{"id":31700,"date":"2025-11-14T08:45:16","date_gmt":"2025-11-14T01:45:16","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=31700"},"modified":"2025-11-14T08:49:33","modified_gmt":"2025-11-14T01:49:33","slug":"tranexamic-acid","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/tranexamic-acid\/","title":{"rendered":"Tranexamic Acid"},"content":{"rendered":"

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

(Ph. Eur. monograph 0875)<\/p>\n

\"Tranexamic<\/p>\n

C8<\/sub>H15<\/sub>NO2<\/sub> 157.2 1197-18-8<\/p>\n

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

Antifibrinolytic.<\/p>\n

Preparations<\/strong><\/p>\n

Tranexamic Acid Injection<\/p>\n

Tranexamic Acid Mouthwash<\/p>\n

Tranexamic Acid Oral Solution<\/p>\n

Tranexamic Acid Tablets<\/p>\n

Ph Eur<\/p>\n

DEFINITION<\/h2>\n

(1r,4r)-4-(Aminomethyl)cyclohexane-1-carboxylic acid.<\/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 glacial acetic acid, practically insoluble in acetone and in ethanol (96 per cent).<\/p>\n

IDENTIFICATION<\/h2>\n

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

Comparison tranexamic acid CRS.<\/p>\n

TESTS<\/h2>\n

pH (2.2.3)<\/h3>\n

7.0 to 8.0.<\/p>\n

Dissolve 2.5 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent.<\/p>\n

Related substances<\/h3>\n

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

Test solution\u00a0 \u00a0Dissolve 0.200 g of the substance to be examined in water R and dilute to 20.0 mL with the same solvent.<\/p>\n

Reference solution (a)\u00a0 \u00a0Dilute 1.0 mL of the test solution to 100.0 mL with water R. Dilute 1.0 mL of this solution to 20.0 mL with water R.<\/p>\n

Reference solution (b)\u00a0 \u00a0Dissolve 5.0 mg of tranexamic acid impurity D CRS in water R and dilute to 50.0 mL with the same solvent.<\/p>\n

Reference solution (c)\u00a0 \u00a0Dilute 5.0 mL of reference solution (b) to 100.0 mL with water R.<\/p>\n

Reference solution (d)\u00a0 \u00a0Dissolve 2.5 mg of tranexamic acid impurity E CRS in water R and dilute to 50.0 mL with the same solvent. Dilute 1.0 mL of the solution to 10.0 mL with water R.<\/p>\n

Reference solution (e)\u00a0 \u00a0Dissolve 2.5 mg of tranexamic acid impurity C CRS, 2.5 mg of tranexamic acid impurity F CRS and 7.5 mg of tranexamic acid impurity B CRS in 25 mL of water R. Mix 1 mL of the solution, 1 mL of reference solution (b) and 18 mL of the test solution.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n

Mobile phase\u00a0 \u00a0Dissolve 11.0 g of anhydrous sodium dihydrogen phosphate R in 500 mL of water for chromatography R and add 5 mL of triethylamine R and 1.4 g of sodium laurilsulfate R1; adjust to pH 2.0 with phosphoric acid R and dilute to 600 mL with water for chromatography R; add 400 mL of methanol R2.<\/p>\n

Flow rate\u00a0 \u00a00.9 mL\/min.<\/p>\n

Detection\u00a0 \u00a0Spectrophotometer at 210 nm.<\/p>\n

Injection\u00a0 \u00a040 \u03bcL of the test solution and reference solutions (a), (c), (d) and (e).<\/p>\n

Run time\u00a0 \u00a02.5 times the retention time of tranexamic acid.<\/p>\n

Identification of impurities\u00a0 \u00a0Use the chromatogram obtained with reference solution (c) to identify the peak due to impurity D; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity E; use the chromatogram obtained with reference solution (e) to identify the peaks due to impurities B, C and F.<\/p>\n

Relative retention\u00a0 \u00a0With reference to tranexamic acid (retention time = about 10 min): impurity F = about 0.3; impurity C = about 1.1; impurity D = about 1.2; impurity E = about 1.3; impurity B = about 1.5.<\/p>\n

System suitability\u00a0 \u00a0Reference solution (e):<\/p>\n

\u2014 resolution: minimum 2.0 between the peaks due to tranexamic acid and impurity C; minimum 1.5 between the
\npeaks due to impurities C and D.<\/p>\n

Calculation of percentage contents:<\/p>\n

\u2014 correction factors: multiply the peak areas of the following impurities by the corresponding correction factor: impurity B = 1.3; impurity C = 0.4; impurity F = 0.6;<\/p>\n

\u2014 for impurities C and D, use the concentration of impurity D in reference solution (c);<\/p>\n

\u2014 for impurities E and F, use the concentration of impurity E in reference solution (d);<\/p>\n

\u2014 for impurities other than C, D, E and F, use the concentration of tranexamic acid in reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 impurity B: maximum 0.15 per cent;<\/p>\n

\u2014 impurities C, D, E, F: for each impurity, maximum 0.05 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.05 per cent;<\/p>\n

\u2014 total: maximum 0.2 per cent;<\/p>\n

\u2014 reporting threshold: 0.03 per cent.<\/p>\n

Halides expressed as chlorides (2.4.4)<\/h3>\n

Maximum 140 ppm.<\/p>\n

Dissolve 1.2 g in water R and dilute to 50 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

Sulfated ash (2.4.14)<\/h3>\n

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

ASSAY<\/h2>\n

Dissolve 0.140 g in 20 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 15.72 mg of C8<\/sub>H15<\/sub>NO2<\/sub><\/p>\n

IMPURITIES<\/h2>\n

Specified impurities B, C, D, E, F.<\/p>\n

Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A.<\/p>\n

\"Tranexamic<\/p>\n

A. (1r,4r,1\u2032r,4\u2032r)-4,4\u2032-[azanediylbis(methylene)]di(cyclohexane-1-carboxylic acid),<\/p>\n

\"Tranexamic<\/p>\n

B. (1s,4s)-4-(aminomethyl)cyclohexane-1-carboxylic acid,<\/p>\n

\"Tranexamic<\/p>\n

C. (4RS)-4-(aminomethyl)cyclohex-1-ene-1-carboxylic acid,<\/p>\n

\"Tranexamic<\/p>\n

D. 4-(aminomethyl)benzoic acid,<\/p>\n

\"Tranexamic<\/p>\n

E. (1r,4r)-4-[[(1r,4r)-4-(aminomethyl)cyclohexane-1-carboxamido]methyl]cyclohexane-1-carboxylic acid,<\/p>\n

\"Tranexamic<\/p>\n

F. (1r,4r)-4-(formamidomethyl)cyclohexane-1-carboxylic acid.<\/p>\n

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

Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 0875) C8H15NO2 157.2 1197-18-8 Action and use Antifibrinolytic. Preparations Tranexamic Acid Injection Tranexamic Acid Mouthwash Tranexamic Acid Oral Solution Tranexamic Acid Tablets Ph Eur DEFINITION (1r,4r)-4-(Aminomethyl)cyclohexane-1-carboxylic acid. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder….<\/p>\n","protected":false},"author":5,"featured_media":31701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31700","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31700","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=31700"}],"version-history":[{"count":6,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31700\/revisions"}],"predecessor-version":[{"id":31718,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31700\/revisions\/31718"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31701"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}