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          維達列汀

          序號 項目 Item 指標 Specification
          1 外觀 Appearance 白色或類白色結晶性粉末
          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 相關物質(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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