Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n
Preparations<\/strong><\/p>\n Nabumetone Oral Suspension Nabumetone Tablets<\/p>\n Ph Eur<\/p>\n 4-(6-Methoxynaphthalen-2-yl)butan-2-one.<\/p>\n Content<\/strong><\/p>\n 97.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n White or almost white, crystalline powder.<\/p>\n Practically insoluble in water, freely soluble in acetone, slightly soluble in methanol.<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 nabumetone CRS.<\/em><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution (a)\u00a0<\/em> Dissolve 50.0 mg of the substance to be examined in acetonitrile R and dilute to 10.0 mL with the same solvent.<\/p>\n Test solution (b)\u00a0<\/em> Dilute 1.0 mL of test solution (a) to 25.0 mL with acetonitrile R. Dilute 1.0 mL of this solution to 5.0 mL with acetonitrile R.<\/p>\n Reference solution (a)\u00a0<\/em> Dissolve 20.0 mg of nabumetone CRS in acetonitrile R and dilute to 10.0 mL with the same solvent. Dilute 1.0 mL of this solution to 50.0 mL with acetonitrile R.<\/p>\n Reference solution (b)\u00a0<\/em> Dilute 0.5 mL of test solution (a) to 100.0 mL with acetonitrile R.<\/p>\n Reference solution (c)<\/em>\u00a0 Dissolve 1.5 mg of nabumetone impurity F CRS in acetonitrile R and dilute to 100.0 mL with the same solvent.<\/p>\n Reference solution (d)<\/em>\u00a0 Dissolve 4 mg of nabumetone impurity D CRS in acetonitrile R and dilute to 100 mL with the same solvent. To 5 mL of this solution, add 5 mL of test solution (b).<\/p>\n Column:<\/em><\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase:<\/em> base-deactivated octadecylsilyl silica gel for chromatography R (4 \u00b5m);<\/p>\n \u2014 temperature:<\/em> 40 \u00b0C.<\/p>\n Mobile phase:<\/em><\/p>\n \u2014 mobile phase A:<\/em> mix 12 volumes of tetrahydrofuran R, 28 volumes of acetonitrile for chromatography R and 60 volumes of a 0.1 per cent V\/V solution of glacial acetic acid R in carbon dioxide-free water R prepared from distilled water R;<\/p>\n \u2014 mobile phase B:<\/em> mix 24 volumes of tetrahydrofuran R, 56 volumes of acetonitrile for chromatography R and 20 volumes of a 0.1 per cent V\/V solution of glacial acetic acid R in carbon dioxide-free water R prepared from distilled water R;<\/p>\n Flow rate\u00a0 1 mL\/min.<\/p>\n Detection<\/em>\u00a0 Spectrophotometer at 254 nm.<\/p>\n Injection<\/em>\u00a0 20 \u00b5L of test solution (a) and reference solutions (b), (c) and (d).<\/p>\n Retention time<\/em>\u00a0 Nabumetone = about 11 min.<\/p>\n System suitability<\/em>\u00a0 Reference solution (d):<\/p>\n \u2014 resolution:<\/em> minimum 1.5 between the peaks due to nabumetone and impurity D.<\/p>\n Limits:<\/em><\/p>\n \u2014 impurity F:<\/em> not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.3 per cent);<\/p>\n \u2014 unspecified impurities:<\/em> for each impurity, not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n \u2014 sum of impurities other than F:<\/em> not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n \u2014 disregard limit:<\/em> 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n Water (2.5.12)<\/strong><\/p>\n Maximum 0.2 per cent, determined on 1.000 g.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/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 Injection<\/em>\u00a0 Test solution (b) and reference solution (a).<\/p>\n System suitability<\/em>\u00a0 Reference solution (a):<\/p>\n \u2014 repeatability:<\/em> maximum relative standard deviation of 1.0 per cent after 6 injections.<\/p>\n Calculate the percentage content of C15<\/sub>H16<\/sub>O2<\/sub> from the declared content of nabumetone CRS.<\/p>\n Protected from light.<\/p>\n Specified impurities\u00a0 F.<\/em><\/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.<\/em><\/p>\n Control of impurities in substances for pharmaceutical use)\u00a0 A, B, C, D, E.<\/em><\/p>\n A. 3-(6-methoxynaphthalen-2-yl)-5-methylcyclohexanone,<\/p>\n B. (5RS)-5-(6-methoxynaphthalen-2-yl)-3-methylcyclohex-2-enone,<\/p>\n C. (2RS)-4-(6-methoxynaphthalen-2-yl)butan-2-ol,<\/p>\n D. (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one,<\/p>\n E. 1,5-bis(6-methoxynaphthalen-2-yl)pentan-3-one,<\/p>\n F. 6,6\u2032-dimethoxy-2,2\u2032-binaphthalenyl.<\/p>\n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. Preparations Nabumetone Oral Suspension Nabumetone Tablets Ph Eur DEFINITION 4-(6-Methoxynaphthalen-2-yl)butan-2-one. Content 97.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone, slightly soluble in methanol….<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25513","post","type-post","status-publish","format-standard","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25513","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=25513"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25513\/revisions"}],"predecessor-version":[{"id":25546,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25513\/revisions\/25546"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25513"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25513"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25513"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nDEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
\n\n
\n Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n \n 0 – 12<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n \n 12 – 28<\/td>\n 100 \u2192 0<\/td>\n 0 \u2192 100<\/td>\n<\/tr>\n \n 28 – 33<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-1.jpg\")
<\/p>\n![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-2.jpg\")
<\/p>\n![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-3.jpg\")
<\/p>\n![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-4.jpg\")
<\/p>\n![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-5.jpg\")
<\/p>\n![\"Nabumetone\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nabumetone-British-Pharmacopoeia-2025-6.jpg\")
<\/p>\n
\n