Hydrocortisone Acetate
Quality standard:
USP25
Identification:
A: Infrared Absorption
B: Ultraviolet Absorption
Specific rotation :between +158°and +165°
Loss on drying:≤ 1.0 %
Residue on ignition: negligible from 100mg
Chromatographic Purity:
Individual purity≤1.0%
Total purity≤2.0%
Assay: 97%~102%
Items | Standards | Results |
Appearance | A white or almost white, crystalline powder | Almost white crystalline powder |
Identification |
| Complies Complies |
Specific rotation | +158°~ +167°(Ph.Eur.) | +162.7° |
Loss on Drying | ≤0.5%(Ph.Eur.)
| 0.2% |
Related Substance
| Single impurities: ≤1.0% Total impurities: ≤ 1.5% Not more than one impurity is greater than 0.5% | 0.39% 1.31% 0 |
Assay
|
97.0%~103.0%
|
100.0%
|
Particle size(In-house) | 90%≤30microns | Complies |
