Flunixin Meglumine

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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-(α³,α³,α³-Trifluoro-2,3-xylidino)nicotinic acid compound with 1-deoxy-1-(methylamino)-D-glucitol (1:1)

1-Deoxy-1-(methylamino)-D-glucitol 2-{[2-methyl-3-(trifluoromethyl)phenyl]amino}nicotinate CAS RN^®: 42461-84-7; UNII: 8Y3JK0JW3U.

1 DEFINITION

Flunixin Meglumine contains NLT 98.0% and NMT 102.0% of flunixin meglumine (C₁₄H₁₁F₃N₂O₂·C₇H₁₇NO₅).

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197M (CN 1-MAY-2020)

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 PROCEDURE

Mobile phase: Acetonitrile and water (70:30). Add 0.25 mL of phosphoric acid for each L prepared.

System suitability solution: 0.1 mg/mL each of USP Flunixin Meglumine RS and USP Flunixin Related Compound B RS in Mobile phase

Standard solution: 0.3 mg/mL of USP Flunixin Meglumine RS in Mobile phase

Sample solution: 0.3 mg/mL of Flunixin Meglumine in Mobile phase

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm x 15-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

3.3 System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 3.0 between flunixin related compound B and flunixin meglumine, System suitability solution

Relative standard deviation: NMT 0.73, Standard solution

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of flunixin meglumine (C₁₄H₁₁F₃N₂O₂·C₇H₁₇NO₅) in the portion of Flunixin Meglumine taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Flunixin Meglumine RS in the Standard solution (mg/mL)

C_U = concentration of Flunixin Meglumine in the Sample solution (mg/mL)

Acceptance criteria: 98.0%-102.0%

4 IMPURITIES

4.1 RESIDUE ON IGNITION (281)

NMT 0.2%

4.2 ORGANIC IMPURITIES

Mobile phase, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.01 mg/mL each of USP Flunixin Meglumine RS, USP Flunixin Related Compound A RS, USP Flunixin Related Compound

B RS, and USP Flunixin Related Compound C RS in Mobile phase

Sample solution: 5.0 mg/mL of Flunixin Meglumine in Mobile phase

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 3.0 between flunixin related compound B and flunixin meglumine, System suitability solution

Relative standard deviation: NMT 1.0, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of flunixin related compounds A, B, and C in the portion of Flunixin Meglumine taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response of each individual impurity from the Sample solution

r_S = peak response of the corresponding related compound from the Standard solution

C_S = concentration of the corresponding related compound in the Standard solution (mg/mL)

C_U = concentration of Flunixin Meglumine in the Sample solution (mg/mL)

Calculate the percentage of flunixin ethyl ester and any other individual impurity in the portion of Flunixin Meglumine taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response of each individual impurity from the Sample solution

r_S = peak response of flunixin from the Standard solution

C_S = concentration of USP Flunixin Meglumine RS in the Standard solution (mg/mL)

C_U = concentration of Flunixin Meglumine in the Sample solution (mg/mL)

Acceptance criteria: See Table 1. The reporting level for impurities is 0.05%.

Table 1

^a Chloronicotinic acid; 2-Chloronicotinic acid.

^b Ethyl chloronicotinate; Ethyl 2-chloronicotinate.

^c Trifluoromethyl toluidine; 2-Methyl-3-(trifluoromethyl)aniline.

^d Ethyl 2-{[2-methyl-3-(trifluoromethyl)phenyl]amino}nicotinate.

5 SPECIFIC TESTS

5.1 PH (791)

Sample solution: 50 mg/mL in water

Acceptance criteria: 7.0-9.0

5.2 LOSS ON DRYING (731)

Analysis: Dry at 105° for 4 h.

Acceptance criteria: NMT 0.5%

5.3 OPTICAL ROTATION, Specific Rotation(781S).

Sample solution: 120 mg/mL in water

Acceptance criteria: -9° to -12°

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE

Preserve in well-closed containers. Store at 25°, excursions permitted between 15° and 30°.

6.2 LABELING

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

6.3 USP REFERENCE STANDARDS (11)

USP Flunixin Meglumine RS

USP Flunixin Related Compound A RS

Chloronicotinic acid;

2-Chloronicotinic acid.

C₆H₁₄CINO₂ 157.55

USP Flunixin Related Compound B RS

Trifluoromethyl toluidine;

2-Methyl-3-(trifluoromethyl)aniline.

C₈H₈F₃N 175.15

USP Flunixin Related Compound C RS

Ethyl chloronicotinate;

Ethyl 2-chloronicotinate.

C₈H₈CINO₂ 185.61