| Product Name | Methyl Prednisolone | |
| Shelf Life | 2 years | |
| Specification | USP38 | |
| Item | Specification | Result |
| Character | White to almost white crystalline powder | Almost white crystalline powder |
| Specific Optical Rotation | +79° to +86° | +83.6° |
| Identification | (1)Complies by IR | Conforms |
| (2)△E/E85≤3.0% | 0.4% | |
| (3)Positive reaction | Positive | |
| Test | Individual impurity not more than 1.0% | 0.26% |
| Total impurities not more than 2.0% | 0.99% | |
| Residue on ignition | Not more than 0.2% | 0.08% |
| Loss on drying | Not more than 1.0% | 0.5% |
| Residual solvent | Methnol not more than 3000ppm | 2ppm |
| Ethanol not more than 5000ppm | 1327ppm | |
| Acetone not more than 5000ppm | 1ppm | |
| Ethyl Acetate nor more than 5000ppm | 2ppm | |
| Assay | Contains 97.0% to 103.0% of C22H30O5 calculated on the dried basis | 99.8% |
| Particle Size | It should be 90% below 20um | 13.22um |