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序号 | 项目Item | 指标Specification |
1 | 外观Appearance | 白色结晶性粉末 Whitecrystalline powder |
2 | 鉴别 Identification |
IR: corresponds to the standard UV: corresponds to the standard |
3 | 比旋度 (º) Specific optical rotation (º) |
1.0% methanol (20ºC),+96~+100 |
3 | 含量 Assay (%) | ≥98.0 |
4 | 水分 Water(%) | ≤0.3 |
5 | 灰分Sulphated ash (%) | ≤0.1 |
6 | 相关物质 (HPLC) (%) Related substances |
Single impurity ≤0.3 Total impurities ≤ 1.0 |
7 | 重金属 Heavy Metals(as Pb) (ppm) | ≤20 |