CAS number： 50-02-2
Molecular formula： C22H29FO5
molecular weight： 392.4611
Chemical structure：
|
Product |
DEXAMETHASONE BASE | |
|
Shelf Life |
5 years |
|
|
ITEM |
SPECIFICATION | RESULT |
|
CHARACTER |
WHITE OR ALMOST WHITE CRYSTALLINE POWDER | ALMOST WHITE CRYSTALLINE POWDER |
| SPECIFIC ROTATION |
+72° TO +80° |
+76.2° |
| IDENTIFICATION | （1）COMPLIES BY IR | CONFORMS |
| （2）UV:△E/ERS ≤3.0% | 1.8% | |
|
TEST |
||
|
CHROMATOGRAPHIC PURITY |
PRINCIPAL IMPURITY NOT MORE THAN 1.0% | 0.13% |
| TOTAL IMPURITIES NOT MORE THAN 2.0% | 0.43% | |
|
LOSS ON DRYING |
NOT MORE THAN 0.5% | 0.09% |
| RESIDUE ON IGNITION | NOT MORE THAN 0.2% | 0.07% |
|
RESIDUAL SOLVENT |
CHLOROFORM NOT MORE THAN 60ppm | NOT DETECTED |
| METHANOL NOT MORE THAN 1000ppm | 220ppm | |
| ETHYL ACETATE NOT MORE THAN 300ppm | 22ppm | |
| ASSAY | CONTAINS 97.0% TO 102.0% OF C22H29FO5 CALCULATED ON DRIED BASIS | 100.1% |
| CONCLUSION |
THE PRODUCT CONFORMS TO USP39 |
|