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厄貝沙坦

基本信息
化學名稱:
2-丁基-3-[4-[2-(1H-四唑-5-基)苯基]芐基]-1,3-二氮雜螺-[4,4]壬-1-烯-4-酮;
結構式:

     

分子式:C25H28N6O
分子量:428.54
CAS號:138402-11-6
質量標準:USP/ EP/ 國家標準, GMP/ DMF 可用。

   Specification

  USP 36

     Items

  Specification

 Test results

     Appearance

  White to almost white crystalline powder

  White crystalline powder

     Identification

  IR: Should comply with reference standard

   Complies

HPLC: Should comply with reference standard

   Complies

     Water

   NMT 0.5%

   0.15%

     Sulphated ash

   NMT 0.2%

   NMT 0.2%

     Heavy meatals

   NMT 0.002%

   NMT0.002%

     Limit of Azide

   NMT 10ppm

   NMT 10ppm

     Related compounds A

   NMT 0.2%

   0.002%

 Any other individual impurity

   NMT 0.1%

   0.004%

     Total impurities

    (excluding R-isomer)

   NMT 0.5%

   0.15%

    Residual solvents

   Ethanol: NMT 5000 ppm

   28ppm

   Dichloromethane: NMT600 ppm

  Not detected

   D, D-dimethylformamide NMT880 ppm

  Not detected

   t-butyl methyl ether NMT5000 ppm

  Not detected

   Xylene: NMT1500ppm

   320ppm

   Toluene: NMT890ppm

   Not detected

     Assay (HPLC)

   98.0~102.0%

   99.9%

     Conclusion

   It Complies with USP36

 作用與用途: 抗高血壓,用于治療高血壓病
 
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