![\"Tiapride](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tiapride-Hydrochloride-2.jpg\")
<\/p>\nBP 2025 (Ph. Eur. 11.6 update)<\/p>\n
<\/p>\n
C15<\/sub>H25ClN2<\/sub>O4<\/sub>S 364.9 51012-33-0<\/p>\n Action and use<\/strong><\/p>\n Dopamine receptor antagonist; neuroleptic.<\/p>\n N-[2-(Diethylamino)ethyl]-2-methoxy-5-(methylsulfonyl)benzamide hydrochloride.<\/p>\n Content<\/strong><\/p>\n 98.5 per cent to 101.0 per cent (dried substance).<\/p>\n Appearance<\/strong><\/p>\n White or almost white, crystalline powder.<\/p>\n Solubility<\/strong><\/p>\n Very soluble in water, soluble in methanol, slightly soluble in anhydrous ethanol.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison tiapride hydrochloride CRS.<\/p>\n B. Solution S (see Tests) 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 50.0 mL with the same solvent.<\/p>\n Appearance of solution<\/strong><\/p>\n Solution S is clear (2.2.1) and its absorbance (2.2.25) at 450 nm is not greater than 0.030.<\/p>\n pH (2.2.3)<\/strong><\/p>\n 4.0 to 6.0 for solution S.<\/p>\n Impurity C<\/strong><\/p>\n Thin-layer chromatography (2.2.27).<\/p>\n Test solution Dissolve 0.400 g of the substance to be examined in methanol R and dilute to 10 mL with the same solvent. Limit:<\/p>\n \u2014 impurity C: any spot due to impurity C is not more intense than the corresponding spot in the chromatogram obtained with the reference solution (0.1 per cent).<\/p>\n Related substances Column: Mobile phase Dissolve 5.44 g of potassium dihydrogen phosphate R and 0.08 g of sodium octanesulfonate R in 780 mL of water R, adjust to pH 2.7 with phosphoric acid R and dilute to 800 mL with water R; add 150 mL of methanol R and 50 mL of acetonitrile R and mix. System suitability Reference solution (b): Calculation of percentage contents: Limits: Loss on drying (2.2.32)<\/strong><\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.300 g in 20 mL of anhydrous acetic acid R. Add 20 mL of acetic anhydride R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n 1 mL of 0.1 M perchloric acid is equivalent to 36.49 mg of C15H25ClN2O4S.<\/p>\n Specified impurities C. BP 2025 (Ph. Eur. 11.6 update) C15H25ClN2O4S 364.9 51012-33-0 Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION N-[2-(Diethylamino)ethyl]-2-methoxy-5-(methylsulfonyl)benzamide hydrochloride. Content 98.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Very soluble in water, soluble in methanol, slightly soluble in anhydrous ethanol. IDENTIFICATION A. Infrared absorption spectrophotometry…<\/p>\n","protected":false},"author":5,"featured_media":32089,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-32075","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\/32075","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=32075"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32075\/revisions"}],"predecessor-version":[{"id":32098,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32075\/revisions\/32098"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/32089"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=32075"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=32075"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=32075"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\nReference solution Dissolve 20.0 mg of metoclopramide impurity E CRS (impurity C) in methanol R and dilute to 50 mL with the same solvent. Dilute 2.0 mL of the solution to 20 mL with methanol R.
\nPlate TLC silica gel F254 plate R.
\nMobile phase concentrated ammonia R, dioxan R, methanol R, methylene chloride R (2:10:14:90 V\/V\/V\/V).
\nApplication 10 \u03bcL.
\nDevelopment Over 4\/5 of the plate.
\nDrying In air.
\nDetection Spray with a 2 g\/L solution of ninhydrin R in butanol R and heat at 100 \u00b0C for 15 min.
\nRetardation factors Impurity C = about 0.1; tiapride = about 0.6.<\/p>\n
\nLiquid chromatography (2.2.29).
\nTest solution Dissolve 0.100 g of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase.
\nReference solution (a) Dilute 1.0 mL of the test solution to 10.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 100.0 mL with the mobile phase.
\nReference solution (b) Dissolve 5.0 mg of tiapride hydrochloride CRS and 5.0 mg of tiapride N-oxide CRS (impurity D) in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n
\n\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;
\n\u2014 stationary phase: base-deactivated end-capped octylsilyl silica gel for chromatography R (5 \u03bcm);
\n\u2014 temperature: 40 \u00b0C.<\/p>\n
\nFlow rate 1.5 mL\/min.
\nDetection Spectrophotometer at 240 nm.
\nInjection 10 \u03bcL.
\nRun time 3 times the retention time of tiapride.
\nIdentification of impurities Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity D.
\nRelative retention With reference to tiapride (retention time = about 7 min): impurity D = about 1.2.<\/p>\n
\n\u2014 resolution: minimum 4.0 between the peaks due to tiapride and impurity D.<\/p>\n
\n\u2014 for each impurity, use the concentration of tiapride hydrochloride in reference solution (a).<\/p>\n
\n\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;
\n\u2014 total: maximum 0.2 per cent;
\n\u2014 reporting threshold: 0.05 per cent.<\/p>\nASSAY<\/h2>\n
IMPURITIES<\/h2>\n
\nOther 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, D.<\/p>\n![\"Tiapride](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tiapride-Hydrochloride-3.jpg\")
\nA. methyl 2-methoxy-5-(methylsulfonyl)benzoate,<\/p>\n![\"Tiapride](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tiapride-Hydrochloride-4.jpg\")
\nB. 2-methoxy-5-(methylsulfonyl)benzoic acid,<\/p>\n![\"Tiapride](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tiapride-Hydrochloride-5.jpg\")
\nC. N,N-diethylethane-1,2-diamine,<\/p>\n![\"Tiapride](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tiapride-Hydrochloride-6.jpg\")
\nD. N-[2-(diethyloxidoaminol)ethyl]-2-methoxy-5-(methylsulfonyl)benzamide (tiapride N-oxide).<\/p>\n","protected":false},"excerpt":{"rendered":"