{"id":23994,"date":"2025-11-01T15:51:23","date_gmt":"2025-11-01T08:51:23","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=23994"},"modified":"2025-11-01T17:36:33","modified_gmt":"2025-11-01T10:36:33","slug":"flunixin-meglumine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/flunixin-meglumine\/","title":{"rendered":"Flunixin Meglumine"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

Action and use<\/strong><\/p>\n

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n

Ph Eur<\/p>\n

\n

DEFINITION<\/h2>\n

2-[[2-Methyl-3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid, 1-deoxy-1-(methylamino)-D-glucitol.<\/p>\n

Content<\/strong><\/p>\n

99.0 per cent to 101.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water and in methanol, practically insoluble in acetone.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Specific optical rotation (2.2.7): -12.0 to -9.0 (dried substance), determined on solution S (see Tests).<\/p>\n

B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison\u00a0 flunixin meglumine CRS.<\/em><\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 2.50 g in carbon dioxide-free water R and dilute to 50.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y7 (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/strong><\/p>\n

7.0 to 9.0 for solution S.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Test solution<\/em> Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (a)<\/em> Dissolve 5.0 mg of flunixin impurity B CRS in 1.0 mL of the test solution and dilute to 50.0 mL with the mobile phase.<\/p>\n

Reference solution (b)<\/em> Dissolve 5.0 mg of 2-chloronicotinic acid R (impurity A) in the mobile phase and dilute to 50.0 mL with the mobile phase. To 2.0 mL of this solution add 2.0 mL of reference solution (a) and dilute to 20.0 mL with the mobile phase.<\/p>\n

Reference solution (c)<\/em> Dissolve 50 mg of flunixin impurity C CRS in the mobile phase and dilute to 100 mL with the mobile phase.<\/p>\n

Column:<\/em><\/p>\n

\u2014 size: l<\/em> = 0.125 m, \u00d8 = 4.0 mm,<\/p>\n

\u2014 stationary phase:<\/em> octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n

Mobile phase<\/em> Mix 300 volumes of water R and 700 volumes of acetonitrile R, and add 0.25 volumes of phosphoric acid R.<\/p>\n

Flow rate<\/em>\u00a0 1.0 mL\/min.<\/p>\n

Detection<\/em>\u00a0 Spectrophotometer at 254 nm.<\/p>\n

Injection\u00a0<\/em> 10 \u00b5L.<\/p>\n

Run time<\/em>\u00a0 5 times the retention time of flunixin.<\/p>\n

Relative retention<\/em> With reference to flunixin (retention time = about 3.1 min): impurity A = about 0.4; impurity C = about 0.6; impurity B = about 0.7; impurity D = about 4.2.<\/p>\n

System suitability<\/em>\u00a0 Reference solution (a):<\/p>\n

\u2014 resolution:<\/em> minimum 3.5 between the peaks due to impurity B and flunixin.<\/p>\n

Limits:<\/em><\/p>\n

\u2014 correction factor:<\/em> for the calculation of content, multiply the peak area of impurity C by 1.9,<\/p>\n

\u2014 impurity A:<\/em> not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.2 per cent),<\/p>\n

\u2014 impurity B:<\/em> not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.2 per cent),<\/p>\n

\u2014 impurities C, D:<\/em> for each impurity, not more than the area of the peak due to flunixin in the chromatogram obtained with reference solution (b) (0.2 per cent),<\/p>\n

\u2014 any other impurity:<\/em> for each impurity, not more than the area of the peak due to flunixin in the chromatogram obtained with reference solution (b) (0.2 per cent),<\/p>\n

\u2014 total:<\/em> not more than 2.5 times the area of the peak due to flunixin in the chromatogram obtained with reference solution (b) (0.5 per cent),<\/p>\n

\u2014 disregard limit:<\/em> 0.25 times the area of the peak due to flunixin in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n

Loss on drying (2.2.32)<\/strong><\/p>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 4 h.<\/p>\n

Sulfated ash (2.4.14)<\/strong><\/p>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.175 g in 50 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M perchloric acid is equivalent to 24.57 mg of C21<\/sub>H28<\/sub>F3<\/sub>N3<\/sub>O7<\/sub>.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities\u00a0 A, B, C, D.<\/p>\n

\"Flunixin<\/p>\n

A. 2-chloropyridine-3-carboxylic acid,<\/p>\n

\"Flunixin<\/p>\n

B. 2-methyl-3-(trifluoromethyl)aniline,<\/p>\n

\"Flunixin<\/p>\n

C. ethyl 2-chloropyridine-3-carboxylate,<\/p>\n

\"Flunixin<\/p>\n

D. ethyl 2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylate.<\/p>\n

\n

Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. Ph Eur DEFINITION 2-[[2-Methyl-3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid, 1-deoxy-1-(methylamino)-D-glucitol. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water and in methanol, practically insoluble in acetone. IDENTIFICATION A. Specific optical rotation…<\/p>\n","protected":false},"author":5,"featured_media":23995,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-23994","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=23994"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23994\/revisions"}],"predecessor-version":[{"id":24253,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23994\/revisions\/24253"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23995"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}