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Ciprofloxacin Lactate

CAS number: 97867-33-9

Molecular formula:

molecular weight:

Chemical structure:

Details

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%