|
Item |
Standard |
Results |
Remark |
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|
Appearance |
Type white to pale yellow powder with hygroscopicity |
Conforms |
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|
|
Solubility |
It’s soluble in water, ethanol, trichloromethane or acetone; Insoluble in Ether |
Conforms |
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|
Identification |
Positive in phosphate test |
Positive |
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HPLC: The retention time of the test solution corresponds to that of the standard solution |
Conforms |
|
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|
pH |
5.0-7.5 |
6.2 |
|
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Water |
≤6.0% |
2.3% |
|
|
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Residue on ignition |
≤5.0% |
1.2% |
|
|
|
Heavy metal |
≤20ppm |
＜20ppm |
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Cis-isomer |
82.0-88.0% |
86.4% |
|
|
|
Trans-isomer |
12.0-18.0% |
13.6% |
|
|
|
Related substance |
Single substance on dried base ≤3.0% |
1.3% |
|
|
|
Total relevance substance on dried basis ≤9.5% |
5.4% |
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|
Tilmicosin assay |
≥75.0%(on dried basis) |
80.9% |
|
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Conclusion |
The batch product complies with House Standard |
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