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Dexamethasone acetate
| ITEMS | LIMIT | |
| Ph.Eur.5 | USP30 | |
| Appearance | A white or almost white, crystalline powder | |
| Identification | A. IR Absorption | A. IR Absorption |
| B. TLC | B. UV Absorption | |
| Specific optical rotation | Between +84°and +90° | Between +82°and +88° |
| Related substances | Any individual impurity not more than 0.5% | Any individual impurity not more than 1.0% |
| Total impurities not more 1.0% | Total impurities not more 2.0% | |
| Loss on drying | Not more than 0.5% | Not more than 0.4% |
| Residue on ignition | Not more than 0.1% | |
| Residual solvents | Acetone≤5000ppm | |
| Ethyl acetate≤5000ppm | ||
| Pyridine≤200ppm | ||
| Assay | Between 97.0% and 103.0% | Between 97.0% and 102.0% |
| Heavy metals | Not more than 0.002% | |
| Micronization | 90% not more than 15 microns | |
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