Bacterial endotoxin test: difference between revisions
Diff·revision 23 → 24·18:36, 22 Sep 2025
Difference between revision 23 and revision 24 of Bacterial endotoxin test. 2 lines changed; the page grew by 229 bytes.
| Revision 23 — 12:18, 2 Sep 2025 ChromCleanupCass (talk) add the plate-count expression and define its terms 5,088 bytes ±0 | Revision 24 — 18:36, 22 Sep 2025 ReceptorRhoda (talk) state that ultraviolet response is not uniform across impurities 5,317 bytes +229 | ||
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| 33 | Nor does it transfer between vials. Endotoxin contamination is frequently heterogeneous, arising from a particular piece of equipment or a particular fill, so a determination on one unit constrains other units only through the assumption of lot uniformity that the whole apparatus of [[Lot traceability|lot traceability]] exists to support. | 33 | Nor does it transfer between vials. Endotoxin contamination is frequently heterogeneous, arising from a particular piece of equipment or a particular fill, so a determination on one unit constrains other units only through the assumption of lot uniformity that the whole apparatus of [[Lot traceability|lot traceability]] exists to support. |
| 34 | 34 | ||
| + | 35 | The general caution about detection limits applies here too: "not detected" means below the sensitivity of the method used, and the method sensitivity is a field the report should state. See [[Limit of detection]].{{r|usp1503}} | |
| + | 36 | ||
| 35 | == References == | 37 | == References == |
| 36 | {{reflist}} | 38 | {{reflist}} |