Temperature excursion: difference between revisions
Diff·revision 50 → 51·11:42, 21 Dec 2025
Difference between revision 50 and revision 51 of Temperature excursion. 2 lines changed; the page grew by 555 bytes.
| Revision 50 — 16:44, 14 Dec 2025 CarryOverCai (talk) reorder sections to follow the class template 21,564 bytes +1,287 | Revision 51 — 11:42, 21 Dec 2025 A1c_Alder (talk) replace bare ref with full citation 22,119 bytes +555 | ||
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| 138 | * do orthogonal methods agree, since a single chromatographic method may be blind to a physical change that a size-exclusion or particulate method detects.{{r|manning2010}} | 138 | * do orthogonal methods agree, since a single chromatographic method may be blind to a physical change that a size-exclusion or particulate method detects.{{r|manning2010}} |
| 139 | 139 | ||
| + | 140 | Two limitations are structural. Without a pre-excursion result for the same lot, a purity figure establishes only the current state, not a change; the retained sample is therefore the critical asset, and its absence is what most often makes a post-hoc assessment impossible. And a method's limit of detection sets a floor below which no statement can be made: an assay resolving 0.1% of a degradation product cannot demonstrate the absence of 0.05%, and a report of no detected change means no change above that floor rather than no change.{{r|ich_q1a}} | |
| + | 141 | ||
| 140 | == References == | 142 | == References == |
| 141 | {{reflist}} | 143 | {{reflist}} |