ITEMS | SPECIFICATION | RESULT |
CHARACTERS | ||
Appearance | White to off-white powder | Complies |
IDENTIFICATIONS | ||
A | Infrared Absorption〈197k〉 | Complies |
B | HPLC | Complies |
TESTS | ||
Loss on drying | ≤5.0% | 3.6% |
Individual related compound | ≤2.5%( on dry basis) | Max. 2.1% |
Total related compounds | ≤6.5%( on dry basis) | 6.1% |
ASSAY | ||
Tilmicosin | ≥85.0% ( Tilmicosin)( on dry basis) | 93.1% |
Cis-isomer | 82.0%—88.0% | 85.8% |
Trans-isomer | 12.0%—18.0% | 14.2% |
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