Tests 项目 | Results 结果 | Specifications 标准 |
Description 性状 | Off-white powder,very hygroscopic. 类白色粉末,极易引湿 | White to yellowish powder,very hygroscopic. 白色或淡黄色粉末,极易引湿 |
Solubility 溶解度 | Complies 符合要求 | Freetly soluble In water and methanol and dichloromethane 在水、甲醇和二氯甲烷中易溶 |
Identification 鉴别 | Complies 符合要求 | (1)By IR, To match with working standard IR图谱应与对照品一致 |
Complies 符合要求 | (2)It gives reaction of sodium 应显钠盐的鉴别反应 | |
Impurities A 杂质A | Not detected 未检出 | ≤0.1% |
Related compounds 有关物质 | <0.1% | Any impurity 任意杂质 ≤0.1% |
0.19% | Total impurities 总杂质 ≤0.4% | |
Residual Solvents 溶剂残留 | Not detected 未检出 | Acetidin乙酸乙酯≤ 0.5% |
0.04% | Dichloromethane二氯甲烷≤ 0.06% | |
0.01% | Methanol甲醇≤ 0.3% | |
0.01% | Acetone 丙酮≤ 0.5% | |
Not detected 未检出 | Acetonitrile乙腈≤0.041% | |
0.01% | Ethanol乙醇≤0.5% | |
Not detected 未检出 | N, N-dimethylformamide N,N-二甲基甲酰胺≤0.088% | |
Water 水分 | 2.35% | ≤ 5.0% |
Assay 含量 | 99.35% | 99.0%-101.0%(On anhydrous basis以干品计) |