Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Dopamine receptor antagonist; neuroleptic.<\/p>\n Preparation<\/strong><\/p>\n Zuclopenthixol Decanoate Injection<\/p>\n 2-[4-[3-[(9Z)-2-Chloro-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethyl decanoate.<\/p>\n Content<\/strong><\/p>\n 98.0 per cent to 102.0 per cent (dried substance).<\/p>\n Yellow, viscous, oily liquid.<\/p>\n Very slightly soluble in water, very soluble in ethanol (96 per cent) and in methylene chloride.<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 Ph. Eur. reference spectrum of zuclopenthixol decanoate.<\/p>\n The solution is clear (2.2.1).<\/p>\n Using an ultrasonic bath, dissolve 1.0 g in ethanol (96 per cent) R and dilute to 20.0 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29). Carry out the test protected from light and prepare the solutions immediately before use.<\/p>\n Solution A Dissolve 8.89 g of docusate sodium R in water for chromatography R, stirring for about 6-8 h, and dilute to 1000 mL with the same solvent.<\/p>\n Test solution Dissolve 25.0 mg of the substance to be examined in acetonitrile R and dilute to 100.0 mL with the same solvent.<\/p>\n Reference solution (a)\u00a0 Dilute 1.0 mL of the test solution to 100.0 mL with acetonitrile R.<\/p>\n Reference solution (b) Dissolve 5.0 mg of zuclopenthixol impurity B CRS in acetonitrile R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 100.0 mL with acetonitrile R.<\/p>\n Reference solution (c) Dissolve the contents of a vial of zuclopenthixol for system suitability CRS (containing impurities A, B and C) in 1 mL of methanol R.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m);<\/p>\n \u2014 temperature: 40 \u00b0C.<\/p>\n Mobile phase Mix 25 volumes of solution A and 75 volumes of anhydrous ethanol R, then add 0.1 volumes of phosphoric acid R.<\/p>\n Flow rate\u00a0 1.0 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 270 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n Run time\u00a0 Twice the retention time of zuclopenthixol decanoate.<\/p>\n Identification of impurities Use the chromatogram supplied with zuclopenthixol for system suitability CRS and the chromatograms obtained with reference solutions (b) and (c) to identify the peaks due to impurities A, B and C.<\/p>\n Relative retention With reference to zuclopenthixol decanoate (retention time = about 12 min): impurity C = about 0.4; impurity B = about 0.5; impurity A = about 1.1.<\/p>\n System suitability\u00a0 Reference solution (c):<\/p>\n \u2014 peak-to-valley ratio: minimum 2.0, where Hp = height above the baseline of the peak due to impurity C and<\/p>\n Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity B; and minimum 2.5, where Hp = height above the baseline of the peak due to impurity A and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to zuclopenthixol decanoate.<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than 1.3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.3 per cent);<\/p>\n \u2014 impurity B: not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n \u2014 impurity C: not more than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n \u2014 total: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.5 per cent);<\/p>\n \u2014 disregard limit: 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C for 3 h.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.250 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 27.76 mg of C32<\/sub>H43<\/sub>ClN2<\/sub>O2<\/sub>S.<\/p>\n Under an inert gas in an airtight container, protected from light, at -20 \u00b0C or below.<\/p>\n Specified impurities\u00a0 A, B, C.<\/em><\/p>\n A. 2-[4-[3-[(9E)-2-chloro-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethyl decanoate,<\/p>\n B. 2-chloro-9H-thioxanthen-9-one,<\/p>\n C. 2-[4-[3-[(9Z)-2-chloro-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethanol.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Dopamine receptor antagonist; neuroleptic. Preparation Zuclopenthixol Decanoate Injection DEFINITION 2-[4-[3-[(9Z)-2-Chloro-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethyl decanoate. Content 98.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance Yellow, viscous, oily liquid. Solubility Very slightly soluble in water, very soluble in ethanol (96 per cent) and in methylene chloride. IDENTIFICATION…<\/p>\n","protected":false},"author":5,"featured_media":32035,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-32034","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\/32034","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=32034"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32034\/revisions"}],"predecessor-version":[{"id":32046,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/32034\/revisions\/32046"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/32035"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=32034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=32034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=32034"}],"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
Loss on drying (2.2.32)<\/h3>\n
Sulfated ash (2.4.14)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n