![\"C24H40N2O10S\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/C24H40N2O10S.jpg\")
<\/p>\n(Ph. Eur. 11.6 update)<\/p>\n
(Ph. Eur. monograph 0690)<\/p>\n
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C24<\/sub>H40<\/sub>N2<\/sub>O10<\/sub>S\u00a0 \u00a0 \u00a0 \u00a0548.6\u00a0 \u00a0 \u00a0 \u00a023031-32-5<\/p>\n Action and use<\/strong><\/p>\n Beta2-adrenoceptor agonist; bronchodilator.<\/p>\n Preparation<\/strong><\/p>\n Terbutaline Tablets<\/p>\n Bis[5-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol] sulfate.<\/p>\n Content<\/strong><\/p>\n 98.5 per cent to 101.0 per cent (dried substance).<\/p>\n Appearance<\/strong><\/p>\n White or almost white, crystalline powder.<\/p>\n Solubility<\/strong><\/p>\n Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in heptane.<\/p>\n It shows polymorphism (5.9).<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison terbutaline sulfate CRS.<\/p>\n If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in aldehyde-free methanol R, evaporate to dryness and record new spectra using the residues.<\/p>\n B. 5 mL of solution S (see Tests) gives reaction (a) of sulfates (2.3.1).<\/p>\n Solution S<\/strong><\/p>\n Dissolve 1.0 g in carbon dioxide-free water R and dilute to 50.0 mL with the same solvent.<\/p>\n Appearance of solution<\/strong><\/p>\n Solution S is clear (2.2.1) and its absorbance (2.2.25) at 400 nm in a 2 cm cell is not greater than 0.11.<\/p>\n Acidity<\/strong><\/p>\n To 10 mL of solution S add 0.05 mL of methyl red solution R. Not more than 1.2 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to yellow.<\/p>\n Optical rotation (2.2.7)<\/p>\n -0.10\u00b0 to +0.10\u00b0, determined on solution S.<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution<\/p>\n Dissolve 75.0 mg of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n Reference solution (a)<\/p>\n Dissolve 7.5 mg of terbutaline impurity C CRS and 22.5 mg of terbutaline sulfate CRS in the mobile phase and dilute to 50 mL with the mobile phase. Dilute 1 mL of the solution to 100 mL with the mobile phase.<\/p>\n Reference solution (b)<\/p>\n Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n Mobile phase<\/p>\n Prepare a 0.050 M ammonium formate solution as follows: dissolve 3.15 g of ammonium formate R in about 980 mL of water for chromatography R, adjust to pH 3.0 by adding about 8 mL of anhydrous formic acid R and dilute to 1000 mL with water for chromatography R. Dissolve 4.23 g of sodium hexanesulfonate R in 770 mL of the 0.050 M ammonium formate solution, then add 230 mL of methanol R.<\/p>\n Flow rate\u00a0 1.0 mL\/min.<\/p>\n Detection\u00a0 \u00a0 Spectrophotometer at 276 nm.<\/p>\n Injection\u00a0 20 \u03bcL.<\/p>\n Run time.\u00a0 \u00a06 times the retention time of terbutaline.<\/p>\n Identification of impurities\u00a0 \u00a0 Use the chromatogram obtained with reference solution (a) to identify the peak due to impurity C.<\/p>\n Relative retention.\u00a0 With reference to terbutaline (retention time = about 10 min): impurity C = about 0.9.<\/p>\n System suitability.\u00a0 \u00a0 \u00a0Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to impurity C and terbutaline.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of terbutaline sulfate in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.2 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Loss on drying (2.2.32)<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n Dissolve 0.400 g in 70 mL of anhydrous acetic acid R with heating. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n 1 mL of 0.1 M perchloric acid is equivalent to 54.86 mg of. C24<\/sub>H40<\/sub>N2<\/sub>O10<\/sub>S<\/p>\n Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, B, C, D.<\/p>\n A. 3,5-dihydroxybenzoic acid (\u03b1-resorcylic acid)<\/p>\n B. (4RS)-2-tert-butyl-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol<\/p>\n C. 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl)ethan-1-one<\/p>\n D. 2-[benzyl(tert-butyl)amino]-1-(3,5-dihydroxyphenyl)ethan-1-one<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) (Ph. Eur. monograph 0690) C24H40N2O10S\u00a0 \u00a0 \u00a0 \u00a0548.6\u00a0 \u00a0 \u00a0 \u00a023031-32-5 Action and use Beta2-adrenoceptor agonist; bronchodilator. Preparation Terbutaline Tablets DEFINITION Bis[5-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol] sulfate. Content 98.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water, slightly soluble in ethanol (96…<\/p>\n","protected":false},"author":4,"featured_media":31341,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31332","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\/31332","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=31332"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31332\/revisions"}],"predecessor-version":[{"id":31343,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31332\/revisions\/31343"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31341"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31332"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31332"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
ASSAY<\/h2>\n
IMPURITIES<\/h2>\n
![\"A.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/A.-35-dihydroxybenzoic-acid-\u03b1-resorcylic-acid.jpg\")
<\/p>\n![\"B.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/B.-4RS-2-tert-butyl-1234-tetrahydroisoquinoline-468-triol.jpg\")
<\/p>\n![\"C.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/C.-2-tert-butylamino-1-35-dihydroxyphenylethan-1-one.jpg\")
<\/p>\n![\"D.](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/D.-2-benzyltert-butylamino-1-35-dihydroxyphenylethan-1-one.jpg\")
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