Furosemide Injection
»Furosemide Injection is a sterile solution of Furosemide in Water for Injection prepared with the aid of Sodium Hydroxide or,where intended solely for veterinary use,Diethanolamine or Monoethanolamine.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of furosemide (C12H11ClN2O5S).
Packaging and storage— Store in single-dose or multiple-dose,light-resistant containers,of Type Iglass.
Labeling— Injection intended solely for veterinary use is so labeled.
Identification— Transfer to a 100-mLvolumetric flask a volume of Injection,equivalent to about 40mg of furosemide,dilute with water to volume,and mix.Dilute 2.0mLof this solution with 0.02Nsodium hydroxide in a second 100-mLvolumetric flask to volume,and mix.Dissolve about 10mg of USP Furosemide RSin 6.0mLof 0.1Nsodium hydroxide in a 25-mLvolumetric flask,and dilute with water to volume.Dilute 2.0mLof the resulting solution quantitatively with 0.02Nsodium hydroxide to obtain a Standard solution having a concentration of about 8µg per mL.Concomitantly determine the UVabsorption spectra of both solutions:the UVabsorption spectra so obtained exhibit maxima and minima at the same wavelengths.
Bacterial endotoxins á85ñ— It contains not more than 3.6USP Endotoxin Units per mg of furosemide.
pHá791ñ: between 8.0and 9.3or,where labeled as intended solely for veterinary use,between 7.0and 7.8if it contains diethanolamine,or between 8.0and 9.3if it contains monoethanolamine.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Limit of furosemide related compound B— [NOTE—Protect furosemide solutions from exposure to light.]
Mobile phase,Diluting solution,System suitability solutionandChromatographic system —Prepare as directed in the test for Related compoundsunder Furosemide.
Standard solution— Prepare a solution in Diluting solutioncontaining 10.0µg of USP Furosemide Related Compound B RSper mL.
Test solution— Transfer an accurately measured volume of Injection,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 1.0%of furosemide related compound B.Where the Injection is labeled as intended solely for veterinary use,the response at 254nm obtained in the chromatogram of the Test solutionat a retention time corresponding to that of the Reference Standard in the Standard solutionis not greater than 2.5times the response at 254nm 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 á1ñ.
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— Transfer an accurately measured volume of Injection,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 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 each mLof the Injection taken by the formula:
10(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Furosemide RSin the Standard preparation;Vis the volume,in mL,of Injection taken;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 876
Phone Number:1-301-816-8305