Table 1. Preparation of series test solutions for anti-Xa factor potency assay of enoxaparin sodium.
This table outlines the detailed preparation scheme for the series of test solutions used in the anti-Xa factor potency assay. The solutions were prepared by diluting the initial enoxaparin sodium samples to achieve the desired concentrations for validation experiments. The table includes information on sample weights, estimated potency, dilution volumes, and final concentrations. Since the test sample is in solid form, the initial concentration of the solution may vary slightly due to differences in the precise weighing during sample preparation. Consequently, the volume of the initial solution required to prepare the 11 IU/mL TC0 solution may fluctuate, as indicated by the variable volume of 0.124 mL marked with an asterisk (*) in the table.
| ID | Estimated activity (IU/mL) | Be diluted (mL) | Diluents (mL) | |||
|---|---|---|---|---|---|---|
| Test sample T | 100.25 | / | ||||
| TC0 | 11 | Test Sample T | 0.124* | + | Water R | 1.0 |
| TC1 | 1.0 | TC0 Solution | 0.1 | + | Water R | 1.0 |
| T1 | 0.16 | TC2 Solution | 0.16 | + | pH7.4 | 0.84 |
| T2 | 0.12 | T1 Solution | 0.75 | + | pH7.4 | 0.25 |
| T3 | 0.09 | T2 Solution | 0.75 | + | pH7.4 | 0.25 |
| T4 | 0.0675 | T3 Solution | 0.75 | + | pH7.4 | 0.25 |
Note:
Abbreviations: pH7.4, Tris (hydroxymethyl)aminomethane sodium chloride buffer solution pH7.4. Water R, Reagent Water, which is a high-purity water that complies with pharmacopoeial standards and is suitable for use in experiments and assays, as opposed to ordinary water.