Action and use<\/strong><\/p>\n Histamine H1, receptor antagonist; sedative.<\/p>\n Preparations<\/strong><\/p>\n Paediatric Alimemazine Oral Solution<\/p>\n Strong Paediatric Alimemazine Oral Solution<\/p>\n Alimemazine Tablets<\/p>\n (2RS)-N,N,2-Trimethyl-3-(10H-phenothiazin-10-yl)propan-1-amine hemi[(2R,3R)-2,3-dihydroxybutanedioate].<\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n White or very slightly yellowish powder.<\/p>\n Freely soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in toluene.<\/p>\n It deteriorates when exposed to air and light.<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison alimemazine hemitartrate CRS.<\/p>\n The solution is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution BY5<\/sub> (2.2.2, Method II).<\/p>\n Dissolve 1.0 g in water R and dilute to 10 mL with the same solvent.<\/p>\n 5.0 to 6.5. Carry out the test protected from light and use a freshly prepared solution.<\/p>\n Dissolve 1.0 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29). Carry out the test protected from light and use freshly prepared solutions.<\/p>\n Solvent mixture: acetonitrile R, water R (20:80 V\/V).<\/p>\n Test solution: Dissolve 35 mg of the substance to be examined in the solvent mixture and dilute to 100.0 mL with the solvent mixture.<\/p>\n Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n Reference solution (b): Dissolve 3.5 mg of alimemazine for system suitability CRS (containing impurities A, B and C) in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (3 \u03bcm);<\/p>\n \u2014 temperature: 40 \u00b0C.<\/p>\n Mobile phase: acetonitrile R, methanol R, 3.854 g\/L solution of ammonium acetate R (10:40:50 V\/V\/V).<\/p>\n Flow rate: 1.3 mL\/min.<\/p>\n Detection: Spectrophotometer at 253 nm.<\/p>\n Injection: 20 \u03bcL.<\/p>\n Run time: Twice the retention time of alimemazine.<\/p>\n Identification of impurities: Use the chromatogram supplied with alimemazine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B and C.<\/p>\n Relative retention: With reference to alimemazine (retention time = about 27 min): impurity A = about 0.1; impurity B = about 0.5; impurity C = about 1.4.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 5.0 between the peaks due to alimemazine and impurity C.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factors: multiply the peak areas of the following impurities by the corresponding correction factor:<\/p>\n impurity A = 4.4; impurity C = 0.4;<\/p>\n \u2014 for each impurity, use the concentration of alimemazine hemitartrate in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 impurity B: maximum 0.3 per cent;<\/p>\n \u2014 impurities A, C: for each impurity, maximum 0.15 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.300 g in 50 mL of anhydrous acetic acid 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 37.35 mg of C20H25N2O3S.<\/p>\n In an airtight container, protected from light.<\/p>\n Specified impurities A, B, C.<\/p>\n A. (2RS)-N,N,2-trimethyl-3-(5-oxido-10H-phenothiazin-10-yl)propan-1-amine,<\/p>\n B. (2RS)-N,2-dimethyl-3-(10H-phenothiazin-10-yl)propan-1-amine,<\/p>\n C. 10H-phenothiazine.<\/p>\n","protected":false},"excerpt":{"rendered":" (Alimemazine Hemitartrate Ph. Eur. monograph 2650) C20H25N2O3S\u00a0 \u00a0 \u00a0 373.5\u00a0 \u00a0 \u00a0 \u00a04330-99-8 Action and use Histamine H1, receptor antagonist; sedative. Preparations Paediatric Alimemazine Oral Solution Strong Paediatric Alimemazine Oral Solution Alimemazine Tablets DEFINITION (2RS)-N,N,2-Trimethyl-3-(10H-phenothiazin-10-yl)propan-1-amine hemi[(2R,3R)-2,3-dihydroxybutanedioate]. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or very slightly yellowish powder. Solubility…<\/p>\n","protected":false},"author":2,"featured_media":1445,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-1429","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\/1429","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=1429"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/1429\/revisions"}],"predecessor-version":[{"id":6931,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/1429\/revisions\/6931"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/1445"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=1429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=1429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=1429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Appearance of solution<\/h3>\n
pH (2.2.3)<\/h4>\n
Related substances<\/h3>\n
Loss on drying (2.2.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Alimemazine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Alimemazine-Tartrate-A-2-300x163.jpg\")
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