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      Roxithromycin Hcl

      CAS number: 80214-83-1

      Molecular formula:

      molecular weight:

      Chemical structure:

      Details

      Name of product Roxithromycin hcl
      EXP. Time 3 years
      Analysis content Analysis results Standard
      Appearance White or almost white crystalline powder white crystalline powder
      Identification 1) IR:  conforms to the Roxithromycin CRS specturm Meets the requirements
      2) HPLC: Similar inreatention time and size to the principal peak of the reference solution conforms
      Appearance of solution clear and colourless conforms
      Specific Rotation between -93o-96o  -95o
      Assay(HPLC) 99.69% 99.0~100%
      Related substances 1) Impurity G% less than 1.0% 0.09%

      2) Impurity A,B,C,D,E,F,H,I,J less than 0.5% 0.31%
      3)Total Impurities less than 3.0% 1.7%
      Heavy metals less than 10ppm <10ppm
      water less than 3.0% 2.2%
      Sulphated ash less than 0.1% 0.02%
      Residual solvents methanol less than 3000PPM 286PPM
      acetone less than 5000ppm not detected
      methylene chloride less than 600ppm not detected
      Conclusion:  Complies with requirements of EP8.0