Enrofloxacin Base/Hydrochloride
Enrofloxacin Hydrochloride Water Soluble Powder 10%/30%/90.0%
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Item |
Standard |
Results |
Remark |
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Appearance |
Slightly yellow or pale orange yellow crystalline powder, odorless, slightly bitter; becoming orange-red on exposure to light |
Conforms |
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Solubility |
Freely soluble in chloroform and in sodium hydroxide TS, slightly soluble in methanol, very slight soluble in water, sparingly soluble in dimethylformamide |
Conforms |
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Melting range |
221-226℃ |
223.5-224.0℃ |
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Identification |
HPLC: similar in retention time to the principal peak of the reference |
Conforms |
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IR: conforms to the reference spectrum |
Conforms |
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Clarity of solution |
Clear (1g/10ml in KOH Solution) |
Conforms |
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Color of solution |
Not more intensely colored than GY4 or Y4 |
Conforms |
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Fluoroquinolonic acid |
≤0.2% |
Conforms |
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Related substance |
Ciprofloxacin≤0.5% |
0.02% |
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Related substance |
Any other single impurity≤0.3% |
0.06% |
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Total impurities≤0.7% |
0.06% |
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Loss on drying |
≤0.5% |
0.04% |
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Residue on ignition |
≤0.2% |
0.03% |
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Heavy metals |
≤20ppm |
＜20ppm |
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Conclusion |
The batch product complies with CVP2015 Standard |
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