Alpha2<\/sub>-adrenoceptor agonist.<\/p>\n 4-[(2,3-Dimethylphenyl)methyl]-1H-imidazole hydrochloride.<\/p>\n Content<\/p>\n 99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n White or almost white, hygroscopic, crystalline powder.<\/p>\n Soluble in water, freely soluble in ethanol (96 per cent), very slightly soluble in methylene chloride.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 detomidine hydrochloride CRS.<\/p>\n If the spectra obtained show differences, dry the substance to be examined and the reference substance separately in an oven at 105 \u00b0C and record new spectra.<\/p>\n B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n The solution is clear (2.2.1) and colourless (2.2.2, Method II). Dissolve 0.25 g in water R and dilute to 25 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution Dissolve 25 mg of the substance to be examined in 20 mL of the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n Reference solution (a)\u00a0 Dilute 0.20 mL of the test solution to 100.0 mL with the mobile phase.<\/p>\n Reference solution (b) Dissolve 1 mg of detomidine impurity B CRS in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 10.0 mL with reference solution (a).<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped octylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n Mobile phase acetonitrile R1, 2.64 g\/L solution of ammonium phosphate R (35:65 V\/V). Flow rate 1 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 220 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n Run time\u00a0 4 times the retention time of detomidine.<\/p>\n Identification of impurities Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity B.<\/p>\n Relative retention\u00a0 With reference to detomidine (retention time = about 6 min): impurity B = about 2.1.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 resolution: minimum 5.0 between the peaks due to detomidine and impurity B.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of detomidine hydrochloride in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.20 per cent;<\/p>\n \u2014 total: maximum 0.5 per cent;<\/p>\n \u2014 reporting threshold: 0.10 per cent.<\/p>\n Maximum 2.0 per cent, determined on 0.250 g.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.170 g in 50 mL of ethanol (96 per cent) R. Add 5.0 mL of 0.01 M hydrochloric acid. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 22.27 mg of C12<\/sub>H15<\/sub>ClN2<\/sub>.<\/p>\n In an airtight container.<\/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 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, B, C.<\/em><\/p>\n A. (RS)-(2,3-dimethylphenyl)(1H-imidazol-4-yl)methanol,<\/p>\n B. (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol,<\/p>\n C. 4-[(2,3-dimethylcyclohexyl)methyl]-1H-imidazole.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Alpha2-adrenoceptor agonist. DEFINITION 4-[(2,3-Dimethylphenyl)methyl]-1H-imidazole hydrochloride. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, hygroscopic, crystalline powder. Solubility Soluble in water, freely soluble in ethanol (96 per cent), very slightly soluble in methylene chloride. IDENTIFICATION A. Infrared absorption…<\/p>\n","protected":false},"author":5,"featured_media":23400,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-23399","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23399","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=23399"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23399\/revisions"}],"predecessor-version":[{"id":23457,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23399\/revisions\/23457"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23400"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23399"}],"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
Appearance of solution<\/h3>\n
Related substances<\/h3>\n
Water (2.5.12)<\/h2>\n
Sulfated ash (2.4.14)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Detomidine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Detomidine-Hydrochloride-British-Pharmacopoeia-2025-1.jpg\")
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<\/p>\n