{"id":29889,"date":"2025-11-11T11:16:27","date_gmt":"2025-11-11T04:16:27","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29889"},"modified":"2025-11-11T11:16:27","modified_gmt":"2025-11-11T04:16:27","slug":"rupatadine-fumarate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/rupatadine-fumarate\/","title":{"rendered":"Rupatadine Fumarate"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 2888)<\/em><\/p>\n<p>C<sub>30<\/sub>H<sub>30<\/sub>ClN<sub>3<\/sub>O<sub>4<\/sub> 532.0 182349-12-8<\/p>\n<h2>DEFINITION<\/h2>\n<p>8-Chloro-11-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (2E)- but-2-enedioate.<\/p>\n<h3>Content<\/h3>\n<p>98.0 per cent to 100.5 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or slightly pinkish powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Very slightly soluble in water, slightly soluble in anhydrous ethanol, very slightly soluble in heptane.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison: rupatadine fumarate CRS.<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n<p>Solvent mixture acetonitrile R, mobile phase A (20:80 V\/V).<\/p>\n<p>Test solution: Dissolve 32.0 mg of the substance to be examined in the solvent mixture and dilute to 50.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (b): Dissolve 3 mg of rupatadine for system suitability CRS (containing impurities A and B) in the solvent mixture and dilute to 5 mL with the solvent mixture.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n<p>\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n<p>\u2014 temperature: 30 \u00b0C.<\/p>\n<p>Mobile phase:<\/p>\n<p>\u2014 mobile phase A: 7.0 g\/L solution of sodium dihydrogen phosphate monohydrate R in water for chromatography R;<\/p>\n<p>\u2014 mobile phase B: acetonitrile R1;<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 63px;\">\n<tbody>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Time<\/strong><br \/>\n<strong>(min)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase A<\/strong><br \/>\n<strong>(per cent V\/V)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase B<\/strong><br \/>\n<strong>(per cent V\/V)<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0 &#8211; 2<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">80<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">20<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">2 &#8211; 27<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">80 \u2192 50<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">20 \u2192 50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate: 1.2 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 210 nm.<\/p>\n<p>Injection: 50 \u03bcL.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with rupatadine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n<p>Relative retention: With reference to rupatadine (retention time = about 17 min): fumaric acid = about 0.1; impurity A = about 0.6; impurity B = about 0.7.<\/p>\n<p>System suitability: Reference solution (b):<\/p>\n<p>\u2014 resolution: minimum 5.0 between the peaks due to impurities A and B.<\/p>\n<p>Calculation of percentage contents:<\/p>\n<p>\u2014 correction factor: multiply the peak area of impurity A by 1.3;<\/p>\n<p>\u2014 for each impurity, use the concentration of rupatadine fumarate in reference solution (a).<\/p>\n<p>Limits:<\/p>\n<p>\u2014 impurity B: maximum 0.5 per cent;<\/p>\n<p>\u2014 impurity A: maximum 0.15 per cent;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n<p>\u2014 total: maximum 0.7 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.05 per cent; disregard the peak due to fumaric acid.<\/p>\n<h3>Loss on drying (2.2.32)<\/h3>\n<p>Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo in an oven at 80 \u00b0C for 3 h.<\/p>\n<h3>Sulfated ash (2.4.14)<\/h3>\n<p>Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.150 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n<p>1 mL of 0.1 M perchloric acid is equivalent to 17.73 mg of C<sub>30<\/sub>H<sub>30<\/sub>ClN<sub>3<\/sub>O<sub>4<\/sub> .<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, B.<\/p>\n<p>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) C.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-29907\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-68-300x163.jpg\" alt=\"Rupatadine Fumarate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-68-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-68-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-68-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-68.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. 3-[[4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidin-1-yl]methyl]-1-(1,2- dicarboxyethyl)-5-methylpyridin-1-ium,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-29908\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-67-300x163.jpg\" alt=\"Rupatadine Fumarate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-67-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-67-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-67-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-67.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-29909\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-65-300x163.jpg\" alt=\"Rupatadine Fumarate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-65-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-65-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-65-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-65.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 11,11\u2032-[pyridine-3,5-diylbis(methylenepiperidin-1-yl-4-ylidene)]bis(8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 2888) C30H30ClN3O4 532.0 182349-12-8 DEFINITION 8-Chloro-11-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (2E)- but-2-enedioate. Content 98.0 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or slightly pinkish powder. Solubility Very slightly soluble in water, slightly soluble in anhydrous ethanol, very slightly soluble in heptane. IDENTIFICATION Infrared absorption spectrophotometry (2.2.24). Comparison: rupatadine fumarate CRS. TESTS Related&#8230;<\/p>\n","protected":false},"author":4,"featured_media":29906,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29889","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\/29889","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=29889"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29889\/revisions"}],"predecessor-version":[{"id":29912,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29889\/revisions\/29912"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29906"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29889"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29889"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}