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东康源的甲泼尼龙琥珀酸2921-57-5原粉质量怎么样？用检测数据说话
质检单
CERTIFICATE OF ANALYSIS
|
品名 Product Name |
Methylpredmisolone hemisuccinate |
数量 Quantity |
20kg |
|
批号 Batch no |
191201 |
包装 Packing |
5kg/袋 |
|
生产日期 Produce Date |
2019年12月08号 |
报告日期 Report Date |
2019年12月11日 |
|
检验依据 Ref.Standard |
USP34标准 USP34 Standard |
|
检验项目及结果 Item and Results |
| Item | Specification | Results of Analysis |
| Description | White or almost white hygroscopic Powder | White hygroscopic Powder |
| Identification |
A:IR B:UV |
Conform |
| Specific Rotation | +87°~+95° | +91.8° |
| Loss On Drying | ≤1.0% | 0.1% |
| Residue on ignition | ≤0.2% | 0.07% |
| Chromatographic purity |
Any individual impurity≤1.0% Total impurities≤2.0% |
0.29% 0.72% |
| Assay | 97.0%-103.0% | 99.4% |
| Residual solvents |
Methanol≤3000ppm Ethanol≤5000ppm Dichloromethane≤600ppm Acetone≤5000ppm |
420ppm 2200ppm 120ppm 520ppm |
| Conclusion | The specification conform with USP34 |
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