Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
(Ph. Eur. monograph 1124)<\/p>\n
Action and use<\/strong><\/p>\n Non-ionic surfactant.<\/p>\n Ph Eur<\/p>\n Mixture of ethers of mixed macrogols with linear fatty alcohols, mainly C12<\/sub>H26<\/sub>O. It contains a variable quantity of free C12<\/sub>H26<\/sub>O and may contain free macrogols. The number of moles of ethylene oxide reacted per mole of C12<\/sub>H26<\/sub>O is 3 to 23 (nominal value).<\/p>\n \u2014 Macrogol lauryl ethers with 3 to 5 units of ethylene oxide per molecule.<\/p>\n Appearance<\/strong><\/p>\n Colourless liquid.<\/p>\n Solubility<\/strong><\/p>\n Practically insoluble in water, soluble or dispersible in ethanol (96 per cent), practically insoluble in light petroleum.<\/p>\n \u2014 Macrogol lauryl ethers with 9 units of ethylene oxide per molecule.<\/p>\n Appearance<\/strong><\/p>\n White or almost white, unctuous, hygroscopic mass, melting at 24 \u00b0C into a colourless or yellowish, viscous liquid.<\/p>\n Solubility<\/strong><\/p>\n Freely soluble in water, soluble or dispersible in ethanol (96 per cent), practically insoluble in light petroleum.<\/p>\n \u2014 Macrogol lauryl ethers with 10 to 23 units of ethylene oxide per molecule.<\/p>\n Appearance<\/strong><\/p>\n White or almost white, waxy mass.<\/p>\n Solubility<\/strong><\/p>\n Soluble or dispersible in water, soluble in ethanol (96 per cent), practically insoluble in light petroleum.<\/p>\n Carry out tests A, B, C, D, E for macrogol lauryl ethers with 3 to 5 units of ethylene oxide per molecule.<\/p>\n Carry out tests A, B, C, D, F for macrogol lauryl ethers with 9 to 23 units of ethylene oxide per molecule.<\/p>\n A. Hydroxyl value (see Tests). Test solution Dissolve 0.200 g of the substance to be examined in acetone R and dilute to 10.0 mL with the same solvent.<\/p>\n Reference solution Dissolve 0.15 g of ethylene glycol monododecyl ether R, 0.15 g of lauryl alcohol R and 0.15 g of myristyl alcohol R in acetone R and dilute to 100.0 mL with the same solvent.<\/p>\n Column:<\/p>\n \u2014 material: fused silica;<\/p>\n \u2014 size: l = 30 m, \u00d8 = 0.25 mm;<\/p>\n \u2014 stationary phase: phenyl(5)methyl(95)polysiloxane R (film thickness 0.25 \u03bcm).<\/p>\n Carrier gas helium for chromatography R or hydrogen for chromatography R.<\/p>\n Flow rate 1 mL\/min.<\/p>\n Split ratio 1:50.<\/p>\n Temperature:<\/p>\n 1 – 24<\/p>\n 24 – 34<\/td>\n 120 \u2192 350<\/p>\n 350<\/td>\n<\/tr>\n Detection Flame ionisation.<\/p>\n Injection 1.0 \u03bcL.<\/p>\n Identification of peaks Use the chromatogram obtained with the reference solution to identify the peaks due to ethylene glycol monododecyl ether, lauryl alcohol and myristyl alcohol.<\/p>\n Retention time Lauryl alcohol = about 6.7 min; myristyl alcohol = about 8.9 min; ethylene glycol monododecyl ether = about 9.3 min.<\/p>\n System suitability Reference solution:<\/p>\n \u2014 resolution: minimum 5.0 between the peaks due to myristyl alcohol and ethylene glycol monododecyl ether.<\/p>\n Results The sum of the areas of the peaks eluted before the peak due to lauryl alcohol is less than 10 per cent of the area of the peak due to lauryl alcohol; disregard the peak due to the solvent.<\/p>\n F. Gas chromatography (2.2.28).<\/p>\n Test solution Into a 50 mL round-bottomed flask fitted with a reflux condenser introduce 0.300 g of the substance to be examined, 15 mL of hydriodic acid R, 2.5 mL of a 603 g\/L solution of phosphorous acid R and 2 or 3 anti-bumping granules. Heat to 140 \u00b0C using an oil bath or an electric heating mantle, then boil for 2 h. Allow to cool to room temperature and rinse the condenser with 5 mL of ethanol (96 per cent) R. Add the rinsings to the flask and transfer to a separating funnel, rinsing the flask with 2 quantities, each of 5 mL, of a mixture of equal volumes of ethanol (96 per cent) R and water R.<\/p>\n Extract with 15 mL of heptane R and wash the upper layer with 5 mL portions of a mixture of equal volumes of ethanol (96 per cent) R and water R until the pH of the lower layer is greater than 3 using a pH indicator strip R.<\/p>\n Transfer the upper layer into a 20 mL glass vial with a screw cap and shake with 5 g of anhydrous sodium sulfate R. Allow to settle and transfer about 1 mL of the clear supernatant to an autosampler vial.<\/p>\n Reference solution Prepare as described for the test solution using 0.150 g of 2-butyloctanol R, 0.150 g of lauryl alcohol R and 0.150 g of myristyl alcohol R instead of the substance to be examined.<\/p>\n Column:<\/p>\n \u2014 material: fused silica;<\/p>\n \u2014 size: l = 30 m, \u00d8 = 0.32 mm;<\/p>\n \u2014 stationary phase: phenyl(5)methyl(95)polysiloxane R (film thickness 1.0 \u03bcm).<\/p>\n Carrier gas helium for chromatography R or hydrogen for chromatography R.<\/p>\n Flow rate 3 mL\/min.<\/p>\n Split ratio 1:30.<\/p>\n Temperature:<\/p>\n 5 – 55<\/p>\n 55 – 70<\/td>\n 100 \u2192 300<\/p>\n 300<\/td>\n<\/tr>\n Detection Flame ionisation.<\/p>\n Injection 1.0 \u03bcL.<\/p>\n Identification of peaks Use the chromatogram obtained with the reference solution to identify the peaks due to 2-butyloctyl iodide, lauryl iodide and myristyl iodide.<\/p>\n Retention time 2-butyloctyl iodide = about 22.7 min; lauryl iodide = about 25.6 min; myristyl iodide = about 31.1 min.<\/p>\n System suitability Reference solution:<\/p>\n \u2014 resolution: minimum 5.0 between the peaks due to 2-butyloctyl iodide and lauryl iodide.<\/p>\n Results The sum of the areas of the peaks eluted before the peak due to lauryl iodide is less than 10 percent of the area of the peak due to lauryl iodide; disregard the peak due to the solvent.<\/p>\n The solution is not more intensely coloured than reference solution BY5 (2.2.2, Method II).<\/p>\n Dissolve 5.0 g in ethanol (96 per cent) R and dilute to 50 mL with the same solvent.<\/p>\n Dissolve 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 Acid value (2.5.1)<\/em><\/strong><\/p>\n Maximum 1.0, determined on 5.0 g.<\/p>\n Hydroxyl value (2.5.3, Method A)<\/strong><\/p>\n 4<\/p>\n 5<\/p>\n 9<\/p>\n 10<\/p>\n 12<\/p>\n 15<\/p>\n 20 – 23<\/td>\n 145 – 165<\/p>\n 130 – 140<\/p>\n 90 – 100<\/p>\n 85 – 95<\/p>\n 73 – 83<\/p>\n 64 – 74<\/p>\n 40 – 60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Iodine value (2.5.4)<\/strong><\/p>\n Maximum 2.0.<\/p>\n Saponification value (2.5.6)<\/strong><\/p>\n Maximum 3.0, determined on 10.0 g.<\/p>\n Ethylene oxide and dioxan (2.4.25)<\/strong><\/p>\n Maximum 1 ppm of ethylene oxide and maximum 10 ppm of dioxan.<\/p>\n Water (2.5.12)<\/strong><\/p>\n Maximum 3.0 per cent, determined on 2.00 g.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.2 per cent.<\/p>\n Ignite a silica crucible at 600 \u00b1 50 \u00b0C for 30 min, allow to cool in a desiccator and weigh. Evenly distribute 1.0 g in the crucible and weigh again. Dry at 100-105 \u00b0C for 1 h and ignite in a muffle furnace at 600 \u00b1 25 \u00b0C until the substance is thoroughly charred. Carry out the test for sulfated ash on the residue obtained, starting from \u201cMoisten the substance to be examined…\u201d.<\/p>\n In an airtight container.<\/p>\n The label states the number of moles of ethylene oxide reacted per mole of C12<\/sub>H26<\/sub>O (nominal value).<\/p>\n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1124) Action and use Non-ionic surfactant. Ph Eur DEFINITION Mixture of ethers of mixed macrogols with linear fatty alcohols, mainly C12H26O. It contains a variable quantity of free C12H26O and may contain free macrogols. The number of moles of ethylene oxide reacted per mole of…<\/p>\n","protected":false},"author":5,"featured_media":21702,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-21701","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\/21701","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=21701"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21701\/revisions"}],"predecessor-version":[{"id":21707,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21701\/revisions\/21707"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21702"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21701"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21701"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21701"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
\nB. Iodine value (see Tests).
\nC. Saponification value (see Tests).
\nD. Dissolve or disperse 0.1 g in 5 mL of ethanol (96 per cent) R, add 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
\nprecipitate is formed.
\nE. Gas chromatography (2.2.28).<\/p>\n\n\n
\n <\/td>\n Time (min)<\/strong><\/td>\n Temperature (\u00b0C)<\/strong><\/td>\n<\/tr>\n \n Column<\/td>\n \u00a00 – 1<\/p>\n 120<\/p>\n \n Injection port<\/td>\n <\/td>\n 300<\/td>\n<\/tr>\n \n Detector<\/td>\n <\/td>\n 350<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \n\n
\n <\/td>\n Time (min)<\/td>\n Temperature (\u00b0C)<\/td>\n<\/tr>\n \n Column<\/td>\n 0 – 5<\/p>\n 100<\/p>\n \n Injection port<\/td>\n <\/td>\n 250<\/td>\n<\/tr>\n \n Detector<\/td>\n <\/td>\n 310<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n TESTS<\/h2>\n
Appearance of solution<\/h3>\n
Alkalinity<\/h3>\n
\n\n
\n Ethylene oxide units per molecule (nominal value)<\/td>\n Hydroxyl value<\/td>\n<\/tr>\n \n 3<\/p>\n 165 – 180<\/p>\n STORAGE<\/h2>\n
LABELLING<\/h2>\n