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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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