|
Item |
Standard |
Results |
Remark |
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|
Appearance |
White to pale yellow powder |
Pale yellow powder |
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|
Solubility |
Freely soluble in Chloroform; Soluble in Water or Methanol; Insoluble in Ether |
Conforms |
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Identification |
Positive |
Positive |
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Chromatogram |
Conforms |
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|
pH |
5.0-7.5 |
6.2 |
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|
Loss on drying |
≤5.0% |
2.6% |
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Residue on ignition |
≤5.0% |
0.85% |
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|
Heavy metal |
≤20ppm |
＜20ppm |
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Tyramine |
|
Conforms |
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Potency |
≥800u/mg |
862/mg(Wet) |
|
|
|
885u/mg(Dry) |
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|
Tylosin compositions |
Tylosin A ≥80.0% |
88.4% |
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A+B+C+D ≥95.0% |
97.42% |
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Conclusion |
The batch product complies with CVP2015 Standard |
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