Furosemide Tablets
» Furosemide Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of furosemide (C12H11ClN2O5S).
Packaging and storage— Preserve in well-closed, light-resistant containers.
Labeling— The labeling indicates with which Dissolution test the product complies. Tablets intended solely for veterinary use are so labeled.
USP Reference standards 11—
USP Furosemide RS Click to View Structure
USP Furosemide Related Compound A RS Click to View Structure
2-Chloro-4-N-furfurylamino-5-sulfamoylbenzoic acid.
    C12H11ClN2O5S    330.74
USP Furosemide Related Compound B RS Click to View Structure
4-Chloro-5-sulfamoylanthranilic acid.
    C7H7ClN2O4S    250.66
Identification— Transfer a portion of finely powdered Tablets, equivalent to about 40 mg of furosemide, to a 100-mL volumetric flask. Add 25 mL of 0.1 N sodium hydroxide, and allow to stand for 30 minutes with occasional shaking. Dilute with water to volume, and mix. Filter the solution, discarding the first 10 mL of the filtrate, and transfer 2.0 mL to a second 100-mL volumetric flask. Add 0.02 N sodium hydroxide to volume, and mix. Proceed as directed in the Identification test under Furosemide Injection, beginning with “Dissolve about 10 mg of USP Furosemide RS.”
Dissolution 711—
Test 1: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1.
Medium: pH 5.8 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL.
Apparatus 2: 50 rpm.
Time: 60 minutes.
Procedure— Determine the amount of C12H11ClN2O5S dissolved from UV absorbances at the isosbestic point at 274 nm on filtered portions of the solution under test, suitably diluted with pH 5.8 phosphate buffer, in comparison with a Standard solution having a known concentration of USP Furosemide RS in the same Medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C12H11ClN2O5S is dissolved in 60 minutes.
Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2. Tablets labeled as intended for veterinary use comply with this test.
Apparatus 2: 65 rpm.
Medium, Time, and Procedure—Proceed as directed under Test 1.
Tolerances— Not less than 80% (Q) of the labeled amount of C12H11ClN2O5S is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
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.
Standard solution— Prepare a solution in Diluting solution containing 8.0 µg of USP Furosemide Related Compound B RS per mL.
Test solution— Transfer an accurately weighed portion of finely powdered Tablets, 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 0.8% of furosemide related compound B.
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— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of furosemide, to a 50-mL volumetric flask, add 30 mL of Diluting solution, and sonicate for 10 minutes. Add Diluting solution to volume, mix, and filter, discarding the first 10 mL of the filtrate.
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 (C12H11ClN2O5S) in the portion of Tablets taken by the formula:
50C(rU / rS)
in which C is the concentration, in mg per mL, of USP Furosemide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison
1-301-816-8349		 (SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106		 (GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 3294