Methylprednisolone(83-43-2)
Product Description
● Methylprednisolone, an organic compound, is a medium-acting glucocorticoid with strong anti-inflammatory effects.
● Methylprednisolone is used for emergency treatment of critical diseases and also for endocrine disorders, rheumatic diseases, collagenous diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, blood diseases, leukemia, shock, cerebral edema, polyneuritis, myelitis and prevention of vomiting caused by cancer chemotherapy. Currently, it is mainly used in clinical practice for organ transplantation.
● Quality Standard: USP
| Product | Methylprednisolone | Manufacturing date | 2017.05.15 |
| Batch No. | NXEMP 170601 | Report date | 2017.06.14 |
| Criteria | EP 8.0 | Retest date | 2019.05.15 |
| Specification | Result | ||
| Characteristic | A white or almost white, crystalline powder | White crystalline powder | |
| Identification | A(IR), B(HPLC) | Conforms | |
| Specific optical rotation | +97.0° 〜+103.0° | +99.7° | |
| Related substances | Total impurities < 2.0%
Impurity A < 0.3% Impurity B < 0.2% Impurity C < 0.15% Impurity D (D isomerl and D isomer2)< 0.5% Impurity E < 0.15% Impurity H < 0.2% The sum of impurities G and I < 0.3% Unspecified impurities < 0.10% |
Total: 0.14%<0.05%0.08%<0.05%D isomerl :<0.05%D isomer2:<0.05%<0.05%<0.05%<0.05%Conforms | |
| Loss on drying | <1.0% | 0.16% | |
| Assay | 97.0% ~ 102.0% | 100.8% | |
| Residual solvents | Dichloromethane < 600ppmMethanol < 3000ppm | 73ppm249ppm | |
| Batch size | 72.3kg | ||
| Quantity | 72.3kg | ||
| Conclusion | The above product conforms to EP8.0 | ||
