Endotoxin Concentrations and Mean Percentages of Spike (Positive Product Control; PPC) Recovery (As a Percentage of Recovery from Water) for Each of the Four Assays with the Four Products (Product A, Unheated). The Results Shown Are the Average Results from Three Independent Runs by Two Technologists
| Assay | ||||||||
|---|---|---|---|---|---|---|---|---|
| KQCL | ENDOSAFE-MCS | ENDOZYME II | ENDOLISA | |||||
| EU/mL | PPC (%) | EU/mL | PPC (%) | EU/mL | PPC (%) | EU/mL | PPC (%) | |
| Unspiked products | ||||||||
| Product A | <0.5 | 100 | <5 | 161 | 36 | 106 | 0.7 | 135 |
| Product B | <0.5 | 109 | <5 | 159 | <0.5 | 109 | <0.5 | 120 |
| Product C | 10 | 93 | <5 | 139 | <50 | 93 | <5 | 99 |
| Product D | <0.5 | 68 | <5 | 115 | <12.5 | 99 | <5 | 84 |
| Spiked products | ||||||||
| RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) | RSE recovery (%) | PPC (%) | |
| Product A | 125 | 74 | 107 | 176 | 84 | 89 | 82 | 137 |
| Product B | 196 | 78 | 136 | 163 | 182 | 74 | 107 | 93 |
| Product C | 142 | 87 | 114 | 162 | 133 | 95 | 93 | 98 |
| Product D | 79 | 57 | 92 | 144 | 148 | 97 | 90 | 91 |