Ciprofloxacin Hydrochloride(93107-08-5)
Product Description
● 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. | / | ||
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 |