Bacterial endotoxin test: difference between revisions
Diff·revision 12 → 13·18:44, 26 Jan 2025
Difference between revision 12 and revision 13 of Bacterial endotoxin test. 2 lines changed; the page grew by 296 bytes.
| Revision 12 — 20:16, 8 Jan 2025 INN_Ingrid (talk) expand §Methods 4,102 bytes +123 | Revision 13 — 18:44, 26 Jan 2025 BiosimilarBoaz (talk) add the note on co-elution and what it hides 4,398 bytes +296 | ||
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| 26 | Lyophilised research peptides are not manufactured as parenteral products and are not required to meet a parenteral endotoxin limit. Some certificates report endotoxin nonetheless; many do not. Absence of the determination is not evidence of a problem, and its presence is not evidence that the material is suitable for any particular purpose. | 26 | Lyophilised research peptides are not manufactured as parenteral products and are not required to meet a parenteral endotoxin limit. Some certificates report endotoxin nonetheless; many do not. Absence of the determination is not evidence of a problem, and its presence is not evidence that the material is suitable for any particular purpose. |
| 27 | 27 | ||
| + | 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 | ||
| 28 | == References == | 30 | == References == |
| 29 | {{reflist}} | 31 | {{reflist}} |