{"id":1403,"date":"2025-09-19T09:13:00","date_gmt":"2025-09-19T02:13:00","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=1403"},"modified":"2025-11-15T10:41:52","modified_gmt":"2025-11-15T03:41:52","slug":"adrenaline-acid-tartrate-epinephrine-acid-tartrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/adrenaline-acid-tartrate-epinephrine-acid-tartrate\/","title":{"rendered":"Adrenaline Acid Tartrate \/ Epinephrine Acid Tartrate"},"content":{"rendered":"<p><em>(Adrenaline Tartrate, Ph. Eur. monograph 0254)<\/em><\/p>\n<p>C<sub>13<\/sub>H<sub>19<\/sub>NO<sub>9<\/sub> 333.3 51-42-3<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Adrenoceptor agonist.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Adrenaline Injection\/Epinephrine Injection<\/p>\n<p>Dilute Adrenaline Injection (1 in 10,000)\/Dilute Epinephrine Injection (1 in 10,000)<\/p>\n<p>Adrenaline Solution\/Epinephrine Solution<\/p>\n<p>Adrenaline and Cocaine Intranasal Solution<\/p>\n<p>Bupivacaine and Adrenaline Injection\/Bupivacaine and Epinephrine Injection<\/p>\n<p>Lidocaine and Adrenaline Injection\/Lidocaine and Epinephrine Injection<\/p>\n<h2>DEFINITION<\/h2>\n<p>(1R)-1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol hydrogen (2R,3R)-2,3-dihydroxybutanedioate.<\/p>\n<h3>Content<\/h3>\n<p>98.5 per cent to 101.0 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or greyish-white, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Freely soluble in water, slightly soluble in ethanol (96 per cent).<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Dissolve 5 g in 50 mL of a 5 g\/L solution of sodium metabisulfite R and make alkaline by addition of ammonia R. Keep the mixture at room temperature for at least 15 min and filter. Reserve the filtrate for identification test C. Wash the precipitate with 3 quantities, each of 10 mL, of methanol R. Dry at 80 \u00b0C. The specific optical rotation (2.2.7) of the residue (adrenaline base) is -53.5 to -50, determined using a 20.0 g\/L solution in 0.5 M hydrochloric acid.<\/p>\n<p>B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p><em>Preparation:<\/em>\u00a0Discs of adrenaline base prepared as described under identification test A.<\/p>\n<p><em>Comparison:<\/em> Use adrenaline base prepared as described under identification test A from 50 mg of adrenaline<br \/>\ntartrate CRS dissolved in 5 mL of a 5 g\/L solution of sodium metabisulfite R. Keep the mixture at room temperature for at least 30 min. Filter through a sintered-glass filter (2.1.2).<\/p>\n<p>C. 0.2 mL of the filtrate obtained in identification test A gives reaction (b) of tartrates (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution BY5 (2.2.2, Method II).<\/p>\n<p>Dissolve 0.5 g in water R and dilute to 10 mL with the same solvent. Examine the solution immediately.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29). Prepare the solutions protected from light.<\/p>\n<p><em>Solvent mixture A:<\/em>\u00a0Dissolve 5.0 g of potassium dihydrogen phosphate R and then 2.6 g of sodium octanesulfonate R in water for chromatography R, and dilute to 1000 mL with the same solvent (it is usually necessary to stir for at least 30 min to achieve complete dissolution). Adjust to pH 2.8 with phosphoric acid R.<\/p>\n<p><em>Solvent mixture B:<\/em>\u00a0acetonitrile R1, solvent mixture A (130:870 V\/V).<\/p>\n<p><em>Test solution:<\/em>\u00a0Dissolve 75 mg of the substance to be examined in 5 mL of 0.1 M hydrochloric acid and dilute to 50 mL with solvent mixture B.<\/p>\n<p><em>Reference solution (a):<\/em>\u00a0Dilute 1.0 mL of the test solution to 100.0 mL with solvent mixture B. Dilute 1.0 mL of this solution to 10.0 mL with solvent mixture B.<\/p>\n<p><em>Reference solution (b):<\/em>\u00a0Dissolve 1.5 mg of noradrenaline tartrate CRS (impurity B) and 1.5 mg of adrenalone<br \/>\nhydrochloride R (impurity C) in solvent mixture B, add 1.0 mL of the test solution and dilute to 100.0 mL with solvent mixture B.<\/p>\n<p><em>Reference solution (c):<\/em>\u00a0Dissolve the contents of a vial of adrenaline impurity mixture CRS (impurities D and E) in 0.1 mL of 0.1 M hydrochloric acid and 0.9 mL of solvent mixture B.<\/p>\n<p><em>Reference solution (d):<\/em>\u00a0Dissolve 7.5 mg of adrenaline tartrate with impurity A CRS in 0.5 mL of 0.1 M hydrochloric acid and dilute to 5.0 mL with solvent mixture B.<\/p>\n<p><em>Blank solution:<\/em>\u00a00.1 M hydrochloric acid, solvent mixture B (1:9 V\/V).<\/p>\n<p><em>Column:<\/em><\/p>\n<p><em>\u2014 size:<\/em> l = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n<p><em>\u2014 stationary phase:<\/em> end-capped octadecylsilyl silica gel for chromatography R (3 \u03bcm);<\/p>\n<p>\u2014 temperature: 50 \u00b0C.<\/p>\n<p><em>Mobile phase:<\/em><\/p>\n<p><em>\u2014 mobile phase A:<\/em> acetonitrile R1, solvent mixture A (5:95 V\/V);<\/p>\n<p><em>\u2014 mobile phase B:<\/em> acetonitrile R1, solvent mixture A (45:55 V\/V);<\/p>\n<p>&nbsp;<\/p>\n<table style=\"border-collapse: collapse; width: 100%;\">\n<tbody>\n<tr>\n<td style=\"width: 33.3333%; text-align: center;\"><strong>Time<\/strong><\/p>\n<p><strong>(min)<\/strong><\/td>\n<td style=\"width: 33.3333%; text-align: center;\"><strong>Mobile phase A<\/strong><\/p>\n<p><strong>(per cent V\/V)<\/strong><\/td>\n<td style=\"width: 33.3333%; text-align: center;\"><strong>Mobile phase B<\/strong><\/p>\n<p><strong>(per cent V\/V)<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 33.3333%; text-align: center;\">0 &#8211; 15<\/p>\n<p>15 &#8211; 20<\/p>\n<p>20 &#8211; 25<\/td>\n<td style=\"width: 33.3333%; text-align: center;\">92 \u2192 50<\/p>\n<p>50 \u2192 92<\/p>\n<p>92<\/td>\n<td style=\"width: 33.3333%; text-align: center;\">8 \u2192 50<\/p>\n<p>50 \u2192 8<\/p>\n<p>8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><em>Flow rate:<\/em>\u00a02.0 mL\/min.<\/p>\n<p><em>Detection:<\/em>\u00a0Spectrophotometer at 210 nm.<\/p>\n<p><em>Injection:<\/em>\u00a020 \u03bcL.<\/p>\n<p><em>Identification of impurities:<\/em>\u00a0Use the chromatogram supplied with adrenaline impurity mixture CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities D and E; use the chromatogram supplied with adrenaline tartrate with impurity A CRS and the chromatogram obtained with reference solution (d) to identify the peak due to impurity A.<\/p>\n<p><em>Relative retention:<\/em>\u00a0With reference to adrenaline (retention time = about 4 min): impurity B = about 0.8;<br \/>\nimpurity C = about 1.3; impurity A = about 3.2; impurity D = about 3.3; impurity E = about 3.7.<\/p>\n<p><em>System suitability:<\/em>\u00a0Reference solution (b):<\/p>\n<p><em>\u2014 resolution:<\/em> minimum 3.0 between the peaks due to impurity B and adrenaline.<\/p>\n<p><em>Limits:<\/em><\/p>\n<p><em>\u2014 correction factors:<\/em> for the calculation of content, multiply the peak areas of the following impurities by the<br \/>\ncorresponding correction factor: impurity D = 0.7; impurity E = 0.6;<\/p>\n<p><em>\u2014 impurity A:<\/em> not more than 3 times the area of the principal peak in the chromatogram obtained with reference<br \/>\nsolution (a) (0.3 per cent);<\/p>\n<p><em>\u2014 impurities B, C:<\/em> for each impurity, not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n<p><em>\u2014 impurities D, E:<\/em> for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent);<\/p>\n<p><em>\u2014 unspecified impurities:<\/em> for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n<p><em>\u2014 total:<\/em> not more than 6 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.6 per cent);<\/p>\n<p><em>\u2014 disregard limit:<\/em> 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/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 for 18 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 0.300 g in 50 mL of anhydrous acetic acid R, heating gently if necessary. Titrate with 0.1 M perchloric acid until a bluish-green colour is obtained, using 0.1 mL of crystal violet solution R as indicator.<\/p>\n<p>1 mL of 0.1 M perchloric acid is equivalent to 33.33 mg of C13H19NO9.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container, or preferably in a sealed tube under vacuum or under an inert gas, protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, B, C, D, E.<\/p>\n<p>A. unknown structure,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-7281\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/3-177-300x163.jpg\" alt=\"Adrenaline Acid Tartrate - Epinephrine Acid Tartrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/3-177-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/3-177-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/3-177-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/3-177.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. (1R)-2-amino-1-(3,4-dihydroxyphenyl)ethanol (noradrenaline),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-7282\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/4-160-300x163.jpg\" alt=\"Adrenaline Acid Tartrate - Epinephrine Acid Tartrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/4-160-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/4-160-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/4-160-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/4-160.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 1-(3,4-dihydroxyphenyl)-2-(methylamino)ethanone (adrenalone),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-7283\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/5-140-300x163.jpg\" alt=\"Adrenaline Acid Tartrate - Epinephrine Acid Tartrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/5-140-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/5-140-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/5-140-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/5-140.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>D. 4-[(1R)-2-(benzylmethylamino)-1-hydroxyethyl]benzene-1,2-diol,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-7284\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/6-123-300x163.jpg\" alt=\"Adrenaline Acid Tartrate - Epinephrine Acid Tartrate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/6-123-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/6-123-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/6-123-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/6-123.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>E. 2-(benzylmethylamino)-1-(3,4-dihydroxyphenyl)ethanone.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Adrenaline Tartrate, Ph. Eur. monograph 0254) C13H19NO9 333.3 51-42-3 Action and use Adrenoceptor agonist. Preparations Adrenaline Injection\/Epinephrine Injection Dilute Adrenaline Injection (1 in 10,000)\/Dilute Epinephrine Injection (1 in 10,000) Adrenaline Solution\/Epinephrine Solution Adrenaline and Cocaine Intranasal Solution Bupivacaine and Adrenaline Injection\/Bupivacaine and Epinephrine Injection Lidocaine and Adrenaline Injection\/Lidocaine and Epinephrine Injection DEFINITION (1R)-1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol hydrogen (2R,3R)-2,3-dihydroxybutanedioate&#8230;.<\/p>\n","protected":false},"author":4,"featured_media":1433,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-1403","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\/1403","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=1403"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/1403\/revisions"}],"predecessor-version":[{"id":7288,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/1403\/revisions\/7288"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/1433"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=1403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=1403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=1403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}