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 |