Flunixin Meglumine, chemical structure, molecular formula, Reference Standards

Flunixin Meglumine

C14H11F3N2O2·C7H17NO5 491.46

3-Pyridinecarboxylic acid,2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]-,compd.with 1-deoxy-1-(methylamino)-D-glucitol (1:1)
2-(a3,a3,a3-Trifluoro-2,3-xylidino)nicotinic acid compound with 1-deoxy-1-(methylamino)-D-glucitol (1:1) [42461-84-7].

»Flunixin Meglumine contains not less than 99.0percent and not more than 101.0percent of C14H11F3N2O2·C7H17NO5.

Packaging and storage— Preserve in well-closed containers.Store at 25

,excursions permitted between 15

and 30

USP Reference standards á11ñ— USP Flunixin Meglumine RS.

Labeling— Label it to indicate that it is for veterinary use only.

Identification—

A:Infrared Absorption á197Mñ.

B:Ultraviolet Absorption á197Uñ—

Solution: 1in 30,000.

Medium: 0.1Nsodium hydroxide.

Melting range á741ñ: between 137

and 140

pHá791ñ: between 7.0and 9.0,in a solution (1in 20).

Loss on drying á731ñ— Dry it at 105

for 4hours:it loses not more than 0.5%of its weight.

Specific rotation á781Sñ: between -9

and -12

Test solution: 120mg per mL.

Residue on ignition á281ñ: not more than 0.2%.

Chromatographic purity—

Test solution— Prepare a solution of Flunixin Meglumine in methanol containing 40mg per mL.

Standard stock solution— Prepare a solution of USP Flunixin Meglumine RSin methanol containing 40mg per mL.

Standard solution 1— Transfer 50µLof the Standard stock solutionto a 10-mLvolumetric flask,dilute with methanol to volume,and mix.

Standard solution 2— Dilute 20µLof the Standard stock solutionwith 10mLof methanol,and mix.

Procedure— Separately apply 10-µLportions of the Test solution,the Stock standard solution,Standard solution 1,and Standard solution 2to a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and in a paper-lined chamber develop the chromatogram in a solvent system consisting of a mixture of toluene,ethyl acetate,glacial acetic acid,and water (65:30:10:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and air-dry the plate.Examine the plate under short-wavelength UVlight.Compare the intensities of any secondary spots in the chromatogram obtained from the Test solutionwith the intensity of the principal spot in the chromatograms obtained from Standard solution 1and from Standard solution 2:no individual secondary spot in the chromatogram obtained from the Test solutionis more intense than the principal spot in the chromatogram obtained from Standard solution 2(0.2%),and the sum of the intensities of all the secondary spots in the chromatogram obtained from the Test solutiondoes not exceed the intensity of the principal spot in the chromatogram obtained from Standard solution 1(0.5%).

Assay— Dissolve about 175mg of Flunixin Meglumine,accurately weighed,in 50mLof glacial acetic acid.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically (see Titrimetry á541ñ).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 24.573mg of C14H11F3N2O2·C7H17NO5.

Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist

Expert Committee:(VET)Veterinary Drugs

USP28–NF23Page 837

Pharmacopeial Forum:Volume No.29(6)Page 1886

Phone Number:1-301-816-8178