分析项目 ITEM OF ANALYSIS |
指标 STANDARD |
外观 Appearance |
类白色到白色粉末固体 White to almost white powder |
鉴别 Identification |
符合LC-MS检测 Conforms LC-MS test |
符合1HNMR检测 Conforms 1HNMR TEST |
|
单一杂质 Individual impurity |
≤0.5% |
水分 Water |
≤0.5% |
纯度 Purity |
≥99.0% |
结论Conclusion |
符合企业标准Conforms to Enterprise Standard |