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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