{"id":10496,"date":"2025-10-08T10:12:41","date_gmt":"2025-10-08T03:12:41","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=10496"},"modified":"2025-10-08T10:12:41","modified_gmt":"2025-10-08T03:12:41","slug":"econazole-nitrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/econazole-nitrate\/","title":{"rendered":"Econazole Nitrate"},"content":{"rendered":"<p>(Ph. Eur. monograph 0665)<\/p>\n<p>C<sub>18<\/sub>H<sub>16<\/sub>Cl<sub>3<\/sub>N<sub>3<\/sub>O<sub>4<\/sub>\u00a0 \u00a0444.7\u00a0 \u00a024169-02-6<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Antifungal.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Econazole Cream<\/p>\n<p>Econazole Pessaries<\/p>\n<h2>DEFINITION<\/h2>\n<p>1-[(2RS)-2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole nitrate.<\/p>\n<h3>Content<\/h3>\n<p>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, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Very slightly soluble in water, soluble in methanol, sparingly soluble in methylene chloride, slightly soluble in ethanol (96 per cent).<\/p>\n<h3>mp<\/h3>\n<p>About 165 \u00b0C, with decomposition.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison econazole nitrate CRS.<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29).<\/p>\n<p>Test solution: Dissolve 0.100 g of the substance to be examined in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n<p>Reference solution (a): Dissolve 10 mg of econazole for system suitability CRS (containing impurities A, B and C) in methanol R and dilute to 1.0 mL with the same solvent.<\/p>\n<p>Reference solution (b): Dilute 1.0 mL of the test solution to 20.0 mL with methanol R. Dilute 1.0 mL of this solution to 25.0 mL with methanol R.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n<p>\u2014 stationary phase: base-deactivated octadecylsilyl silica gel for chromatography R (3 \u03bcm);<\/p>\n<p>\u2014 temperature: 35 \u00b0C.<\/p>\n<p>Mobile phase:<\/p>\n<p>\u2014 mobile phase A: methanol R, 0.77 g\/L solution of ammonium acetate R (20:80 V\/V);<\/p>\n<p>\u2014 mobile phase B: methanol R, acetonitrile R (40:60 V\/V);<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 85px;\">\n<tbody>\n<tr style=\"height: 43px;\">\n<td style=\"width: 33.3333%; height: 43px; text-align: center;\">Time<br \/>\n(min)<\/td>\n<td style=\"width: 33.3333%; height: 43px; text-align: center;\">Mobile phase A<br \/>\n(per cent V\/V)<\/td>\n<td style=\"width: 33.3333%; height: 43px; text-align: center;\">Mobile phase B<br \/>\n(per cent V\/V)<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0 &#8211; 25<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">60 \u2192 10<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">\u00a040 \u2192 90<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">25 &#8211; 27<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">10<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate 1.5 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 225 nm.<\/p>\n<p>Injection 10 \u03bcL.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with econazole for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B and C.<\/p>\n<p>Relative retention: With reference to econazole (retention time = about 15 min): impurity A = about 0.2;<br \/>\nimpurity B = about 0.6; impurity C = about 1.1.<\/p>\n<p>System suitability Reference solution (a):<\/p>\n<p>\u2014 peak-to-valley ratio: minimum 1.5, where Hp = height above the baseline of the peak due to impurity C and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to econazole.<\/p>\n<p>Limits:<\/p>\n<p>\u2014 correction factor: for the calculation of content, multiply the peak area of impurity A by 1.4;<\/p>\n<p>\u2014 impurities A, B, C: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than 0.5 times the area of the principal peak in the<br \/>\nchromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n<p>\u2014 total: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<\/p>\n<p>\u2014 disregard limit: 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent); disregard the peak due to the nitrate ion at the beginning of the chromatogram.<\/p>\n<h4>Loss on drying (2.2.32)<\/h4>\n<p>Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 4 h.<\/p>\n<h4>Sulfated ash (2.4.14)<\/h4>\n<p>Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.400 g in 50 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). Carry out a blank titration.<\/p>\n<p>1 mL of 0.1 M perchloric acid is equivalent to 44.47 mg of C<sub>18<\/sub>H<sub>16<\/sub>Cl<sub>3<\/sub>N<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, C.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-10511\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-57-300x163.jpg\" alt=\"Econazole Nitrate-1\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-57-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-57-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-57-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-57.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. (1RS)-1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-10512\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-56-300x163.jpg\" alt=\"Econazole Nitrate-2\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-56-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-56-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-56-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-56.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. (2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-10513\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-50-300x163.jpg\" alt=\"Econazole Nitrate-3\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-50-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-50-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-50-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-50.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 1-(4-chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 0665) C18H16Cl3N3O4\u00a0 \u00a0444.7\u00a0 \u00a024169-02-6 Action and use Antifungal. Preparations Econazole Cream Econazole Pessaries DEFINITION 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole nitrate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Very slightly soluble in water, soluble in methanol, sparingly soluble in methylene chloride, slightly soluble in ethanol&#8230;<\/p>\n","protected":false},"author":3,"featured_media":10514,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-10496","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\/10496","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=10496"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10496\/revisions"}],"predecessor-version":[{"id":10518,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10496\/revisions\/10518"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10514"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10496"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}