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