Table 7. Accuracy evaluation of the anti-Xa factor potency assay for enoxaparin sodium test samples (activity units: IU/mL).
| ID | Measured activity | Standard added value | Measured activity after addition | Recovery rate | RSD |
|---|---|---|---|---|---|
| SP1 (Initial) | 102.36 IU/mg | / | 105.94 IU/ml | / | 1.2% |
| PB1 (Spiking 1) | / | 110 IU/ml | 107.67 IU/ml | 99.45% | |
| PB2 (Spiking 2) | / | 110 IU/ml | 107.13 IU/ml | 98.47% | |
| PB3 (Spiking 3) | / | 110 IU/ml | 108.01 IU/ml | 100.07% | |
| PB4 (Spiking 4) | / | 110 IU/ml | 108.31 IU/ml | 100.62% | |
| PB5 (Spiking 5) | / | 110 IU/ml | 108.97 IU/ml | 101.82% | |
| PB6 (Spiking 6) | / | 110 IU/ml | 108.55 IU/ml | 101.05% |