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生产厂家厂商性质
济南市所在地
Product Name(名称) | FAVIPIRAVIR 法匹拉韦 | |
CAS No. | 259793-96-9 | |
Batch No.(批号) | 20200310 | |
Report Date(报告日期) | 20200310 | |
Perform Standard(执行标准) | Enterprise Standard(企标) | |
Items(项目) | Standards(标准) | Results(分析结果) |
Character (性状) | off-white to yellow powder 类白色至黄色粉末 | Conform 符合规定 |
Solubility (溶解度) | Soluble in DMSO | Conform 符合规定 |
Water (水分) | ≤1.0% |
0.1%
|
PH | 3.0-5.0 | 3.8 |
Identification (鉴别) | HPLC/IR | Conform 符合规定 |
Related Substances (有关物质) | Single Impurities单项杂质 :≤0.2% | 0.03% |
| Total unknown impurity总杂质 :≤0.5% | 0.11% |
Residual solvents (残留溶剂) | Ethanol≤5000ppm | ND |
| Mthanol≤3000ppm | 175ppm |
| Ethyl acetate≤5000ppm | 565ppm |
Heavy metals (重金属) | ≤10ppm | Conform 符合规定 |
Residue on ignition (炽灼残渣) | ≤0.5% | 0.1% |
Loss on drying (干燥失重) | ≤0.5% | 0.19% |
Assay (含量) | 98%-102% | 99.9% |