventionally made by forced degradation: the substance is deliberately stressed by heat, humidity, acid, base, oxidant and light, and the method is shown to separate and quantify what results, with mass balance accounted for.{{r|ich_q1a,manning2010}} | 133 | A ''stability-indicating'' method is one shown to resolve the intact substance from its degradation products, so that a change in the assay result can be attributed to degradation rather than to variability. Demonstrating that property is a validation exercise, and the demonstration is conventionally made by forced degradation: the substance is deliberately stressed by heat, humidity, acid, base, oxidant and light, and the method is shown to separate and quantify what results, with mass balance accounted for.{{r|ich_q1a,manning2010}} |