{"id":4976,"date":"2025-09-29T09:23:04","date_gmt":"2025-09-29T02:23:04","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=4976"},"modified":"2025-10-02T23:04:09","modified_gmt":"2025-10-02T16:04:09","slug":"busulfan","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/busulfan\/","title":{"rendered":"Busulfan"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 0542)<\/em><\/p>\n<p>C<sub>6<\/sub>H<sub>14<\/sub>O<sub>6<\/sub>S<sub>2<\/sub>\u00a0 \u00a0 246.3\u00a0 \u00a0 55-98-1<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Cytotoxic alkylating agent.<\/p>\n<p><strong>Preparation<\/strong><\/p>\n<p>Busulfan Tablets<\/p>\n<h2>DEFINITION<\/h2>\n<p>Butane-1,4-diyl di(methanesulfonate).<\/p>\n<h3>Content<\/h3>\n<p>99.0 per cent to 100.5 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Very slightly soluble in water, freely soluble in acetone and in acetonitrile, very slightly soluble in ethanol (96 per cent).<\/p>\n<h3>mp<\/h3>\n<p>About 116 \u00b0C.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>First identification: A.<\/p>\n<p>Second identification: B, C, D.<\/p>\n<p>A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison: busulfan CRS.<\/p>\n<p>B. Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution: Dissolve 20 mg of the substance to be examined in 2 mL of acetone R.<\/p>\n<p>Reference solution: Dissolve 20 mg of busulfan CRS in 2 mL of acetone R.<\/p>\n<p>Plate: TLC silica gel G plate R.<\/p>\n<p>Mobile phase: acetone R, toluene R (50:50 V\/V).<\/p>\n<p>Application: 5 \u03bcL.<\/p>\n<p>Development: Over a path of 15 cm.<\/p>\n<p>Drying: In a current of warm air.<\/p>\n<p>Detection: Spray with anisaldehyde solution R and heat at 120 \u00b0C.<\/p>\n<p>Results: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n<p>C. To 0.1 g add 5 mL of 1 M sodium hydroxide. Heat until a clear solution is obtained. Allow to cool. To 2 mL of the solution add 0.1 mL of potassium permanganate solution R. The colour changes from purple through violet to blue and finally to green. Filter and add 1 mL of ammoniacal silver nitrate solution R. A precipitate is formed.<\/p>\n<p>D. To 0.1 g add 0.1 g of potassium nitrate R and 0.25 g of sodium hydroxide R, mix and heat to fusion. Allow to cool and dissolve the residue in 5 mL of water R. Adjust to pH 1-2 using dilute hydrochloric acid R. The solution gives reaction (a) of sulfates (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is clear (2.2.1) and not more intensely coloured than reference solution B7 (2.2.2, Method II).<br \/>\nDissolve 0.25 g in 20 mL of acetonitrile R, dilute to 25 mL with water R and examine immediately.<\/p>\n<h3>Acidity<\/h3>\n<p>Dissolve 0.20 g with heating in 50 mL of anhydrous ethanol R. Add 0.1 mL of methyl red solution R. Not more than 0.05 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator.<\/p>\n<h3>Loss on drying (2.2.32)<\/h3>\n<p>Maximum 2.0 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C.<\/p>\n<h3>Sulfated ash (2.4.14)<\/h3>\n<p>Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>To 0.250 g add 50 mL of water R. Shake. Boil under a reflux condenser for 30 min and, if necessary, make up to the initial volume with water R. Allow to cool. Using 0.3 mL of phenolphthalein solution R as indicator, titrate with 0.1 M sodium hydroxide until a pink colour is obtained.<\/p>\n<p>1 mL of 0.1 M sodium hydroxide is equivalent to 12.32 mg of C<sub>6<\/sub>H<sub>14<\/sub>O<sub>6<\/sub>S<sub>2<\/sub>.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container, protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 0542) C6H14O6S2\u00a0 \u00a0 246.3\u00a0 \u00a0 55-98-1 Action and use Cytotoxic alkylating agent. Preparation Busulfan Tablets DEFINITION Butane-1,4-diyl di(methanesulfonate). Content 99.0 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Very slightly soluble in water, freely soluble in acetone and in acetonitrile, very slightly soluble&#8230;<\/p>\n","protected":false},"author":4,"featured_media":5001,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-4976","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\/4976","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=4976"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4976\/revisions"}],"predecessor-version":[{"id":5853,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4976\/revisions\/5853"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/5001"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4976"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4976"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}