Bacterial endotoxin test: difference between revisions
Diff·revision 19 → 20·08:48, 20 Jun 2025
Difference between revision 19 and revision 20 of Bacterial endotoxin test. 5 lines changed; the page grew by 660 bytes.
| Revision 19 — 13:35, 29 May 2025 StubSorterBot (talk) bot: flag bare reference 4,428 bytes ±0 | Revision 20 — 08:48, 20 Jun 2025 PatientPanelPru (talk) expand §Why it matters for peptide material 5,088 bytes +660 | ||
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| 28 | For comparison, the compendial limit for most parenteral products corresponds to 5 EU per kilogram of body weight per hour, translated into a per-milligram limit by the maximum dose. A figure quoted in EU/mg without the dose basis cannot be compared against that limit by a reader.{{r|usp1503}} | 28 | For comparison, the compendial limit for most parenteral products corresponds to 5 EU per kilogram of body weight per hour, translated into a per-milligram limit by the maximum dose. A figure quoted in EU/mg without the dose basis cannot be compared against that limit by a reader.{{r|usp1503}} |
| 29 | 29 | ||
| + | 30 | == What the result does and does not establish == | |
| + | 31 | A low endotoxin figure establishes that the sample tested contained little detectable lipopolysaccharide. It does not establish sterility — see [[Sterility testing]] — and does not address non-endotoxin pyrogens, which the test does not detect at all.{{r|usp85}} | |
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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. | |
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| 30 | == References == | 35 | == References == |
| 31 | {{reflist}} | 36 | {{reflist}} |