Action and use<\/strong><\/p>\n Beta2 -adrenoceptor agonist; bronchodilator.<\/p>\n Preparations<\/strong><\/p>\n Fluticasone and Salmeterol Inhalation Powder, pre-metered<\/p>\n Fluticasone and Salmeterol Inhalation Powder<\/p>\n Fluticasone and Salmeterol Pressurised Inhalation, Suspension<\/p>\n Salmeterol Inhalation Powder, pre-metered<\/p>\n Salmeterol Pressurised Inhalation, Suspension<\/p>\n (1RS)-1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol 1-hydroxynaphthalene-2- carboxylate.<\/p>\n 97.5 per cent to 102.0 per cent (anhydrous substance).<\/p>\n White or almost white powder.<\/p>\n Practically insoluble in water, soluble in methanol, slightly soluble in anhydrous ethanol, practically insoluble in methylene chloride.<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: salmeterol xinafoate CRS.<\/p>\n Liquid chromatography (2.2.29). Protect the solutions from light.<\/p>\n Solvent mixture acetonitrile R, water R (50:50 V\/V).<\/p>\n Test solution (a): Dissolve 50.0 mg of the substance to be examined in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n Test solution (b): Dissolve 25.0 mg of the substance to be examined in mobile phase A and dilute to 100.0 mL with mobile phase A.<\/p>\n Reference solution (a): Dissolve the contents of a vial of salmeterol xinafoate for system suitability CRS (containing impurities E and G) in 1 mL of the solvent mixture.<\/p>\n Reference solution (b): Dilute 1.0 mL of test solution (a) to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n Reference solution (c): Dissolve 5 mg of salmeterol xinafoate for peak identification CRS (containing impurity D) in the solvent mixture and dilute to 1.0 mL with the solvent mixture.<\/p>\n Reference solution (d): Dissolve 25.0 mg of salmeterol xinafoate CRS in mobile phase A and dilute to 100.0 mL with mobile phase A.<\/p>\n Reference solution (e): Dilute 1.0 mL of reference solution (a) to 20.0 mL with mobile phase A.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n Mobile phase:<\/p>\n \u2014 mobile phase A: mix 24 volumes of a 7.71 g\/L solution of ammonium acetate R and 24 volumes of a 28.84 g\/L solution of sodium dodecyl sulfate R and adjust to pH 2.7 with glacial acetic acid R; mix with 52 volumes of acetonitrile R;<\/p>\n \u2014 mobile phase B: acetonitrile R;<\/p>\n Flow rate: 2 mL\/min.<\/p>\n Detection: Spectrophotometer at 278 nm.<\/p>\n Injection: 20 \u03bcL of test solution (a) and reference solutions (a), (b) and (c).<\/p>\n Identification of impurities: Use the chromatogram supplied with salmeterol xinafoate for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities E and G; use the chromatogram supplied with salmeterol xinafoate for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peak due to impurity D.<\/p>\n Relative retention: With reference to salmeterol (retention time = about 13 min): xinafoic acid = about 0.2; impurity D = about 0.8; impurity E = about 0.9; impurity G = about 2.7.<\/p>\n System suitability: Reference solution (a):<\/p>\n \u2014 peak-to-valley ratio: minimum 10, where Hp<\/sub> = height above the baseline of the peak due to impurity E and Hv<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to salmeterol.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of salmeterol xinafoate in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 impurities D, G: for each impurity, maximum 0.2 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent; disregard the peak due to xinafoic acid.<\/p>\n Maximum 0.5 per cent, determined on 1.00 g.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n Mobile phase: Mobile phase A.<\/p>\n Injection: 20 \u03bcL of test solution (b) and reference solutions (d) and (e).<\/p>\n Run time: Until complete elution of the peak due to salmeterol (about 16 min).<\/p>\n System suitability: Reference solution (e):<\/p>\n \u2014 peak-to-valley ratio: minimum 10, where Hp = height above the baseline of the peak due to impurity E and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to salmeterol.<\/p>\n Calculate the percentage content of C36<\/sub>H45<\/sub>NO7<\/sub>\u00a0using the chromatogram obtained with reference solution (d) and taking into account the assigned content of salmeterol xinafoate CRS.<\/p>\n Protected from light.<\/p>\n Specified impurities D, G.<\/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, E, F.<\/p>\n A. (1RS)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]-2-[(4-phenylbutyl)amino]ethanol,<\/p>\n B. (1RS)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(2-phenylethoxy)hexyl]amino]ethanol,<\/p>\n C. (1RS)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(3-phenylpropoxy)hexyl]amino]ethanol,<\/p>\n D. 1-[4-[2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethoxy]-3-(hydroxymethyl)phenyl]-2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol,<\/p>\n E. 1-[4-hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(1-methyl-3-phenylpropoxy)hexyl]amino]ethanol,<\/p>\n F. (1RS)-1-(4-hydroxy-3-methylphenyl)-2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol,<\/p>\n G. 1-[4-hydroxy-3-[[[2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl][6-(4-phenylbutoxy)hexyl]amino]methyl]phenyl]-2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1765) C36H45NO7\u00a0 \u00a0 \u00a0 \u00a0 604\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a094749-08-3 Action and use Beta2 -adrenoceptor agonist; bronchodilator. Preparations Fluticasone and Salmeterol Inhalation Powder, pre-metered Fluticasone and Salmeterol Inhalation Powder Fluticasone and Salmeterol Pressurised Inhalation, Suspension Salmeterol Inhalation Powder, pre-metered Salmeterol Pressurised Inhalation, Suspension DEFINITION (1RS)-1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol 1-hydroxynaphthalene-2- carboxylate. Content 97.5 per cent…<\/p>\n","protected":false},"author":2,"featured_media":29170,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29136","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\/29136","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=29136"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29136\/revisions"}],"predecessor-version":[{"id":29181,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29136\/revisions\/29181"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29170"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
\n\n
\n Time<\/strong>
\n(min)<\/strong><\/td>\nMobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\nMobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n\n 0 – 16<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n \n 16 – 36<\/td>\n 100 \u2192 30<\/td>\n 0 \u2192 70<\/td>\n<\/tr>\n \n 36 – 45<\/td>\n 30<\/td>\n 70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Water (2.5.12)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-2-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-3-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-4-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-5-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-6-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-7-300x163.jpg\")
<\/p>\n![\"Salmeterol](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Salmeterol-Xinafoate-8-300x163.jpg\")
<\/p>\n