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卡培他賓
序號 | 項目Item | 指標Specification |
1 | 外觀Appearance | 白色結晶性粉末 Whitecrystalline 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 (%) | ≥98.0 |
4 | 水分 Water(%) | ≤0.3 |
5 | 灰分Sulphated ash (%) | ≤0.1 |
6 | 相關物質(zhì) (HPLC) (%) Related substances |
Single impurity ≤0.3 Total impurities ≤ 1.0 |
7 | 重金屬 Heavy Metals(as Pb) (ppm) | ≤20 |