3-Pyridinecarboxylic acid, 2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]-, compd. with 1-deoxy-1-(methylamino)-d-glucitol (1:1)
2-(3,3,3-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 99.0 percent and not more than 101.0 percent of C14H11F3N2O2·C7H17NO5.
Packaging and storage Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30.
Labeling Label it to indicate that it is for veterinary use only.
B: Ultraviolet Absorption 197U
Solution: 1 in 30,000.
Medium: 0.1 N sodium hydroxide.
Melting range 741: between 137 and 140.
pH 791: between 7.0 and 9.0, in a solution (1 in 20).
Loss on drying 731 Dry it at 105 for 4 hours: it loses not more than 0.5% of its weight.
Specific rotation 781S: between 9 and 12.
Test solution: 120 mg per mL.
Residue on ignition 281: not more than 0.2%.
Test solution Prepare a solution of Flunixin Meglumine in methanol containing 40 mg per mL.
Standard stock solution Prepare a solution of USP Flunixin Meglumine RS in methanol containing 40 mg per mL.
Standard solution 1 Transfer 50 µL of the Standard stock solution to a 10-mL volumetric flask, dilute with methanol to volume, and mix.
Standard solution 2 Dilute 20 µL of the Standard stock solution with 10 mL of methanol, and mix.
Procedure Separately apply 10-µL portions of the Test solution, the Stock standard solution, Standard solution 1, and Standard solution 2 to a thin-layer chromatographic plate (see Chromatography 621) 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 UV light. Compare the intensities of any secondary spots in the chromatogram obtained from the Test solution with the intensity of the principal spot in the chromatograms obtained from Standard solution 1 and from Standard solution 2: no individual secondary spot in the chromatogram obtained from the Test solution is 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 solution does not exceed the intensity of the principal spot in the chromatogram obtained from Standard solution 1 (0.5%).
Assay Dissolve about 175 mg of Flunixin Meglumine, accurately weighed, in 50 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically (see Titrimetry 541). Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 24.573 mg of C14H11F3N2O2·C7H17NO5.
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USP32NF27 Page 2396Pharmacopeial Forum: Volume No. 29(6) Page 1886