\n| 8<\/td>\n | 400<\/td>\n | 85 to 105<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nAlkaline impurities<\/h4>\nIntroduce 5.0 g into a test-tube and carefully add a mixture, neutralised if necessary with 0.01 M hydrochloric acid or with 0.01 M sodium hydroxide, of 0.05 mL of a 0.4 g\/L solution of bromophenol blue R in ethanol (96 per cent) R, 0.3 mL of water R and 10 mL of ethanol (96 per cent) R. Shake and allow to stand. Not more than 1.0 mL of 0.01 M hydrochloric acid is required to change the colour of the upper layer to yellow.<\/p>\n Free glycerol<\/h3>\nMaximum 5.0 per cent.<\/p>\n Dissolve 1.20 g in 25.0 mL of methylene chloride R. Heat if necessary. After cooling, add 100 mL of water R. Shake and add 25.0 mL of periodic acetic acid solution R. Shake and allow to stand for 30 min. Add 40 mL of a 75 g\/L solution of potassium iodide R. Allow to stand for 1 min. Add 1 mL of starch solution R. Titrate the iodine with 0.1 M sodium thiosulfate. Carry out a blank titration.<\/p>\n 1 mL of 0.1 M sodium thiosulfate is equivalent to 2.3 mg of glycerol.<\/p>\n Composition of fatty acids (2.4.22, Method A)<\/h4>\nComposition of the fatty-acid fraction of the substance:<\/p>\n \u2014 caproic acid: maximum 2.0 per cent;<\/p>\n \u2014 caprylic acid: 50.0 per cent to 80.0 per cent;<\/p>\n \u2014 capric acid: 20.0 per cent to 50.0 per cent;<\/p>\n \u2014 lauric acid: maximum 3.0 per cent;<\/p>\n \u2014 myristic acid: maximum 1.0 per cent.<\/p>\n Ethylene oxide and dioxan (2.4.25)<\/h4>\nMaximum 1 ppm of ethylene oxide and maximum 10 ppm of dioxan.<\/p>\n Water (2.5.12)<\/h4>\nMaximum 1.0 per cent, determined on 1.00 g. Use a mixture of 30 volumes of anhydrous methanol R and 70 volumes of methylene chloride R as solvent.<\/p>\n Total ash (2.4.16)<\/h4>\nMaximum 0.1 per cent.<\/p>\n LABELLING<\/h2>\nThe label states the type of macrogol used (mean relative molecular mass) or the number of ethylene oxide units per molecule (nominal value).<\/p>\n FUNCTIONALITY-RELATED CHARACTERISTICS<\/h2>\nThis section provides information on characteristics that are recognised as being relevant control parameters for one or more functions of the substance when used as an excipient (see chapter 5.15). Some of the characteristics described in the Functionality-related characteristics section may also be present in the mandatory part of the monograph since the also represent mandatory quality criteria. In such cases, a cross-reference to the tests described in the mandatory part is included in the Functionality-related characteristics section. Control of the characteristics can contribute to the quality of a
\nmedicinal product by improving the consistency of the manufacturing process and the performance of the medicinal product during use. Where control methods are cited, they are recognised as being suitable for the purpose, but other methods can also be used. Wherever results for a particular characteristic are reported, the control method must be indicated.<\/p>\n The following characteristics may be relevant for caprylocaproyl macrogolglycerides used as self-emulsifying agents and solubilisers.<\/p>\n Hydroxyl value<\/p>\n (see Tests).<\/p>\n Saponification value<\/p>\n (see Tests).<\/p>\n Composition of fatty acids<\/p>\n (see Tests).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1184) Action and use Excipient. DEFINITION Mixtures of monoesters, diesters and triesters of glycerol and monoesters and diesters of macrogols with a mean relative molecular mass between 200 and 400. They are obtained by partial alcoholysis of medium-chain triglycerides using macrogol, or by esterification of glycerol and macrogol with caprylic (octanoic) acid…<\/p>\n","protected":false},"author":3,"featured_media":4169,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-4167","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\/4167","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=4167"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4167\/revisions"}],"predecessor-version":[{"id":5613,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4167\/revisions\/5613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4169"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}} |