Immunomodulator; treatment of multiple sclerosis.<\/p>\n
Ph Eur<\/p>\n
\n
DEFINITION<\/h2>\n
Tablets containing Teriflunomide (3036), for human use.<\/p>\n
They comply with the monograph Tablets (0478) and the following additional requirements.<\/em><\/p>\n Content<\/strong><\/p>\n 95.0 per cent to 105.0 per cent of the content of teriflunomide (C12<\/sub>H9<\/sub>F3<\/sub>N2<\/sub>O2<\/sub>) stated on the label.<\/p>\n A. Record the UV spectrum of the principal peak in the chromatograms obtained with the solutions used in the assay, with a diode array detector, in the range of 200-400 nm.<\/p>\n Results The UV spectrum of the principal peak in the chromatogram obtained with the test solution is similar to the UV spectrum of the principal peak in the chromatogram obtained with reference solution (d).<\/p>\n B. Examine the chromatograms obtained in the assay.<\/p>\n Results The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (d).<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Buffer solution<\/em> 3.85 g\/L solution of ammonium acetate R adjusted to pH 5.5 with glacial acetic acid R. Solvent mixture Buffer solution, acetonitrile R (20:80 V\/V).<\/p>\n Test solution<\/em> To 10 tablets, add a volume of the solvent mixture equivalent to about half of the final volume. Dissolve the tablets by shaking for approximately 20 min and sonicating for about 3 min. Dilute to volume with the solvent mixture to obtain a concentration of teriflunomide of 0.7 mg\/mL and filter. Dilute 3.0 mL of the filtrate to 10.0 mL with the solvent mixture.<\/p>\n Reference solution (a)<\/em>\u00a0 Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture.<\/p>\n Reference solution (b)<\/em> Dissolve 10 mg of leflunomide impurity A CRS (teriflunomide impurity A) in acetonitrile R and dilute to 250 mL with the same solvent. Dilute 1 mL of the solution to 200 mL with the solvent mixture.<\/p>\n Reference solution (c)<\/em> Dissolve 5 mg of teriflunomide impurity B CRS in acetonitrile R and dilute to 100 mL with the same solvent. Dilute 2 mL of the solution to 50 mL with the solvent mixture. To 1 mL of this solution add 1 mL of reference solution (b) and dilute to 10 mL with the solvent mixture.<\/p>\n Reference solution (d)\u00a0<\/em> Dissolve 21.0 mg of teriflunomide for assay CRS in 40 mL of the solvent mixture and dilute to Reference solution (e)<\/em>\u00a0 Dilute 1.0 mL of reference solution (a) to 10.0 mL with the solvent mixture.<\/p>\n Column:<\/em><\/p>\n \u2014 size: l<\/em> = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase:<\/em> end-capped solid core octadecylsilyl silica gel for chromatography R (2.7 \u00b5m);<\/p>\n \u2014 temperature:<\/em> 40 \u00b0C.<\/p>\n Mobile phase:<\/em><\/p>\n \u2014 mobile phase A:<\/em> acetonitrile for chromatography R, buffer solution (10:90 V\/V);<\/p>\n \u2014 mobile phase B:<\/em> buffer solution, acetonitrile for chromatography R (10:90 V\/V);<\/p>\n Flow rate<\/em>\u00a0 1.0 mL\/min.<\/p>\n Detection<\/em>\u00a0 Spectrophotometer at 249 nm.<\/p>\n Injection<\/em>\u00a0 5 \u00b5L of the test solution and reference solutions (c) and (e).<\/p>\n Identification of impurities<\/em> Use the chromatogram obtained with reference solution (c) to identify the peaks due to impurities A and B.<\/p>\n Relative retention<\/em> With reference to teriflunomide (retention time = about 5 min): impurity B = about 1.5; impurity A = about 1.6.<\/p>\n System suitability<\/em>\u00a0 Reference solution (c):<\/p>\n \u2014 resolution<\/em>: minimum 1.5 between the peaks due to impurities B and A;<\/p>\n \u2014 signal-to-noise ratio:<\/em> minimum 10 for the peak due to impurity A.<\/p>\n Calculation of percentage contents:<\/em><\/p>\n \u2014 for each impurity, use the concentration of teriflunomide in reference solution (e).<\/p>\n Limits:<\/em><\/p>\n \u2014 impurity A:<\/em> maximum 0.01 per cent;<\/p>\n \u2014 impurity B:<\/em> maximum 0.30 per cent;<\/p>\n \u2014 unspecified impurities<\/em>: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total:<\/em> maximum 0.40 per cent;<\/p>\n \u2014 reporting threshold:<\/em> 0.05 per cent; do not disregard the peak due to impurity A.<\/p>\n Dissolution1<\/sup> (2.9.3, Apparatus 2).<\/strong><\/p>\n Dissolution medium<\/em>\u00a0 6.8 g\/L solution of potassium dihydrogen phosphate R adjusted to pH 6.8 with a 200 g\/L solution of sodium hydroxide R. Use 1000 mL of the medium.<\/p>\n Rotation speed<\/em>\u00a0 50 r\/min.<\/p>\n Time<\/em>\u00a0 30 min.<\/p>\n Analysis<\/em>\u00a0 Ultraviolet and visible absorption spectrophotometry (2.2.25).<\/p>\n Test solution<\/em> Samples withdrawn from the dissolution vessel and filtered. Measure the absorbance of the solutions at the absorption maximum at 292 nm.<\/p>\n Calculate the amount of dissolved teriflunomide (C12<\/sub>H9<\/sub>F3<\/sub>N2<\/sub>O2<\/sub>), expressed as a percentage of the content stated on the label, taking the specific absorbance to be 854.<\/p>\n Acceptance criterion:<\/em><\/p>\n \u2014 Q = 75 per cent after 30 min.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n Injection<\/em>\u00a0 Test solution and reference solution (d).<\/p>\n System suitability<\/em>\u00a0 Reference solution (d):<\/p>\n \u2014 symmetry factor:<\/em> maximum 2.0 for the peak due to teriflunomide;<\/p>\n \u2014 repeatability:<\/em> maximum relative standard deviation of 1.5 per cent determined on 6 injections.<\/p>\n Calculate the percentage content of teriflunomide (C12<\/sub>H9<\/sub>F3<\/sub>N2<\/sub>O2<\/sub>) taking into account the assigned content of teriflunomide for assay CRS.<\/p>\n Specified impurities\u00a0 A, B.<\/p>\n A. 4-(trifluoromethyl)aniline (leflunomide impurity A),<\/p>\n B. 2-cyano-N-[4-(trifluoromethyl)phenyl]acetamide.<\/p>\n Ph Eur<\/p>\n 1\u00a0<\/sup> The test approved in the marketing authorisation is to be used for routine quality control to confirm batch-to-batch consistency. For more information please consult Ph. Eur. 1. General Notices.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Immunomodulator; treatment of multiple sclerosis. Ph Eur DEFINITION Tablets containing Teriflunomide (3036), for human use. They comply with the monograph Tablets (0478) and the following additional requirements. Content 95.0 per cent to 105.0 per cent of the content of teriflunomide (C12H9F3N2O2) stated on the label….<\/p>\n","protected":false},"author":5,"featured_media":22142,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22131","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22131","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=22131"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22131\/revisions"}],"predecessor-version":[{"id":22378,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22131\/revisions\/22378"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22142"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22131"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22131"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22131"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\n100.0 mL with the solvent mixture.<\/p>\n\n\n
\n Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n \n 0-2<\/td>\n 76<\/td>\n 24<\/td>\n<\/tr>\n \n 2-12<\/td>\n 76 \u2192 23<\/td>\n 24 \u2192 77<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n ASSAY<\/h2>\n
IMPURITIES<\/h2>\n
![\"Teriflunomide](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Teriflunomide-Tablets-British-Pharmacopoeia-2025-1.jpg\")
<\/p>\n![\"Teriflunomide](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Teriflunomide-Tablets-British-Pharmacopoeia-2025-2.jpg\")
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