Test Items | Specification: | Results |
Appearance | Light yellow powder | Light yellow powder |
Identification | IR spectra is consistent with CRS. The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation,as obtained in the assay. | Conforms |
pH | 5.0~8.0 | 6.8 |
Water | ≤5.0% | 3.5% |
Cis-isomer | 82.0%~88.0% | 84.5% |
Tran-isomer | 12.0%~18.0% | 15.5% |
Assay (on dried basis) | ≥75.0% (tilmicosin) | 98% |