LAL Endotoxin Test System — Technical Specification¶
1. Technical Parameters¶
| Parameter | Specification |
|---|---|
| Method | Gel-clot or chromogenic |
| Incubation Temperature | 37 ± 1 °C |
| Incubation Time | 60 ± 2 min |
| Sensitivity Range | 0.005 – 0.5 EU/mL |
| LAL Reagent | Certified for sensitivity |
| CSE (Control Standard Endotoxin) | E. coli O113:H10 |
| Plate/ Tube Reader | 340 – 405 nm (chromogenic) |
2. Acceptance Criteria¶
| Test | Acceptance |
|---|---|
| Negative Control | No gel / <0.005 EU/mL |
| Positive Control (2λ) | Gel / >0.005 EU/mL |
| Spike Recovery | 50 – 200% |
| Sample pH | 6.0 – 8.0 |