Prednisolone-21-acetate
Items | Specifications | Results |
Character | White or almost white crystallin powder | Almost white crystalline powder |
Specific rotation | +112°~+119° | +118.3° |
Identification | 1) Complies by IR | Conforms |
2) Complies by UV not more than 2.5% | 1.20% | |
3) Positive reaction | Conforms | |
Chromatographic purity | Principal impurity not more than 1.0% | 0.32% |
Total impurities not more than 2.0% | 0.69% | |
Methanol | ≤3000ppm | 438ppm |
Pyridine | ≤200ppm | 31ppm |
Loos on drying | Not more than 1.0% | 0.10% |
Assay | Contains 97.0% to 102.0% of C23H306 calculated on dried basis | 100.40% |