{"id":21323,"date":"2025-10-28T13:21:10","date_gmt":"2025-10-28T06:21:10","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21323"},"modified":"2025-10-28T13:21:10","modified_gmt":"2025-10-28T06:21:10","slug":"macrogol-15-hydroxystearate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/macrogol-15-hydroxystearate\/","title":{"rendered":"Macrogol 15 Hydroxystearate"},"content":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Non-ionic surfactant.<\/p>\n<p>Ph Eur<\/p>\n<h2>DEFINITION<\/h2>\n<p>Mixture of mainly monoesters and diesters of 12-hydroxystearic ((12\u2261)-hydroxyoctadecanoic) acid and macrogols obtained by ethoxylation of 12-hydroxystearic acid. The number of moles of ethylene oxide reacted per mole of 12-hydroxystearic acid is 15 (nominal value). It contains free macrogols.<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>Yellowish, waxy mass.<\/p>\n<h3>Solubility<\/h3>\n<p>Very soluble in water, soluble in ethanol (96 per cent), insoluble in liquid paraffin.<\/p>\n<p>It solidifies at about 25\u00b0C.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution To 1.0 g add 100 mL of a 100 g\/L solution of potassium hydroxide R and boil under a reflux condenser for 30 min. Acidify the warm solution with 20 mL of hydrochloric acid R and cool to room temperature. Shake the mixture with 50 mL of ether R and allow to stand until a separation of the layers is visible. Separate the clear upper layer, add 5 g of anhydrous sodium sulfate R, wait for 30 min, filter and evaporate to dryness on a water-bath. Dissolve 50 mg of the residue in 25 mL of ether R.<\/p>\n<p>Reference solution Dissolve 50 mg of 12-hydroxystearic acid R in 25 mL of methylene chloride R.<\/p>\n<p>Plate TLC octadecylsilyl silica gel plate R.<\/p>\n<p>Mobile phase methylene chloride R, glacial acetic acid R, acetone R (10:40:50 V\/V\/V).<\/p>\n<p>Application 2 \u03bcL.<\/p>\n<p>Development Over 2\/3 of the plate.<\/p>\n<p>Drying In a current of cold air.<\/p>\n<p>Detection Spray with a 80 g\/L solution of phosphomolybdic acid R in 2-propanol R and heat at 120\u00b0C for 1-2 min.<\/p>\n<p>Results The principal spot in the chromatogram obtained with the test solution is similar in position and colour to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n<p>B. Dissolve 15.0 g in 50 mL of water R. The viscosity (2.2.9) has a maximum of 20 mPa-s.<\/p>\n<p>C. Free macrogols (see Tests).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is not more opalescent than reference suspension III (2.2.1) and not more intensely coloured than reference solution B<sub>6<\/sub> or BY<sub>6<\/sub> (2.2.2, Method II).<\/p>\n<p>Dissolve 2.0 g in water R and dilute to 20 mL with the same solvent.<\/p>\n<h4>Acid value (2.5.1)<\/h4>\n<p>Maximum 1.0, determined on 2.0 g.<\/p>\n<h4>Hydroxyl value (2.5.3, Method A)<\/h4>\n<p>90 to 110.<\/p>\n<h4>Iodine value (2.5.4, Method A)<\/h4>\n<p>Maximum 2.0.<\/p>\n<h4>Peroxide value (2.5.5, Method A)<\/h4>\n<p>Maximum 5.0.<\/p>\n<h4>Saponification value (2.5.6)<\/h4>\n<p>53 to 63.<\/p>\n<h3>Free macrogols<\/h3>\n<p>Size-exclusion chromatography (2.2.30).<\/p>\n<p>Test solution Dissolve 1.20 g of the substance to be examined in the mobile phase and dilute to 250.0 mL with the mobile phase.<\/p>\n<p>Reference solution (a) Dissolve about 0.4 g of macrogol 1000 R in the mobile phase and dilute to 250.0 mL with the mobile phase.<\/p>\n<p>Reference solution (b) Dilute 50.0 mL of reference solution (a) to 100.0 mL with the mobile phase.<\/p>\n<p>Precolumns (2):<\/p>\n<ul>\n<li>size: l = 0.125 m, \u00d8 = 4 mm;<\/li>\n<li>stationary phase: spherical octadecylsilyl silica gel for chromatography R (5 \u03bcm) with a pore size of 10 nm.<\/li>\n<\/ul>\n<p>Column:<\/p>\n<ul>\n<li>size: l = 0.30 m, \u00d8 = 7.8 mm;<\/li>\n<li>stationary phase: hydroxylated polymethacrylate gel R (6 \u03bcm) with a pore size of 12 nm.<\/li>\n<\/ul>\n<p>Connect both precolumns to the column using a 3-way valve and switch the mobile phase flow according to the following programme:<\/p>\n<ul>\n<li>0-114 s: precolumn 1 and column;<\/li>\n<li>115 s to the end: precolumn 2 and column;<\/li>\n<li>115 s to 7 min: flow back of precolumn 1.<\/li>\n<\/ul>\n<p>Mobile phase water for chromatography R, methanol R (20:80 V\/V).<\/p>\n<p>Flow rate 1.1 mL\/min.<\/p>\n<p>Detection Refractometer.<\/p>\n<p>Injection 50 \u03bcL.<\/p>\n<p>Calculate the percentage content of free macrogols using the following expression:<\/p>\n<p><a href=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-British-Pharmacopoeia.pdf\">Macrogol 15 Hydroxystearate &#8211; British Pharmacopoeia<\/a><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-21326\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-1.jpg\" alt=\"\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-1.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Macrogol-15-Hydroxystearate-1-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p>m1 = mass of the substance to be examined in the test solution, in grams;<\/p>\n<p>m<sub>2 <\/sub>= mass of macrogol 1000 R in reference solution (a), in grams;<\/p>\n<p>A1 = area of the peak due to free macrogols in the substance to be examined in the\u00a0chromatogram obtained with the test solution;<\/p>\n<p>A<sub>2<\/sub> = area of the peak due to macrogol 1000 in the chromatogram obtained with reference solution (a);<\/p>\n<p>A3 = area of the peak due to macrogol 1000 in the chromatogram obtained with reference solution (b).<\/p>\n<p>Limit:<\/p>\n<p>\u2014 free macrogols: 27.0 per cent to 39.0 per cent.<\/p>\n<h4>Ethylene oxide and dioxan (2.4.25)<\/h4>\n<p>Maximum 1 ppm of ethylene oxide and maximum 50 ppm of dioxan.<\/p>\n<h4>Water (2.5.12)<\/h4>\n<p>Maximum 1.0 per cent, determined on 2.00 g.<\/p>\n<h4>Total ash (2.4.16)<\/h4>\n<p>Maximum 0.3 per cent, determined on 1.0 g.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container.<\/p>\n<p>Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update) Action and use Non-ionic surfactant. Ph Eur DEFINITION Mixture of mainly monoesters and diesters of 12-hydroxystearic ((12\u2261)-hydroxyoctadecanoic) acid and macrogols obtained by ethoxylation of 12-hydroxystearic acid. The number of moles of ethylene oxide reacted per mole of 12-hydroxystearic acid is 15 (nominal value). It contains free macrogols. CHARACTERS Appearance&#8230;<\/p>\n","protected":false},"author":5,"featured_media":21325,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-21323","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\/21323","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=21323"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21323\/revisions"}],"predecessor-version":[{"id":21328,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21323\/revisions\/21328"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21325"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21323"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21323"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21323"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}