Packaging and storage—
Store in single-dose or multiple-dose, light-resistant containers, of Type I glass.
Labeling—
Injection intended solely for veterinary use is so labeled.
Identification—
Transfer to a 100-mL volumetric flask a volume of Injection, equivalent to about 40 mg of furosemide, dilute with water to volume, and mix. Dilute 2.0 mL of this solution with 0.02 N sodium hydroxide in a second 100-mL volumetric flask to volume, and mix. Dissolve about 10 mg of
USP Furosemide RS in 6.0 mL of 0.1 N sodium hydroxide in a 25-mL volumetric flask, and dilute with water to volume. Dilute 2.0 mL of the resulting solution quantitatively with 0.02 N sodium hydroxide to obtain a Standard solution having a concentration of about 8 µg per mL. Concomitantly determine the UV absorption spectra of both solutions: the UV absorption spectra so obtained exhibit maxima and minima at the same wavelengths.
pH 
791
:
between 8.0 and 9.3 or, where labeled as intended solely for veterinary use, between 7.0 and 7.8 if it contains diethanolamine, or between 8.0 and 9.3 if it contains monoethanolamine.
Limit of furosemide related compound B—
[NOTE—Protect furosemide solutions from exposure to light.
]
Mobile phase, Diluting solution, System suitability solution and Chromatographic system
—Prepare as directed in the test for
Related compounds under
Furosemide.
Test solution—
Transfer an accurately measured volume of Injection, equivalent to about 10 mg of furosemide, to a 10-mL volumetric flask, add Diluting solution to volume, and mix.
Procedure—
Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. The response at 254 nm obtained for any peak observed in the chromatogram of the Test solution at a retention time corresponding to that of the Reference Standard in the Standard solution is not greater than the response at 254 nm obtained for the peak in the chromatogram of the Standard solution, corresponding to not more than 1.0% of furosemide related compound B. Where the Injection is labeled as intended solely for veterinary use, the response at 254 nm obtained in the chromatogram of the Test solution at a retention time corresponding to that of the Reference Standard in the Standard solution is not greater than 2.5 times the response at 254 nm obtained for the peak in the chromatogram of the Standard solution, corresponding to not more than 2.5% of furosemide related compound B.
Other requirements—
It meets the requirements under
Injections 1.
Assay—
[NOTE—Protect furosemide solutions from exposure to light.
]
Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—
Prepare as directed in the test for
Related compounds under
Furosemide.
Standard preparation—
Dissolve an accurately weighed quantity of
USP Furosemide RS in
Diluting solution to obtain a solution having a known concentration of about 1.0 mg per mL.
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 10 mg of furosemide, to a 10-mL volumetric flask, add Diluting solution to volume, and mix.
Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the peak responses. Using the response at 254 nm, calculate the quantity, in mg, of furosemide (C
12H
11ClN
2O
5S) in each mL of the Injection taken by the formula:
10(C / V)(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Furosemide RS in the
Standard preparation; V is the volume, in mL, of Injection taken; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
