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Ciprofloxacin Hcl
Ciprofloxacin Hcl
CAS No.:85721-33-1
Molecular Formula:C17H18FN3O3
Molecular Weight:331.34
PRODUCT NAME:Ciprofloxacin Hcl

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

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.

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.

 

Conforms

pH

3.04.5 (lg/z40ml water)

3.8

Water

4.7 -6.7%

6.1%

Residue on ignition

W 0.1%

0.01%

Heavy metals

W 0.002%

< 0.002%

HPLC

Chromatographic purity

1)

Ciprofloxacin ethylenediamine analog

W0.2%

0.07%

2)fluoroquinolonic acid

W0.2%

0.09%

2)Any other individual impurity

W0.2%

0.05%

3)The sum of all impurities

W0.5%

0.12%

(HPLC)Assay

98.0%102.0% of C17H]gFN3O3 HCL (On the anhydrous substance)

99 6%

Residual solvents

 

(1) Ethanol

W5000ppm

315ppm

(2)Toluene

W890ppm

Not detected

(3) I so amyl alcohol

W2500ppm

Not detected

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