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Arshine Group Co.,Ltd.
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Ciprofloxacin is an antibiotic used to treat a number of bacterial infections. This includes bone and joint infections, intra abdominal infections, certain type of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others. For some infections it is used in addition to other antibiotics. It can be taken by mouth, in eye drops, or intravenously.
1. Cipofloxacin HCl drug is used for the treatment of Bacterial infection of Respiratory tract, UTI, Uncomplicated Cystitis in females, GI, Chronic Bacterial Prostatitis, CNS, Immuno compromised patients, Skin, Bone and Joint Infections, Uncomplicated cervical and urethral gonorrhea.
2. Ciprofloxacin HCl drug has in vitro activity against a wide range of gram-negative and gram-positive organisms.
3.Ciprofloxacin HCl drug inhibits bacterial DNA gyrase, an enzyme responsible for counteracting excessive supercoiling of DNA during replication or transcription. The mechanism of action of quinolones, including Ciprofloxacin HCl drug, is different from that of other antimicrobial agents such as betalactams, macrolides, tetracyclines, or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to Ciprofloxacin HCl drug. There is no known crossresistance between ciprofloxacin HCl drug and other classes of antimicrobials
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Tests
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Acceptance Criteria
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Results
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Characters
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Appearance
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Faintly yellowish to light yellow crystalline powder.
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Faintly yellowish
crystalline powder
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Solubility
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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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/
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Identification
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IR: Conforms to the spectrum of Ciprofloxacin Hydrochloride RS.
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.
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Conforms
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pH
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3.0〜4.5 (lg/z40ml water)
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3.8
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Water
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4.7 -6.7%
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6.1%
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Residue on ignition
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W 0.1%
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0.01%
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Heavy metals
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W 0.002%
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< 0.002%
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HPLC
Chromatographic purity
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1)
Ciprofloxacin ethylenediamine analog
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W0.2%
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0.07%
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2)fluoroquinolonic acid
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W0.2%
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0.09%
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2)Any other individual impurity
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W0.2%
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0.05%
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3)The sum of all impurities
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W0.5%
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0.12%
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(HPLC)Assay
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98.0%〜102.0% of C17H]gFN3O3 • HCL (On the anhydrous substance)
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99 6%
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Residual solvents
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(1) Ethanol
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W5000ppm
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315ppm
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(2)Toluene
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W890ppm
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Not detected
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(3) I so amyl alcohol
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W2500ppm
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Not detected
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