TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White or off-white powder | Conforms |
Identification | IR spectra is consistent with CRS | Conforms |
The retention time of the major peak of the assay preparation corresponds to that of the standard preparation, as obtained in the assay | Conforms | |
Water | ≤5.0% | 2.1% |
Cis-Isomer | 82.0%~88.0% | 86.0% |
Trans-Isomer | 12.0%~18.0% | 14.0% |
Individual impurity | ≤3.0% | 1.6% |
Total impurities | ≤10.0% | 6.2% |
Residue on ignition | ≤5.0% | 1.8% |
Heavy metal | ≤30ppm | <30ppm |
Assay(Tilmicosin) | ≥85.0% | 93.8% |
Conclusion: The Product Conforms to USP. |