Furosemide Tablets
»Furosemide Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of furosemide (C12H11ClN2O5S).
Packaging and storage— Preserve in well-closed,light-resistant containers.
Labeling— The labeling indicates with which Dissolutiontest the product complies.Tablets intended solely for veterinary use are so labeled.
Identification— Transfer a portion of finely powdered Tablets,equivalent to about 40mg of furosemide,to a 100-mLvolumetric flask.Add 25mLof 0.1Nsodium hydroxide,and allow to stand for 30minutes with occasional shaking.Dilute with water to volume,and mix.Filter the solution,discarding the first 10mLof the filtrate,and transfer 2.0mLto a second 100-mLvolumetric flask.Add 0.02Nsodium hydroxide to volume,and mix.Proceed as directed in the Identificationtest under Furosemide Injection,beginning with “Dissolve about 10mg of USP Furosemide RS.”
Dissolution á711ñ—
Test 1: If the product complies with this test,the labeling indicates that it meets USPDissolution Test 1.
Medium: pH5.8phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 2: 50rpm.
Time: 60minutes.
Procedure— Determine the amount of C12H11ClN2O5Sdissolved from UVabsorbances at the isosbestic point at 274nm on filtered portions of the solution under test,suitably diluted with pH5.8phosphate buffer,in comparison with a Standard solution having a known concentration of USP Furosemide RSin the same Medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C12H11ClN2O5Sis dissolved in 60minutes.
Test 2: If the product complies with this test,the labeling indicates that it meets USPDissolution Test 2.Tablets labeled as intended for veterinary use comply with this test.
Apparatus 2: 65rpm.
Medium, Time,and Procedure—Proceed as directed under Test 1.
Tolerances— Not less than 80%(Q)of the labeled amount of C12H11ClN2O5Sis dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Limit of furosemide related compound B— [NOTE—Protect furosemide solutions from exposure to light.]
Mobile phase,Diluting solution,System suitability solution,andChromatographic system— Prepare as directed in the test for Related compoundsunder Furosemide.
Standard solution— Prepare a solution in Diluting solutioncontaining 8.0µg of USP Furosemide Related Compound B RSper mL.
Test solution— Transfer an accurately weighed portion of finely powdered Tablets,equivalent to about 10mg of furosemide,to a 10-mLvolumetric flask,add Diluting solutionto volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the peak responses.The response at 254nm obtained for any peak observed in the chromatogram of the Test solutionat a retention time corresponding to that of the Reference Standard in the Standard solutionis not greater than the response at 254nm 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,andChromatographic system— Prepare as directed in the test for Related compoundsunder Furosemide.
Standard preparation— Dissolve an accurately weighed quantity of USP Furosemide RSin Diluting solutionto obtain a solution having a known concentration of about 1.0mg per mL.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of furosemide,to a 50-mLvolumetric flask,add 30mLof Diluting solution,and sonicate for 10minutes.Add Diluting solutionto volume,mix,and filter,discarding the first 10mLof the filtrate.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the peak responses.Using the response at 254nm,calculate the quantity,in mg,of furosemide (C12H11ClN2O5S)in the portion of Tablets taken by the formula:
50C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Furosemide RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 878
Phone Number:1-301-816-8305