{"id":22231,"date":"2025-10-29T17:04:43","date_gmt":"2025-10-29T10:04:43","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22231"},"modified":"2025-11-24T11:00:55","modified_gmt":"2025-11-24T04:00:55","slug":"zuclopenthixol-acetate-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/zuclopenthixol-acetate-injection\/","title":{"rendered":"Zuclopenthixol Acetate Injection"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Dopamine receptor antagonist; neuroleptic.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Zuclopenthixol Acetate Injection is a sterile solution of Zuclopenthixol Acetate in a suitable vegetable oil.<\/p>\n<p>The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n<p><strong>Content of zuclopenthixol acetate, C<sub>24<\/sub>H<sub>27<\/sub>ClN<sub>2<\/sub>O<sub>2<\/sub>S<\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, protected from light, using the following solutions.<\/p>\n<p>(1) Dilute a volume of the injection with ethanol (96%) to contain 0.5% w\/v of Zuclopenthixol Acetate.<\/p>\n<p>(2) 0.5% w\/v of zuclopenthixol acetate dihydrochloride BPCRS in ethanol (96%).<\/p>\n<p>(3) 0.5% w\/v each of zuclopenthixol acetate dihydrochloride BPCRS and zuclopenthixol decanoate dihydrochloride BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable).<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 5 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 15 cm.<\/p>\n<p>(e) After removal of the plate, dry in air, spray with a 1% w\/v solution of sodium molybdate in sulfuric acid, heat at 110\u00b0 for 20 minutes and examine in daylight.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>3 volumes of diethylamine and 90 volumes of cyclohexane.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n<p>B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Carry out the method for thin-layer chromatography, Appendix III A, protected from light, using the following solutions.<\/p>\n<p>(1) Dissolve a quantity of the injection containing 0.10 g of Zuclopenthixol Acetate in sufficient dichloromethane to produce 50 mL.<\/p>\n<p>(2) 0.0010% w\/v of 2-chlorothioxanthone BPCRS in dichloromethane.<\/p>\n<p>(3) 0.0020% w\/v of zuclopenthixol hydrochloride BPCRS in dichloromethane containing a few drops of diethylamine.<\/p>\n<p>(4) 0.00040% w\/v of zuclopenthixol hydrochloride BPCRS in dichloromethane containing a few drops of diethylamine.<\/p>\n<p>(5) 0.00020% w\/v of zuclopenthixol hydrochloride BPCRS in dichloromethane containing a few drops of diethylamine.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable).<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 5 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 15 cm.<\/p>\n<p>(e) After removal of the plate, dry in air, spray with a mixture of equal volumes of sulfuric acid and absolute ethanol, heat at 110\u00b0 for 5 minutes and examine under ultraviolet light (365 nm).<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>10 volumes of diethylamine, 40 volumes of dichloromethane and 50 volumes of cyclohexane.<\/p>\n<h4>LIMITS<\/h4>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>any spot corresponding to 2-chlorothioxanthone is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%);<\/p>\n<p>any spot corresponding to zuclopenthixol is not more intense than the spot in the chromatogram obtained with solution (3) (1%);<\/p>\n<p>any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (4) (0.2%);<\/p>\n<p>and not more than one other secondary spot spot is more intense than the spot in the chromatogram obtained with solution (5) (0.1%).<\/p>\n<h3>trans-Isomer<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, protected from light, using the following solutions.<\/p>\n<p>(1) Dissolve a quantity of the injection containing 20 mg of Zuclopenthixol Acetate in 25 mL of dichloromethane and dilute to 50 mL with dichloromethane.<\/p>\n<p>(2) Dissolve 23 mg of trans-clopenthixol acetate dihydrochloride BPCRS (equivalent to 20 mg of trans-clopenthixol acetate) in sufficient dichloromethane containing a few drops of diethylamine to produce 50 mL; dilute 1 mL of the resulting solution to 100 mL with dichloromethane.<\/p>\n<p>(3) Mix equal volumes of solution (1) and undiluted solution (2).<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with silica gel for chromatography (5 \u03bcm) (Spherisorb S 5W is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 254 nm.<\/p>\n<p>(f) Inject 50 \u03bcL of each solution.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>0.08 of a volume of 13.5M ammonia, 45 volumes of dichloromethane, 45 volumes of n-heptane and 50 volumes of acetonitrile.<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the principal peaks is at least 2.6.<\/p>\n<h4>LIMITS<\/h4>\n<p>In the chromatogram obtained with solution (1): the area of any peak corresponding to trans-clopenthixol acetate is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Prepare a 0.2% w\/v solution of cis-flupenthixol propionate dihydrochloride BPCRS (internal standard) in dichloromethane.<\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dissolve a quantity of the injection containing 20 mg of Zuclopenthixol Acetate in 25 mL of dichloromethane, add 5 mL of the internal standard solution and dilute to 50 mL with dichloromethane.<\/p>\n<p>(2) Dissolve 20 mg of zuclopenthixol acetate dihydrochloride BPCRS in 25 mL of dichloromethane containing a few drops of diethylamine, add 5 mL of the internal standard solution and dilute to 50 mL with dichloromethane.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under trans-Isomer may be used.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Determine the weight per mL of the injection, Appendix V G, and calculate the content of C<sub>24<\/sub>H<sub>27<\/sub>ClN<sub>2<\/sub>O<sub>2<\/sub>S using the declared content of C<sub>24<\/sub>H<sub>27<\/sub>ClN<sub>2<\/sub>O<sub>2<\/sub>S in zuclopenthixol acetate dihydrochloride BPCRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Zuclopenthixol Acetate Injection should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION Zuclopenthixol Acetate Injection is a sterile solution of Zuclopenthixol Acetate in a suitable vegetable oil. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of zuclopenthixol acetate, C24H27ClN2O2S 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the&#8230;<\/p>\n","protected":false},"author":4,"featured_media":22239,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22231","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22231","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=22231"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22231\/revisions"}],"predecessor-version":[{"id":22241,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22231\/revisions\/22241"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22239"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22231"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22231"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}