Ciprofloxacin Injection is a sterile solution of Ciprofloxacin or Ciprofloxacin Hydrochloride in Water for Injection, in 5% Dextrose Injection, or in 0.9% Sodium Chloride Injection prepared with the aid of Lactic Acid. It contains NLT 90.0% and NMT 110.0% of the labeled amount of ciprofloxacin (C17H18FN3O3).
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Solution A: 0.025 M phosphoric acid. Adjust with triethylamine to a pH of 3.0 ± 0.1.
Mobile phase: Acetonitrile and Solution A (13:87)
Standard solution: 0.5 mg/mL of USP Ciprofloxacin Hydrochloride RS in Mobile phase
System suitability solution: 0.025 mg/mL of USP Ciprofloxacin Ethylenediamine Analog RS in Mobile phase. Transfer 1.0 mL of this solution to a 10-mL volumetric flask, and dilute with Standard solution to volume.
Sample solution: Equivalent to 0.5 mg/mL of Ciprofloxacin from Injection diluted with Mobile phase
Detector: UV 278 nm
Column: 4.6-mm × 25-cm; packing L1
Temperature: 30 ± 1
Flow rate: 1.5 mL/min
Injection size: 10 µL
Samples: Standard solution and System suitability solution
[NoteThe relative retention times for ciprofloxacin ethylenediamine analog and ciprofloxacin are 0.7 and 1.0, respectively. ]
Resolution: NLT 6 between the ciprofloxacin ethylenediamine analog peak and the ciprofloxacin peak
Column efficiency: NLT 2500 theoretical plates from the ciprofloxacin peak, Standard solution
Tailing factor: NMT 2.5 for the ciprofloxacin peak, Standard solution
Relative standard deviation: NMT 1.5%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of C17H18FN3O3 from the portion of Ciprofloxacin Injection taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria: 90.0%110.0%
• Lactic Acid Content
Mobile phase: Acetonitrile and 0.005 N sulfuric acid (3:17)
Standard solution: 0.8 mg/mL of USP Sodium Lactate RS in water or 4 mg/mL where the Injection is labeled as being a concentrated form
Sample solution: Use the undiluted Injection.
Detector: UV 208 nm
Column: 7.8-mm × 30-cm; packing L17
Temperature: 40 ± 1
Flow rate: 0.6 mL/min
Injection size: 20 µL
Sample: Standard solution
Tailing factor: NMT 2.0 for the analyte peak
Relative standard deviation: NMT 2.0%
[NoteAfter each analysis, rinse the column with a mixture of 0.01 N sulfuric acid and acetonitrile to elute the ciprofloxacin from the column. Promptly regenerate the column with 0.01 N sulfuric acid, and the column may be reused or stored. ]
Samples: Standard solution and Sample solution
Calculate the concentration of lactic acid (C3H6O3) in mg/mg of ciprofloxacin:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2)
Acceptance criteria: 0.2880.352 mg of lactic acid for each mg of ciprofloxacin claimed on the label, except that where the Injection is labeled as being a concentrated form, it contains 0.3350.409 mg of lactic acid for each mg of ciprofloxacin claimed on the label
• Dextrose Content (if present)
Sample solution: Undiluted Injection
Analysis: Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 781).
Calculate the percentage (g/100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken:
Result = A × R × (Mr1/Mr2) × (100/F)
Acceptance criteria: 4.755.25 g/100 mL
• Sodium Chloride Content (if present)
Sample solution: Injection
Analysis: Transfer 10.0 mL of Sample solution to a suitable container, dilute with water to 150 mL, add 1.5 mL of potassium chromate TS, and titrate with 0.1 N silver nitrate TS. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride (NaCl).
Acceptance criteria: 85.594.5 mg
• Procedure: Limit of Ciprofloxacin Ethylenediamine Analog
Mobile phase, System suitability solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.
Sample: Sample solution
Calculate the percentage of ciprofloxacin ethylenediamine analog from the portion of Ciprofloxacin Injection taken:
Result = [F × rA/(F × rA + rC)] × 100
Acceptance criteria: NMT 0.5%
• Particulate Matter in Injections 788: Meets the requirements
• pH 791: 3.54.6, except that where the Injection is labeled as being a concentrated form, its pH is 3.33.9
• Bacterial Endotoxins Test 85: It contains NMT 0.50 USP Endotoxin Unit/mg of ciprofloxacin.
• Sterility Tests 71: It meets the requirements for Test for Sterility of the Product to Be Examined, Membrane Filtration.
• Color and Achromicity 631 (where it is labeled as being a concentrated form): It has no more color than a solution prepared by diluting 5.0 mL of Matching Fluid O with 95.0 mL of 0.12 N hydrochloric acid.
• Other Requirements: It meets the requirements for Injections 1, Volume in Container.
• Packaging and Storage: Preserve in single-dose containers, preferably of Type I glass, and store in a cool place or at controlled room temperature. Avoid freezing and exposure to light.
• Labeling: The label indicates whether the vehicle is Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection. Label the Injection that has Sterile Water for Injection as the vehicle to indicate that it is a concentrated form that must be diluted to appropriate strength (12 mg/mL) with 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration, and that the resulting solution is stable for up to 14 days when stored in a cool place or at controlled room temperature.
• USP Reference Standards 11
USP Ciprofloxacin Ethylenediamine Analog RS
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
USP Endotoxin RS
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USP35NF30 Page 2673Pharmacopeial Forum: Volume No. 35(4) Page 840