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CAS number： 97867-33-9
Molecular formula：
molecular weight：
Chemical structure：
|
Product |
Ciprofloxacin Lactate | |
|
Shelf Life |
4 years | |
|
Tests |
Acceptance Criteria | Results |
|
Description |
Almost white or pale yellow crystalline powder |
Conforms |
| Almost odorless，bitter | Conforms | |
| Hardly solube in petroleum ether, acetic ether,alcohol;very slightly solube in methnol;freely solube in water. |
|
|
| Identification tests | ||
| -1 | A solution of 8μg/ml in hydrochloric acid exhibits absorption max. at 277nm | Conforms |
| -2 | Orange red precipitate is formed. | Conforms |
| -3 | The IR spectrum conforms to that of the reference standard. | Conforms |
|
-4 |
A solution of it responds to the tests for lactate. | Conforms |
| Examine | ||
| pH） | 4.5～5.5 | 5 |
| Clarity of solution | 10 mg/ml aqueous solution is clear and colorless. | clear and colorless |
| Color of solution | The absorbance should be not more than 0.05. | 0.032 |
| Related substances | （0.5%）any single impurity≤0.5% | 0.08% |
| （1.0%）the sum of total impurities≤1.0% | 0.16% | |
| Residual solvents | 0.5% Ethanol≤0.5% | 0.008% |
| Fluorine | ≥4.3% | 4.4% |
| Loss on drying | ≤6.5% | 4.8% |
| Residue on ignition | ≤0.1% | <0.01％< td=""> |
| Heavy metals | ≤20ppm | Conforms |
| Assay (non-aqueous titration) | (C17H18FN3O3. C3H6O3, on the dried basis) ≥98.5% | 99.5% |
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