Endotoxin Testing¶
Bacterial Endotoxins (LAL Test)¶
Principle¶
The Limulus Amebocyte Lysate (LAL) test detects bacterial endotoxins using amebocyte lysate from horseshoe crab blood.
Methods¶
| Method | Sensitivity | Application |
|---|---|---|
| Gel-clot | 0.03 EU/mL | Semi-quantitative |
| Turbidimetric | 0.001–0.1 EU/mL | Quantitative |
| Chromogenic | 0.001–0.1 EU/mL | Quantitative, automated |
Acceptance Criteria¶
| Application | Limit |
|---|---|
| Research peptides | ≤10 EU/mg |
| Injectable-grade | ≤5 EU/kg body weight/day |
| GMP/clinical | Per pharmacopeia (USP <85>) |
Why It Matters¶
Endotoxins from Gram-negative bacteria can cause pyrogenic reactions (fever, inflammation) if injected. All peptides intended for in vivo use must be tested.
- Bacterial Endotoxins (LAL Test) — Review the section above for key parameters, methods, and quality criteria.
- Acceptance Criteria — Review the section above for key parameters, methods, and quality criteria.
Key Takeaways¶
- Bacterial Endotoxins (LAL Test) — Review the section above for key parameters, methods, and quality criteria.
- Acceptance Criteria — Review the section above for key parameters, methods, and quality criteria.
- Why It Matters — See the section above for detailed parameters and specifications.
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