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 (1 to 2 mg per 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.
Color 
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.
Identification—
Dilute a quantity of Injection with water to obtain a test solution having a concentration of about 0.5 mg of ciprofloxacin per mL. Dissolve a quantity of
USP Ciprofloxacin Hydrochloride RS in water to obtain a Standard solution containing the equivalent of 0.5 mg of ciprofloxacin per mL. Separately apply, as 1-cm bands, 10 µL each of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see
Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Proceed as directed for
Identification test
B under
Ciprofloxacin Hydrochloride, beginning with “Place the plate.” The specified results are obtained.
Delete the following:
Pyrogen—
It meets the requirements of the
Pyrogen Test 151, the test dose being 20 mg of ciprofloxacin per kg.
USP29
Sterility 71—
It meets the requirements when tested as directed for
Membrane Filtration under
Test for Sterility of Product to be Examined.
pH 791:
between 3.5 and 4.6, except that where the Injection is labeled as being a concentrated form, its pH is between 3.3 and 3.9.
Limit of ciprofloxacin ethylenediamine analog—
Mobile phase and Chromatographic system—
Proceed as directed in the
Assay under
Ciprofloxacin.
Standard preparation, Resolution solution, and Assay preparation—
Proceed as directed in the
Assay under
Ciprofloxacin.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Ciprofloxacin. Calculate the percentage of ciprofloxacin ethylenediamine analog from the chromatogram obtained from the
Assay preparation in the
Assay under
Ciprofloxacin by the formula:
100[0.7rA / (0.7rA + rC)]
in which 0.7 is the correction factor for ciprofloxacin ethylenediamine analog; and
rA and
rC are the responses of the ciprofloxacin ethylenediamine analog peak and the ciprofloxacin peak, respectively. It contains not more than 0.5% of ciprofloxacin ethylenediamine analog.
Lactic acid content—
Mobile phase—
Prepare a mixture of 0.005 N sulfuric acid and acetonitrile (850:150), and degas. Make adjustments if necessary (see
System Suitability under
Chromatography 621).
Standard preparation—
Quantitatively dissolve an accurately weighed quantity of
USP Sodium Lactate RS in water to obtain a solution having a known concentration of about 0.8 mg per mL, or of about 4 mg per mL where the Injection is labeled as being a concentrated form.
Test preparation—
Use the undiluted Injection.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 208-nm detector and a 7.8-mm × 30-cm column that contains packing L17 and is operated at 40 ± 1
. The flow rate is about 0.6 mL per minute. Chromatograph the
Standard preparation, and record the peak responses as directed for
Procedure: the tailing factor for the analyte peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
[NOTE—After 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.
]
Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Test preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of lactic acid (C
3H
6O
3) in each mL of the Injection taken by the formula:
(90.08/112.07)(C)(rU / rS)
in which 90.08 and 112.07 are the molecular weights of lactic acid and sodium lactate, respectively;
C is the concentration, in mg per mL, of
USP Sodium Lactate RS in the
Standard preparation; and
rU and
rS are the responses of the lactic acid peaks obtained from the
Test preparation and the
Standard preparation, respectively. It contains between 0.288 mg and 0.352 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 between 0.335 and 0.409 mg of lactic acid for each mg of ciprofloxacin claimed on the label.
Dextrose content (if present)—
Using the undiluted Injection, determine the angular rotation in a suitable polarimeter tube (see
Optical Rotation 781). Calculate the percentage (g per 100 mL) of C
6H
12O
6·H
2O in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)AR,
in which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively;
A is 100 mm divided by the length of the polarimeter tube, in mm; and
R is the observed rotation, in degrees: between 4.75 and 5.25 g of C
6H
12O
6·H
2O is found.
Sodium chloride content (if present)—
Transfer 10.0 mL of Injection to a suitable container, dilute with water to about 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 NaCl: between 85.5 mg and 94.5 mg of NaCl is found.
Assay—
Mobile phase and Chromatographic system—
Proceed as directed in the
Assay under
Ciprofloxacin.
Standard preparation—
Quantitatively dissolve an accurately weighed quantity of
USP Ciprofloxacin Hydrochloride RS in
Mobile phase to obtain a solution having a known concentration of about 0.3 mg per mL.
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 25 mg of ciprofloxacin, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure—
Separately inject equal volumes (about 10 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the area responses for the major peaks. Calculate the quantity, in mg, of ciprofloxacin in each mL of the Injection taken by the formula:
(331.34/367.81)(100C/V)(rU / rS)
in which 331.34 and 367.81 are the molecular weights of ciprofloxacin and anhydrous ciprofloxacin hydrochloride, respectively;
C is the concentration, in mg per mL, of
USP Ciprofloxacin Hydrochloride RS in the
Standard preparation, calculated on the anhydrous basis;
V is the volume, in mL, of Injection taken to prepare the
Assay preparation; and
rU and
rS are the ciprofloxacin peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
