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Item | Index | Result | ||||
Appearance | Almost white or yellowish crystalline powder | Yellow powder | ||||
Identification | 1) The retention time of the major peak in the chromatogram of the assay preparation corresponds to that of the standard preparation obtained as specified in the assay | Complies | ||||
2) Complies with the phosphate identification test | Complies | |||||
Related substances | Individual impurity 3.0% max | 2.22% | ||||
Total impurity 10.0% max | 5% | |||||
Water | 5.0% max | 2.8% | ||||
PH | 5.0-8.0 | 6.8 | ||||
Tilmicosin cis-isomer | 82.0-88.0% | 85.8% | ||||
Tilmicosin trans-isomer | 12.0-18.0% | 14.2% | ||||
Assay | Content of C46H80N2O13 (on dried basis) ≥75.0% | 79.2% |
Tilmicosin phosphate