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        Roxithromycin Hcl

        CAS number: 80214-83-1

        Molecular formula:

        molecular weight:

        Chemical structure:


        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