![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-2.jpg\")
<\/p>\nBP 2025 (Ph. Eur. 11.6 update)<\/p>\n
<\/p>\n
C24<\/sub>H30<\/sub>N2<\/sub>O4<\/sub> 410.5 521-78-8<\/p>\n Action and use<\/strong><\/p>\n Monoamine reuptake inhibitor; tricyclic antidepressant.<\/p>\n Preparation<\/strong><\/p>\n Trimipramine Tablets<\/p>\n (2RS)-3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine hydrogen (2Z)-but-2-enedioate.<\/p>\n Content<\/p>\n 98.0 per cent to 101.0 per cent (dried substance).<\/p>\n Appearance<\/strong><\/p>\n White or almost white, crystalline powder.<\/p>\n Solubility<\/strong><\/p>\n Slightly soluble in water and in ethanol (96 per cent).<\/p>\n A. Melting point (2.2.14): 140 \u00b0C to 144 \u00b0C. Comparison trimipramine maleate CRS.<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29). Carry out the test protected from light.<\/p>\n Buffer solution pH 7.7 2.64 g\/L solution of ammonium phosphate R in water for chromatography R; adjust to pH 7.7 with phosphoric acid R. Column: Mobile phase acetonitrile R1, buffer solution pH 7.7 (38:62 V\/V). System suitability: Limits: \u2014 impurities A, B, C, D: for each impurity, not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent); Loss on drying (2.2.32)<\/strong> Sulfated ash (2.4.14)<\/strong> Dissolve 0.350 g in 50 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). Protected from light.<\/p>\n Specified impurities A, B, C, D, E, F. BP 2025 (Ph. Eur. 11.6 update) C24H30N2O4 410.5 521-78-8 Action and use Monoamine reuptake inhibitor; tricyclic antidepressant. Preparation Trimipramine Tablets DEFINITION (2RS)-3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine hydrogen (2Z)-but-2-enedioate. Content 98.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Slightly soluble in water and in ethanol (96 per cent). IDENTIFICATION A….<\/p>\n","protected":false},"author":5,"featured_media":32102,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-32100","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\/32100","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=32100"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32100\/revisions"}],"predecessor-version":[{"id":32115,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32100\/revisions\/32115"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/32102"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=32100"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=32100"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=32100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
\nB. Infrared absorption spectrophotometry (2.2.24).<\/p>\nTESTS<\/h2>\n
\nTest solution Dissolve 50 mg of the substance to be examined in the mobile phase and dilute to 100 mL with the mobile phase.
\nReference solution (a) Dissolve 5 mg of the substance to be examined and 5 mg of iminodibenzyl R (impurity F) in the mobile phase and dilute to 10 mL with the mobile phase.
\nReference solution (b) Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.
\nReference solution (c) Dissolve the contents of a vial of trimipramine for peak identification CRS (containing impurities A, B, C, D and E) in 1 mL of acetonitrile R1.<\/p>\n
\n\u2014 size: l = 0.125 m, \u00d8 = 4.0 mm;
\n\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n
\nFlow rate 1.5 mL\/min.
\nDetection Spectrophotometer at 210 nm.
\nInjection 20 \u03bcL.
\nRun time 3 times the retention time of trimipramine.
\nIdentification of impurities Use the chromatogram supplied with trimipramine for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities A, B, C, D and E; doubling of the peak due to impurity E may be observed.
\nRelative retention With reference to trimipramine (retention time = about 27 min): impurity A = about 0.1; impurity B = about 0.3; impurity C = about 0.4; impurity D = about 0.5; impurity F = about 1.4; impurity E = about 1.5.<\/p>\n
\n\u2014 resolution: minimum 3.5 between the peaks due to trimipramine and impurity F in the chromatogram obtained with reference solution (a);
\n\u2014 the chromatogram obtained with reference solution (c) is similar to the chromatogram supplied with trimipramine for peak identification CRS.<\/p>\n
\n\u2014 correction factor: for the calculation of content, multiply the peak area of impurity F by 0.5;
\n\u2014 impurity E: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);
\n\u2014 impurity F: not more than 2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n
\n\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);
\n\u2014 total: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
\n\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n
\nMaximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n
\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\nASSAY<\/h2>\n
\n1 mL of 0.1 M perchloric acid is equivalent to 41.05 mg of C24<\/sub>H30<\/sub>N2<\/sub>O4<\/sub>.<\/p>\nSTORAGE<\/h2>\n
IMPURITIES<\/h2>\n
\nOther 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) G.<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-3.jpg\")
\nA. (2RS)-3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine N-oxide,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-4.jpg\")
\nB. (2RS)-3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,2-dimethylpropan-1-amine,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-5.jpg\")
\nC. (2RS)-3-(5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-6.jpg\")
\nD. imipramine,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-7-1.jpg\")
\nE. mixture of the stereoisomers of N-[3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-2-methylpropyl]-N,N\u2032,N\u2032,2- tetramethylpropane-1,3-diamine,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-8.jpg\")
\nF. 10,11-dihydro-5H-dibenzo[b,f]azepine,<\/p>\n![\"Trimipramine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Trimipramine-Maleate-9.jpg\")
\nG. 2-methyl-10,11-dihydro-5H-dibenzo[b,f]azepine.<\/p>\n","protected":false},"excerpt":{"rendered":"