﻿{"id":28903,"date":"2025-11-10T09:09:00","date_gmt":"2025-11-10T02:09:00","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=28903"},"modified":"2025-11-10T09:09:00","modified_gmt":"2025-11-10T02:09:00","slug":"terbinafine-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/terbinafine-hydrochloride\/","title":{"rendered":"Terbinafine Hydrochloride"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<br \/>\nGeneral Notices<\/p>\n<p>Ph. Eur. monograph 1734<\/p>\n<figure id=\"attachment_28911\" aria-describedby=\"caption-attachment-28911\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28911\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-2.jpg\" alt=\"C21H26ClN 327.9 78628-80-5\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-2.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-2-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-2-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-2-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28911\" class=\"wp-caption-text\">C21H26ClN 327.9 78628-80-5<\/figcaption><\/figure>\n<p><strong>Action and use<\/strong><\/p>\n<p>Antifungal.<br \/>\nPreparation: Terbinafine Tablets Ph Eur<\/p>\n<h2>DEFINITION<\/h2>\n<p>(2E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.<\/p>\n<p>Content: 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Infrared absorption spectrophotometry (2.2.24). Comparison with terbinafine hydrochloride CRS.<br \/>\nB. It gives reaction (a) of chlorides (2.3.1) using anhydrous ethanol R as solvent.<\/p>\n<h2>TESTS<\/h2>\n<p>Related substances<br \/>\nLiquid chromatography (2.2.29). Carry out the test protected from light.<\/p>\n<p>Solvent mixture A: acetonitrile R, water R (50:50 V\/V).<br \/>\nSolvent mixture B: acetonitrile R, methanol R (40:60 V\/V).<br \/>\nBuffer solution: Dilute 2.0 mL of triethylamine R1 to 950 mL with water R. Adjust to pH 7.5 with a mixture of 5 volumes of glacial acetic acid R and 95 volumes of water R and dilute to 1000.0 mL with water R.<\/p>\n<p>Test solution: Dissolve 25 mg of the substance to be examined in solvent mixture A and dilute to 50.0 mL with solvent mixture A.<br \/>\nReference solution (a): Dissolve 5 mg of terbinafine for system suitability CRS (containing impurities B and E) in 10.0 mL of solvent mixture A.<br \/>\nReference solution (b): Dilute 1.0 mL of the test solution to 100.0 mL with solvent mixture A. Dilute 1.0 mL of this solution to 10.0 mL with solvent mixture A.<\/p>\n<p>Column:<\/p>\n<p>&#8211; size: l = 0.15 m, \u00d8 = 3.0 mm<\/p>\n<p>&#8211; stationary phase: spherical end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm)<\/p>\n<p>&#8211; temperature: 40 \u00b0C.<\/p>\n<p>Mobile phase:<br \/>\n&#8211; Mobile phase A: buffer solution, solvent mixture B (30:70 V\/V)<br \/>\n&#8211; Mobile phase B: buffer solution, solvent mixture B (5:95 V\/V)<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 84px;\">\n<tbody>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px;\">Time (min)<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">Mobile phase A (per cent V\/V)<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">Mobile phase B (per cent V\/V)<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px;\">0 &#8211; 4<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">100<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">0<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px;\">4 &#8211; 25<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">100 \u2192 0<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">0 \u2192 100<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px;\">25 &#8211; 30<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">0<\/td>\n<td style=\"width: 33.3333%; height: 21px;\">100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate 0.8 mL\/min.<br \/>\nDetection Spectrophotometer at 280 nm.<br \/>\nInjection 20 \u03bcL.<br \/>\nIdentification of impurities Use the chromatogram supplied with terbinafine for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities B and E.<br \/>\nRelative retention With reference to terbinafine (retention time = about 15 min): impurity B = about 0.9; impurity E = about 1.7.<br \/>\nSystem suitability Reference solution (a):<br \/>\n\u2014 resolution: minimum 2.0 between the peaks due to impurity B and terbinafine.<\/p>\n<p>Limits:<br \/>\n\u2014 correction factor: for the calculation of content, multiply the peak area of impurity E by 0.5;<br \/>\n\u2014 impurity B: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent);<br \/>\n\u2014 impurity E: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent);<br \/>\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);<br \/>\n\u2014 total: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<br \/>\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<p><strong>Loss on drying (2.2.32)<\/strong><\/p>\n<p>Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<br \/>\n<strong>Sulfated ash (2.4.14) <\/strong><\/p>\n<p>Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.250 g in 50 mL of ethanol (96 per cent) R, add 5 mL of 0.01 M hydrochloric acid. Titrate with 0.1 M sodium hydroxide determining the end-point potentiometrically (2.2.20). Read the volume added between the 2 points of inflexion.<\/p>\n<p>1 mL of 0.1 M sodium hydroxide is equivalent to 32.79 mg of C21H26ClN.<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities B, E.<\/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) A, C, D, F.<\/p>\n<figure id=\"attachment_28910\" aria-describedby=\"caption-attachment-28910\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28910\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-3.jpg\" alt=\"A. N-methyl-C-(naphthalen-1-yl)methanamine,\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-3.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-3-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-3-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-3-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28910\" class=\"wp-caption-text\">A. N-methyl-C-(naphthalen-1-yl)methanamine,<\/figcaption><\/figure>\n<figure id=\"attachment_28909\" aria-describedby=\"caption-attachment-28909\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28909\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-4.jpg\" alt=\"B. (2Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine (cis-terbinafine),\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-4.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-4-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-4-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-4-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28909\" class=\"wp-caption-text\">B. (2Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine (cis-terbinafine),<\/figcaption><\/figure>\n<figure id=\"attachment_28908\" aria-describedby=\"caption-attachment-28908\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28908\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-5.jpg\" alt=\"C. (2E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine (trans-isoterbinafine),\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-5.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-5-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-5-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-5-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28908\" class=\"wp-caption-text\">C. (2E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine (trans-isoterbinafine),<\/figcaption><\/figure>\n<figure id=\"attachment_28907\" aria-describedby=\"caption-attachment-28907\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28907\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-6.jpg\" alt=\"D. (2E)-N,6,6-trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine (4-methylterbinafine),\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-6.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-6-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-6-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-6-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28907\" class=\"wp-caption-text\">D. (2E)-N,6,6-trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine (4-methylterbinafine),ylmethyl)hept-2-en-4-yn-1-amine (trans-isoterbinafine),<\/figcaption><\/figure>\n<figure id=\"attachment_28906\" aria-describedby=\"caption-attachment-28906\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28906\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-7.jpg\" alt=\"E. (2E,4E)-4-(4,4-dimethylpent-2-yn-1-ylidene)-N,N\u2032-dimethyl-N,N\u2032-bis(naphthalen-1-ylmethyl)pent-2-ene-1,5-diamine,\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-7.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-7-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-7-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-7-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28906\" class=\"wp-caption-text\">E. (2E,4E)-4-(4,4-dimethylpent-2-yn-1-ylidene)-N,N\u2032-dimethyl-N,N\u2032-bis(naphthalen-1-ylmethyl)pent-2-ene-1,5-diamine,<\/figcaption><\/figure>\n<figure id=\"attachment_28905\" aria-describedby=\"caption-attachment-28905\" style=\"width: 1200px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-28905\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-8.jpg\" alt=\"F. (2Z)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine (cis-isoterbinafine).\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-8.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-8-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-8-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Terbinafine-Hydrochloride-8-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><figcaption id=\"caption-attachment-28905\" class=\"wp-caption-text\">F. (2Z)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine (cis-isoterbinafine).<\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Ph. Eur. monograph 1734 Action and use Antifungal. Preparation: Terbinafine Tablets Ph Eur DEFINITION (2E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride. Content: 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol&#8230;<\/p>\n","protected":false},"author":5,"featured_media":28912,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28903","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\/28903","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=28903"}],"version-history":[{"count":1,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28903\/revisions"}],"predecessor-version":[{"id":28924,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28903\/revisions\/28924"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28912"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28903"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28903"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28903"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}