![\"C13H18ClN3](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/C13H18ClN3-H2O.jpg\")
<\/p>\n(Ph. Eur. 11.6 update)<\/p>\n
(Ph. Eur. monograph 1597)<\/p>\n
<\/p>\n
C13<\/sub>H18<\/sub>ClN3<\/sub> \u00b7 H2<\/sub>O\u00a0 \u00a0 \u00a0 \u00a0 269.8\u00a0 \u00a0 \u00a0 74195-73-6<\/p>\n Action and use<\/strong><\/p>\n Alpha-adrenoceptor agonist.<\/p>\n Ph Eur<\/p>\n N-(5,6,7,8-Tetrahydronaphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine hydrochloride monohydrate.<\/p>\n Content<\/strong><\/p>\n 98.5 per cent to 101.5 per cent (anhydrous substance).<\/p>\n Appearance<\/strong><\/p>\n White or almost white, crystalline powder.<\/p>\n Solubility<\/strong><\/p>\n Soluble in water and in ethanol (96 per cent).<\/p>\n A. Infrared absorption spectrophotometry (2.2.24). Comparison tramazoline hydrochloride monohydrate CRS.<\/p>\n B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n Solution S<\/strong><\/p>\n Dissolve 2.5 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent.<\/p>\n Appearance of solution<\/strong><\/p>\n Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method II).<\/p>\n pH (2.2.3).<\/p>\n 4.9 to 6.3 for solution S.<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Solvent mixture<\/p>\n Acetonitrile R, water R (50:50 V\/V).<\/p>\n Test solution<\/p>\n Dissolve 50.0 mg of the substance to be examined in the solvent mixture and dilute to 50.0 mL with the solvent mixture.<\/p>\n Reference solution (a)<\/p>\n Dissolve 5.0 mg of tramazoline impurity A CRS and 5.0 mg of tramazoline impurity B CRS in 5 mL of the solvent mixture and add 5 mL of the test solution.<\/p>\n Reference solution (b)<\/p>\n Dilute 0.2 mL of reference solution (a) to 100 mL with the solvent mixture.<\/p>\n Column<\/p>\n \u2014 size: l = 0.125 m, \u00d8 = 4 mm;<\/p>\n \u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n Mobile phase. 2.0 g\/L solution of sodium dodecyl sulfate R in a mixture of 6 volumes of 2-propanol R, 42 volumes of acetonitrile R1 and 52 volumes of water for chromatography R.<\/p>\n Flow rate. 1.2 mL\/min.<\/p>\n Detection. Spectrophotometer at 215 nm.<\/p>\n Injection. 5 \u03bcL.<\/p>\n Run time. 3 times the retention time of tramazoline.<\/p>\n Relative retention. With reference to tramazoline (retention time = about 6.5 min): impurity A = about 0.71; impurity B = about 0.86.<\/p>\n System suitability<\/p>\n Reference solution (a):<\/p>\n \u2014 the chromatogram obtained shows 3 clearly separated peaks;<\/p>\n \u2014 resolution: minimum 1.5 between the peak due to impurity B and tramazoline.<\/p>\n Limits<\/p>\n \u2014 impurities A, B: for each impurity, not more than 3 times the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n \u2014 sum of impurities other than A and B: not more than twice the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n \u2014 disregard limit: 0.2 times the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.02 per cent).<\/p>\n Water (2.5.12)<\/p>\n 6.2 per cent to 7.2 per cent, determined on 0.500 g.<\/p>\n Sulfated ash (2.4.14)<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 2.000 g in a mixture of 5 mL of 0.1 M hydrochloric acid and 75 mL of ethanol (96 per cent) R. Carry out a potentiometric titration (2.2.20) using 1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n 1 mL of 1 M sodium hydroxide is equivalent to 251.8 mg of C13H18ClN3.<\/p>\n Specified impurities A, B.<\/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. 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 A. N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine,<\/p>\n B. 1-[2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazol-1-yl]ethan-1-one,<\/p>\n C. 1-[(1Z)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)ethanimidoyl]imidazolidin-2-one.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1597) C13H18ClN3 \u00b7 H2O\u00a0 \u00a0 \u00a0 \u00a0 269.8\u00a0 \u00a0 \u00a0 74195-73-6 Action and use Alpha-adrenoceptor agonist. Ph Eur DEFINITION N-(5,6,7,8-Tetrahydronaphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine hydrochloride monohydrate. Content 98.5 per cent to 101.5 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Soluble in water and in ethanol (96…<\/p>\n","protected":false},"author":4,"featured_media":31395,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31389","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\/31389","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=31389"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31389\/revisions"}],"predecessor-version":[{"id":31398,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31389\/revisions\/31398"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31395"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
ASSAY<\/h2>\n
IMPURITIES<\/h2>\n
![\"A.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/A.-N-naphthalen-1-yl-45-dihydro-1H-imidazol-2-amine.jpg\")
<\/p>\n![\"B.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/B.-1-2-5678-tetrahydronaphthalen-1-ylamino-45-dihydro-1H-imidazol-1-ylethan-1-one.jpg\")
<\/p>\n![\"C.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/C.-1-1Z-N-5678-tetrahydronaphthalen-1-ylethanimidoylimidazolidin-2-one.jpg\")
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