| Product Name | BETAMETHASONE BASE | |
| Shelf life | 3 years | |
| ITEM | SPECIFICATION | RESULT |
| CHARACTER | WHITE OR ALMOST WHITE CRYSTALLINE POWDER | ALMOST WHITE CRYSTALLINE POWDER |
| SPECIFIC ROTATION | +118° TO +126° | +123.6° |
| IDENTIFICATION | （1）COMPLIES BY IR | CONFORMS |
| （2）COMPLIES BY TLC | CONFORMS | |
| CHROMATOGRAPHIC PURITY | PRINCIPAL IMPURITY NOT MORE THAN 1.0% | 0.34% |
| 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% |
| PARTICLE SIZE (VOLUME METHOD) | IT SHOULD BE 90% BELOW 20μm | 7.19μm |
| ASSAY | CONTAINS 97.0% TO 103.0% OF C22H29FO3 CALCULATED ON DRIED BASIS | 99.2% |
| CONCLUSION | THE PRODUCT CONFORMS TO EP8.0 | |