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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 (HPLC) (%)
Related substances
Single impurity ≤0.3
Total impurities ≤ 1.0
7 重金屬 Heavy Metals(as Pb) (ppm) ≤20
 
 
 
 
 
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