Action and use<\/strong><\/p>\n Antifungal.<\/p>\n 1-[4-[[(2RS,4SR)-2-(2,4-Dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]-4-(1-methylethyl)piperazine.<\/p>\n Content<\/strong><\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white powder.<\/p>\n Practically insoluble in water, freely soluble in methylene chloride, soluble in acetone, sparingly soluble in ethanol (96 per cent).<\/p>\n It shows polymorphism (5.9).<\/p>\n First identification: A.<\/p>\n Second identification: B, C.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison<\/em>\u00a0 \u00a0terconazole CRS.<\/p>\n If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in the minimum volume of acetone R, evaporate to dryness in a current of air and record new spectra using the residues.<\/p>\n B. Thin-layer chromatography (2.2.27).<\/p>\n Test solution<\/em>\u00a0 \u00a0Dissolve 30 mg of the substance to be examined in methanol R and dilute to 5 mL with the same solvent.<\/p>\n Reference solution (a)<\/em>\u00a0 \u00a0Dissolve 30 mg of terconazole CRS in methanol R and dilute to 5 mL with the same solvent.<\/p>\n Reference solution (b)<\/em>\u00a0 \u00a0Dissolve 30 mg of ketoconazole CRS and 30 mg of terconazole CRS in methanol R and dilute to 5 mL with the same solvent.<\/p>\n Plate\u00a0 \u00a0<\/em>TLC octadecylsilyl silica gel plate R.<\/p>\n Mobile phase<\/em>\u00a0 \u00a0ammonium acetate solution R, dioxan R, methanol R (20:40:40 V\/V\/V).<\/p>\n Application\u00a0 \u00a0<\/em>5 \u03bcL.<\/p>\n Development\u00a0 \u00a0<\/em>In an unsaturated tank over half of the plate.<\/p>\n Drying\u00a0 \u00a0<\/em>In a current of warm air for 15 min.<\/p>\n Detection<\/em>\u00a0 \u00a0Expose to iodine vapour until the spots appear and examine in daylight.<\/p>\n System suitability<\/em>\u00a0 \u00a0Reference solution (b):<\/p>\n \u2014 the chromatogram shows 2 clearly separated spots.<\/p>\n Results<\/em>\u00a0 \u00a0The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).<\/p>\n C. To 30 mg in a porcelain crucible add 0.3 g of anhydrous sodium carbonate R. Heat over an open flame for 10 min. Allow to cool. Take up the residue with 5 mL of dilute nitric acid R and filter. To 1 mL of the filtrate add 1 mL of water R. The solution gives reaction (a) of chlorides (2.3.1).<\/p>\n -0.10\u00b0 to + 0.10\u00b0.<\/p>\n Dissolve 1.0 g in methylene chloride R and dilute to 10 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution<\/em>\u00a0 \u00a0Dissolve 0.100 g of the substance to be examined in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n Reference solution (a)<\/em>\u00a0 \u00a0Dissolve 2.0 mg of ketoconazole CRS and 2.5 mg of terconazole CRS in methanol R and dilute to 100.0 mL with the same solvent.<\/p>\n Reference solution (b)<\/em>\u00a0 \u00a0Dilute 1.0 mL of the test solution to 100.0 mL with methanol R. Dilute 5.0 mL of this solution to 20.0 mL with methanol R.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.1 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: base-deactivated octadecylsilyl silica gel for chromatography R (3 \u03bcm).<\/p>\n Mobile phase:<\/p>\n \u2014 mobile phase A: 3.4 g\/L solution of tetrabutylammonium hydrogen sulfate R;<\/p>\n \u2014 mobile phase B: acetonitrile R1;<\/p>\n Flow rate<\/em>\u00a0 \u00a02 mL\/min.<\/p>\n Detection<\/em>\u00a0 \u00a0Spectrophotometer at 220 nm.<\/p>\n Injection<\/em>\u00a0 \u00a010 \u03bcL.<\/p>\n Relative retention<\/em>\u00a0 \u00a0With reference to terconazole (retention time = about 7.5 min): ketoconazole = about 0.8; impurity A = about 0.85; impurity B = about 0.9.<\/p>\n System suitability<\/em>\u00a0 \u00a0Reference solution (a):<\/p>\n \u2014 resolution: minimum 13 between the peaks due to ketoconazole and terconazole.<\/p>\n Limits:<\/p>\n \u2014 impurities A, B: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.25 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.4 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n \u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n \u2014 disregard limit: 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.150 g in 70 mL of a mixture of 1 volume of anhydrous acetic acid R and 7 volumes of methyl ethyl ketone R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically at the 2 point of inflexion (2.2.20).<\/p>\n 1 mL of 0.1 M perchloric acid is equivalent to 17.75 mg of C26<\/sub>H31<\/sub>Cl2<\/sub>N5<\/sub>O3<\/sub>.<\/p>\n Protected from light.<\/p>\n Specified impurities A, B.<\/p>\n (Ph. Eur. monograph 1270) C26H31Cl2N5O3 532.5 67915-31-5 Action and use Antifungal. DEFINITION 1-[4-[[(2RS,4SR)-2-(2,4-Dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]-4-(1-methylethyl)piperazine. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Practically insoluble in water, freely soluble in methylene chloride, soluble in acetone, sparingly soluble in ethanol (96 per cent). It shows polymorphism (5.9). IDENTIFICATION…<\/p>\n","protected":false},"author":5,"featured_media":29551,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29505","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\/29505","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=29505"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29505\/revisions"}],"predecessor-version":[{"id":29571,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29505\/revisions\/29571"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29551"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29505"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29505"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29505"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Optical rotation (2.2.7)<\/h3>\n
Related substances<\/h3>\n
\n\n
\n Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n \n 0 – 10<\/td>\n 95 \u2192 50<\/td>\n 5 \u2192 50<\/td>\n<\/tr>\n \n 10 – 15<\/td>\n 50<\/td>\n 50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Loss on drying (2.2.32)<\/h3>\n
Sulfated ash (2.4.14)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Terconazole\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/terconazole-1.jpg\")
\nA. 1-[4-[[(2RS,4RS)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]-4-(1-methylethyl)piperazine,<\/p>\n![\"Terconazole\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/terconazole-2.jpg\")
\nB. 1-[4-[[(2RS,4SR)-2-(2,4-dichlorophenyl)-2-[(4H-1,2,4-triazol-4-yl)methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]-4-(1-methylethyl)piperazine.<\/p>\n","protected":false},"excerpt":{"rendered":"