{"id":22243,"date":"2025-10-29T17:12:52","date_gmt":"2025-10-29T10:12:52","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22243"},"modified":"2025-11-24T11:01:06","modified_gmt":"2025-11-24T04:01:06","slug":"zuclopenthixol-decanoate-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/zuclopenthixol-decanoate-injection\/","title":{"rendered":"Zuclopenthixol Decanoate Injection"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Dopamine receptor antagonist; neuroleptic.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Zuclopenthixol Decanoate Injection is a sterile solution of Zuclopenthixol Decanoate 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 decanoate, C<sub>32<\/sub>H<sub>43<\/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, using the following solutions, protected from light.<\/p>\n<p>(1) Dilute a volume of the injection with ethanol (96%) to contain 0.5% w\/v of Zuclopenthixol Decanoate.<\/p>\n<p>(2) 0.5% w\/v of zuclopenthixol decanoate dihydrochloride BPCRS in ethanol (96%).<\/p>\n<p>(3) 0.5% w\/v each of zuclopenthixol decanoate dihydrochloride BPCRS and zuclopenthixol acetate dihydrochloride BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use as the coating silica gel F254 (Merck silica gel 60 F254 plates are suitable). Before use, heat the plate at 110\u00b0 for 30 minutes.<\/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, allow it to 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 as the mobile phase, using an unlined tank.<\/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 peak due to zuclopenthixol decanoate in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in acetonitrile, protected from light.<\/p>\n<p>(1) Dilute the injection to contain 0.50% w\/v of Zuclopenthixol Decanoate.<\/p>\n<p>(2) 0.015% w\/v of zuclopenthixol hydrochloride BPCRS.<\/p>\n<p>(3) 0.0025% w\/v of 2-chlorothioxanthone BPCRS.<\/p>\n<p>(4) 0.005% w\/v of trans-clopenthixol decanoate dihydrochloride BPCRS.<\/p>\n<p>(5) 0.015% w\/v of zuclopenthixol hydrochloride BPCRS, 0.0025% w\/v of 2-chlorothioxanthone BPCRS and 0.005% w\/v of trans-clopenthixol decanoate dihydrochloride BPCRS in solution (1).<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Waters Symmetry C18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1 mL per minute.<\/p>\n<p>(d) Use a column temperature of 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) For solution (1), allow the chromatography to proceed for twice retention time of the principal peak.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>0.1 volume of orthophosphoric acid, 26 volumes of 0.02M dioctyl sodium sulfosuccinate (prepared by dissolving 8.89 g of dioctyl sodium sulfosuccinate in 500 mL of water, stirring for 6 to 8 hours and diluting to 1000 mL with water) and 74 volumes of ethanol (96%).<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless the chromatogram obtained with solution (5) shows clearly separated peaks.<\/p>\n<h4>LIMITS<\/h4>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to zuclopenthixol is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (3%);<\/p>\n<p>the area of any peak corresponding to 2-chlorothioxanthone is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n<p>the area of any peak corresponding to trans-clopenthixol decanoate is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions solutions in acetonitrile protected from light.<\/p>\n<p>(1) Dilute a volume of the injection to contain 0.50% w\/v of Zuclopenthixol Decanoate.<\/p>\n<p>(2) 0.57% w\/v of zuclopenthixol decanoate dihydrochloride BPCRS.<\/p>\n<p>(3) 0.015% w\/v of zuclopenthixol hydrochloride BPCRS, 0.0025% w\/v of 2-chlorothioxanthone BPCRS and 0.005% w\/v of trans-clopenthixol decanoate dihydrochloride BPCRS in solution (1).<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Related substances may be used.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows clearly separated peaks.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>32<\/sub>H<sub>43<\/sub>ClN<sub>2<\/sub>O<sub>2<\/sub>S using the declared content of C<sub>32<\/sub>H<sub>43<\/sub>ClN<sub>2<\/sub>O<sub>2<\/sub>S in zuclopenthixol decanoate dihydrochloride BPCRS. Each mg of zuclopenthixol decanoate dihydrochloride is equivalent to 0.8852 mg of zuclopenthixol decanoate.<\/p>\n<h2>STORAGE<\/h2>\n<p>Zuclopenthixol Decanoate Injection should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION Zuclopenthixol Decanoate Injection is a sterile solution of Zuclopenthixol Decanoate in a suitable vegetable oil. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of zuclopenthixol decanoate, C32H43ClN2O2S 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the&#8230;<\/p>\n","protected":false},"author":4,"featured_media":22249,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22243","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\/22243","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=22243"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22243\/revisions"}],"predecessor-version":[{"id":22253,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22243\/revisions\/22253"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22249"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22243"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22243"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22243"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}