产品名(PRODUCT NAME): 泊马度胺Pomalidomide | |||
批号(BATCH NO.):2017081901 | 数量(QUANTITY):5KG | ||
检验日期(CHECKING DATE):2017-08-20 | 报告日期(REPORT DATE): 2017-08-22 | ||
生产日期(MANUFACTURE DATE): 2017-08-19 | 有效日期(EXPIRY DATE): 2019-08-18 | ||
执行标准(Perform standard):企业标准(Enterprise Standard) | |||
分析项目 ITEM OF ANALYSIS | 指标 STANDARD | 分析结果 RESULT OF ANALYSIS | |
性状Appearance | 黄色粉末 yellow solid powder | 符合规定 Conforms | |
鉴别 Identification | (1) MS (2) IR | 符合规定 Conforms | |
残留溶剂 Solvent residue | 甲醇methanol≤4000ppm | 未检出 ND | |
乙醇ethano≤5000ppm | 178ppm | ||
乙酸乙酯Ethyl acetate≤4000ppm | 未检出 ND | ||
丙酮 Acetone≤1000ppm | 未检出 ND | ||
重金属Heavy metals | ≤10ppm | 符合规定 Conforms | |
含量Assay | ≥99.0% | 99.85% | |
水分Water | ≤1.0% | 符合规定 Conforms | |
单一杂质Single impurity | ≤0.1% | 0.09% | |
总杂质Total impurities | ≤1.0% | 0.19% | |
炽灼残渣Residue on Ignition | ≤0.1% | 符合规定Conforms | |
结论Conclusion | 符合企业标准Conforms to Enterprise Standard | ||
化验者(ANALYST) Zhang Yang 复核者(CHECKER) Liu Yi |