Results From One Assay for Samples of Product A (No Pretreatment or Heated to 75°C for 15 min) without and with an Endotoxin Spike
| KQCL | ENDOSAFE-MCS | ENDOZYME II | ENDOLISA | |||||
|---|---|---|---|---|---|---|---|---|
| Unspiked | Results (EU/mL) | PPC (%) | Results (EU/mL) | PPC (%) | Results (EU/mL) | PPC (%) | Results (EU/mL) | PPC (%) |
| Product A | <0.5 | 100 | <5 | 195 | 31 | 100 | 0.6 | 133 |
| Heated Product A | <0.5 | 110 | <5 | 135 | <0.5 | 100 | <0.5 | 128 |
| Spiked | RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) |
| Product A | 118 | 86 | 109 | 188 | 78 | 79 | 72 | 124 |
| Heated Product A | 41 | 99 | 27 | 132 | 1 | 101 | 1 | 72 |