Table 2. Preparation of series standard solutions for anti-Xa factor potency assay of enoxaparin sodium.
This table provides the detailed preparation scheme for the series of standard solutions used in the anti-Xa factor potency assay. The standard solutions were prepared by diluting the low molecular weight heparin biological reference standard (Batch No. 11, EDQM) to achieve the desired concentrations for calibration and validation experiments. The table includes information on the reference standard potency, dilution volumes, and final concentrations.
| ID | Labeled activity (IU/mL) | Be diluted (mL) | Diluents (mL) | |||
|---|---|---|---|---|---|---|
| Standard S | 110 | 1.0 ml of water R for reconstitution | ||||
| SC0 | 11 | Standard S | 1.0 | + | Water R | 9.0 |
| SC1 | 1.0 | SC0 Solution | 0.1 | + | Water R | 1.0 |
| S1 | 0.16 | SC2 Solution | 0.16 | + | pH7.4 | 0.84 |
| S2 | 0.12 | S1 Solution | 0.75 | + | pH7.4 | 0.25 |
| S3 | 0.09 | S2 Solution | 0.75 | + | pH7.4 | 0.25 |
| S4 | 0.0675 | S3 Solution | 0.75 | + | pH7.4 | 0.25 |
| SCMax | 0.192 | SC2 Solution | 0.192 | + | pH7.4 | 0.808 |
| SCMin | 0.054 | SC2 Solution | 0.054 | + | pH7.4 | 0.946 |