Results of the Product-specific Method Validations Using rFC Reagent for the Detection of Bacterial Endotoxins in Various Pharmaceutical Products
| Sample Type | Compendia Inhibition/Enhancement | Compendia pH | Accuracy | Precision | ||||
|---|---|---|---|---|---|---|---|---|
| %PPC Lot 1 | %PPC Lot 2 | %PPC Lot 3 | pH1 | High (average) | Low (average) | High (average) | Low (average) | |
| Insulin Solution | 90% | 98% | 101% | Pass | 92% | 89% | 6% | 9% |
| Insulin Solution | 100% | 99% | 95% | Pass | 90% | 88% | 9% | 10% |
| Insulin Solution | 93% | 90% | 90% | Pass | 87% | 90% | 11% | 19% |
| MAb DS | 99% | 95% | 98% | Pass | 107% | 98% | 4% | 10% |
| MAb DP | 104% | 96% | 102% | Pass | 102% | 102% | 12% | 13% |
| MAb DS | 93% | 96% | 94% | Pass | 90% | 77% | 4% | 5% |
| MAb DP | 80% | 93% | 90% | Pass | 86% | 80% | 4% | 6% |
| MAb DS | 90% | 93% | 94% | Pass | 86% | 85% | 13% | 13% |
| MAb DP | 98% | 112% | 105% | Pass | 106% | 101% | 7% | 9% |
| MAb DP | 106% | 107% | 106% | Pass | 101% | 95% | 6% | 8% |
| MAb DS | 101% | 100% | 98% | Pass | 104% | 81% | 5% | 20% |
| MAb DP | 103% | 107% | 117% | Pass | 105% | 101% | 6% | 9% |
| MAb DP | 102% | 93% | 105% | Pass | 89% | 87% | 10% | 10% |
| MAb DS | 94% | 91% | 97% | Pass | 98% | 84% | 5% | 19% |
| MAb DP | 95% | 102% | 99% | Pass | 88% | 80% | 12% | 19% |
| MAb DS | 109% | 112% | 111% | Pass | 107% | 96% | 7% | 3% |
| Excipient | 114% | 117% | 119% | Pass | 111% | 93% | 4% | 3% |
| Excipient | 90% | 95% | 91% | Pass | 94% | 90% | 8% | 6% |
| Water: rFC Supplier 12 | 93% | 114% | 112% | Pass | 100% | 116% | 4% | 12% |
| Water: rFC Supplier 22 | 88% | 89% | 90% | Pass | 117% | 112% | 7% | 9% |
| Water: rFC Supplier 13 | 87% | 98% | 102% | Pass | 99% | 83% | 10% | 6% |
| Averages | 98% | 92% | 9% | 11% | ||||