Table 4. Robustness results of the anti-Xa factor potency assay for enoxaparin sodium under varying experimental conditions.
| ID | Measured activity (IU/mg) | Dry matter potency (IU/mg) | RSD compared to P0 |
|---|---|---|---|
| P0 (Initial) | 102.36 | 106.51 | / |
| P1 (+2 °C) | 101.08 | 105.18 | 0.9% |
| P2 (−2 °C) | 102.42 | 106.58 | 0.04% |
| P3 (+15 s) | 100.99 | 105.09 | 0.10% |
| P4 (−15 s) | 101.40 | 105.52 | 0.07% |
| P0hr | 100.04 | 104.01 | RSD compared to P0hr |
| P24hr | 100.36 | 106.51 | 1.6% |