CAS number： 80214-83-1
Molecular formula： C41H76N2O15
molecular weight： 837.047
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 | |
