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維達(dá)列汀
| 序號(hào) | 項(xiàng)目 Item | 指標(biāo) Specification |
| 1 | 外觀(guān) Appearance | 白色或類(lèi)白色結(jié)晶性粉末 White oralmost white crystalline powder |
| 2 | 鑒別 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 | 相關(guān)物質(zhì)(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 | 重金屬 Heavy Metals(as Pb)(ppm) | ≤20 |
| 8 | 殘留溶劑 Residual solvent(%) | 2-butanone ≤0.5 |
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