| Product | DEXAMETHASONE SODIUM PHOSPHATE | |
| Shelf Life | 3 years | |
| Item | Specification | Result |
| CHARACTER | WHITE OR ALMOST WHITE POWDER | ALMOST WHITE POWDER |
| IDENTIFICATION | （1）COMPLIES BY IR | CONFORMS |
| （2）COMPLIES BY TLC | CONFORMS | |
| TEST | ||
| APPEARANCE OF SOLUTION | CLEAR AND NOT MORE INTENSELY COLURED THAN REFERENCE SOLUTION B7 | CONFORMS |
| PH | 7.5 TO 9.5 | 8.2 |
| SPECIFIC ROTATION | +75° TO +83° | +79.8° |
| RELATED SUBSTANCES | ||
| CHROMATOGRAPHIC PURITY | PRINCIPAL IMPURITY ≤0.5% | 0.09% |
| TOTAL IMPURITIES ≤1.0% | 0.45% | |
| INORGANIC PHOSPHATES | ≤1.0% | ＜1.0% |
| RESIDUAL SOLVENT | ETHANOL ≤5000ppm | NOT DETECTED |
| ETHANOL AND WATER | ≤13.0% | 4.1% |
| ASSAY |
CONTAINS 97.0% TO 103.0% OF C22H28FNa2O8P CALCULATED WITH ANHYDROUS ETHANOL-FREE |
100.6% |
| CONCLUSION: THE PRODUCT CONFORMS TO CORPORATION STANDARD 2 (EP5-EP6/BP2005-BP2010)AND CUSTOMER STANDARD. | ||