Edition: BP 2025 (Ph. Eur. 11.6 update)
\n(Ph. Eur. monograph 1123)<\/p>\n
Action and use<\/strong><\/p>\n Non-ionic surfactant.<\/p>\n Mixture of ethers of mixed macrogols with linear fatty alcohols, mainly cetostearyl alcohol. It may contain some free macrogols and it contains various amounts of free cetostearyl alcohol. The number of moles of ethylene oxide reacted per mole of cetostearyl alcohol is 2 to 33 (nominal value).<\/p>\n Appearance<\/strong> Solubility<\/strong><\/p>\n Macrogol cetostearyl ether with low numbers of moles of ethylene oxide reacted per mole: practically insoluble in water, soluble in ethanol (96 per cent) and in methylene chloride;<\/p>\n Macrogol cetostearyl ether with higher numbers of moles of ethylene oxide reacted per mole: dispersible or soluble in water, soluble in ethanol (96 per cent) and in methylene chloride.<\/p>\n It solidifies at 32\u202f\u00b0C to 52\u202f\u00b0C.<\/p>\n A. Hydroxyl value (see Tests). Test solution: Dissolve the prescribed amount of substance to be examined (see table below) in a mixture of 1 volume of water R and 9 volumes of methanol R and dilute to 75 mL with the same mixture of solvents.<\/p>\n Add 60 mL of hexane R and shake for 3 min. The formation of foam can be reduced by the addition of some drops of ethanol (96 per cent) R. Filter the upper layer through anhydrous sodium sulfate R, wash the filter with 3 quantities, each of 10 mL, of hexane R and evaporate the combined filtrates to dryness. Dissolve 0.05 g of the residue in 10 mL of methanol R (the solution may be opalescent).<\/p>\n Reference solution: Dissolve 25 mg of stearyl alcohol CRS in methanol R and dilute to 25 mL with the same solvent.<\/p>\n Plate: TLC silica gel plate R.<\/p>\n Mobile phase: ethyl acetate R.<\/p>\n Application: 20 \u00b5L.<\/p>\n Development: Over a path of 15 cm.<\/p>\n Drying: In air.<\/p>\n Detection: Spray with vanillin-sulfuric acid reagent prepared as follows: dissolve 0.5 g of vanillin R in 50 mL of ethanol (96 per cent) R and dilute to 100 mL with sulfuric acid R; allow to dry in air; heat at about 130 \u00b0C for 15 min and allow to cool in air.<\/p>\n Results: The chromatogram obtained with the test solution shows several spots; one of these spots corresponds to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n E. Dissolve or disperse 0.1 g in 5 mL of ethanol (96 per cent) R, add 2 mL of water R, 10 mL of dilute hydrochloric acid R, 10 mL of barium chloride solution R1 and 10 mL of a 100 g\/L solution of phosphomolybdic acid R. A precipitate is formed.<\/p>\n Appearance of solution<\/strong> Alkalinity<\/strong> Acid value (2.5.1)<\/strong> Hydroxyl value (2.5.3, Method A)<\/p>\n Iodine value (2.5.4, Method A)<\/strong> Saponification value (2.5.6)<\/strong> Ethylene oxide and dioxan (2.4.25)<\/strong> Water (2.5.12) Total ash (2.4.16) In an airtight container.<\/p>\n The label states the number of moles of ethylene oxide reacted per mole of cetostearyl alcohol (nominal value).<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1123) Action and use Non-ionic surfactant. DEFINITION Mixture of ethers of mixed macrogols with linear fatty alcohols, mainly cetostearyl alcohol. It may contain some free macrogols and it contains various amounts of free cetostearyl alcohol. The number of moles of ethylene oxide reacted per mole…<\/p>\n","protected":false},"author":5,"featured_media":23200,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-23197","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\/23197","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=23197"}],"version-history":[{"count":1,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23197\/revisions"}],"predecessor-version":[{"id":23209,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23197\/revisions\/23209"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23200"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23197"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23197"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
\nWhite or yellowish-white, waxy, unctuous mass, pellets, microbeads or flakes.<\/p>\nIDENTIFICATION<\/h2>\n
\nB. Iodine value (see Tests).
\nC. Saponification value (see Tests).
\nD. Thin-layer chromatography (2.2.27).<\/p>\n\n\n
\n \nNumber of moles of ethylene oxide reacted per mole<\/th>\n Amount to be dissolved (g)<\/th>\n<\/tr>\n<\/thead>\n \n 2 \u2013 6<\/td>\n 5.0<\/td>\n<\/tr>\n \n 10 \u2013 22<\/td>\n 10.0<\/td>\n<\/tr>\n \n 25 \u2013 33<\/td>\n 15.0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n TESTS<\/h2>\n
\nThe solution is not more intensely coloured than reference solution BY5 (2.2.2, Method II).
\nDissolve 5.0 g in ethanol (96 per cent) R and dilute to 50 mL with the same solvent.<\/p>\n
\nDissolve 2.0 g in a hot mixture of 10 mL of ethanol (96 per cent) R and 10 mL of water R. Add 0.1 mL of bromothymol blue solution R1. Not more than 0.5 mL of 0.1 M hydrochloric acid is required to change the colour of the indicator to yellow.<\/p>\n
\nMaximum 1.0, determined on 5.0 g.<\/p>\n\n\n
\n \nNumber of moles of ethylene oxide reacted per mole (nominal value)<\/th>\n Hydroxyl value<\/th>\n<\/tr>\n<\/thead>\n \n 2<\/td>\n 150 \u2013 180<\/td>\n<\/tr>\n \n 3<\/td>\n 135 \u2013 155<\/td>\n<\/tr>\n \n 5\u20136<\/td>\n 100 \u2013 134<\/td>\n<\/tr>\n \n 10<\/td>\n 75 \u2013 90<\/td>\n<\/tr>\n \n 12<\/td>\n 67 \u2013 77<\/td>\n<\/tr>\n \n 15<\/td>\n 58 \u2013 67<\/td>\n<\/tr>\n \n 20\u201322<\/td>\n 40 \u2013 55<\/td>\n<\/tr>\n \n 25<\/td>\n 36 \u2013 46<\/td>\n<\/tr>\n \n 30\u201333<\/td>\n 32 \u2013 40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nMaximum 2.0.<\/p>\n
\nMaximum 3.0, determined on 10.0 g.<\/p>\n
\nMaximum 1 ppm of ethylene oxide and maximum 10 ppm of dioxan.<\/p>\n
\nMaximum 3.0 per cent, determined on 2.00 g.<\/p>\n
\nMaximum 0.2 per cent, determined on 2.0 g.<\/p>\nSTORAGE<\/h2>\n
LABELLING<\/h2>\n