Flunixin Meglumine

(floo nix' in me' gloo meen).

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-(

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

USP Reference standards

—

USP Flunixin Meglumine RS

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

Identification—

A: Infrared Absorption

197M

B: Ultraviolet Absorption

197U

—

Solution: 1 in 30,000.

Medium: 0.1 N sodium hydroxide.

Melting range

741

: between 137

and 140

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

and

Test solution: 120 mg per mL.

Residue on ignition

281

: not more than 0.2%.

Chromatographic purity—

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.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Morgan Puderbaugh, B.S. Associate Scientific Liaison 1-301-998-6833	(SM32010) Monographs - Small Molecules 3
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 3222

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