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维达列汀
| 序号 | 项目 Item | 指标 Specification |
| 1 | 外观 Appearance | 白色或类白色结晶性粉末 White oralmost white crystalline 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 (%)(dry bass) | 99.0～101.0 |
| 4 | 水分 Water(%) | ≤0.5 |
| 5 | 灰分Sulphated ash(%) | ≤0.1 |
| 6 | 相关物质(HPLC)(%) Related substances |
impurity A ≤0.1 impurity B ≤0.1 impurity C ≤0.1 Max individual impurity ≤0.1 Total impurities ≤0.5 |
| 7 | 重金属 Heavy Metals(as Pb)(ppm) | ≤20 |
| 8 | 残留溶剂 Residual solvent(%) | 2-butanone ≤0.5 |
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