Ciprofloxacin hydrochloride is the hydrochloride of ciprofloxacin, which belongs to the second generation of synthetic quinolone antibacterial drugs. It has broad-spectrum antibacterial activity and good bactericidal effect. The antibacterial activity against almost all bacteria is better than norfloxacin. And enoxacin is 2 to 4 times stronger.
Ciprofloxacin hydrochloride has antibacterial effects on Enterobacter, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus, Legionella, and Staphylococcus aureus.
Ciprofloxacin hydrochloride is mainly used for the treatment of respiratory infections, genitourinary system infections and intestinal infections.
Tests
Acceptance Criteria
Results
Characters
Appearance
Faintly yellowish to light yellow crystalline powder.
Faintly yellowish crystalline powder
Solubility
Sparingly soluble in water; slightly soluble in acetic acid and methanol; very slightly soluble in dehydrated alcohol; practically insoluble in acetone, in acetonitrile, in ethyl acetate, in hexane, and in methylene chloride.
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Identification
IR: Conforms to the spectrum of Ciprofloxacin Hydrochloride RS.
Conforms
HPLC: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution , as obtained in the Assay .
Responds to the tests for chloride.
pH
3.0〜4.5 (1g/40ml water)
3.8
Water
4.7 -6.7%
6.10%
Residue on ignition
≤ 0.1%
0.02%
Heavy metals
≤ 0.002%
< 0.002%
Chromatographic purity
Ciprofloxacin ethylenediamine analog
≤0.2%
0.07%
fluoroquinolonic acid
≤0.2%
0.08%
Any other individual impurity
≤0.2%
0.04%
The sum of all impurities
≤0.5%
0.07%
Assay
98.0%〜102.0% of C17H18FN3O3 • HCL (On the anhydrous substance)
99.60%
Residual solvents
Ethanol
≤5000ppm
315ppm
Toluene
≤890ppm
Not detected
Isoamyl alcohol
≤2500ppm
Not detected
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