{"id":31130,"date":"2025-11-12T17:30:45","date_gmt":"2025-11-12T10:30:45","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=31130"},"modified":"2025-11-12T17:30:45","modified_gmt":"2025-11-12T10:30:45","slug":"sulindac","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/sulindac\/","title":{"rendered":"Sulindac"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 0864)<\/em><\/p>\n<p>C<sub>20<\/sub>H<sub>17<\/sub>FO<sub>3<\/sub>S 356.4 38194-50-2<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n<p><strong>Preparation<\/strong><\/p>\n<p>Sulindac Tablets<\/p>\n<h2>DEFINITION<\/h2>\n[(1Z)-6-Fluoro-3-[[4-[(RS)-methanesulfinyl]phenyl]methylidene]-2-methyl-3H-inden-1-yl]acetic acid.<\/p>\n<h3>Content<\/h3>\n<p>99.0 per cent to 101.0 per cent (dried substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>Yellow, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Very slightly soluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides.<\/p>\n<p>It shows polymorphism (5.9).<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison sulindac CRS.<\/p>\n<p>If the spectra obtained show differences, dissolve the substance to be examined and the reference substance separately in the minimum volume of hot methanol R, evaporate to dryness and record new spectra using the residues.<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29).<\/p>\n<p>Test solution: Dissolve 0.10 g of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n<p>Reference solution (a): 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<p>Reference solution (b): Dissolve 4 mg of sulindac for system suitability CRS (containing impurities B, C and D) in the mobile phase and dilute to 2 mL with the mobile phase.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n<p>\u2014 stationary phase: silica gel for chromatography R (10 \u03bcm).<\/p>\n<p>Mobile phase: glacial acetic acid R, ethanol (96 per cent) R, ethyl acetate R, methylene chloride R (1:4:100:400 V\/V\/V\/V).<\/p>\n<p>Flow rate: 2 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 280 nm.<\/p>\n<p>Injection: 20 \u03bcL.<\/p>\n<p>Run time: 2.5 times the retention time of sulindac.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with sulindac for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities B, C and D.<\/p>\n<p>Relative retention: With reference to sulindac (retention time = about 10 min): impurity C = about 0.20; impurity B = about 0.25; impurity D = about 0.7.<\/p>\n<p>System suitability: Reference solution (b):<\/p>\n<p>\u2014 resolution: minimum 2.0 between the peaks due to impurities C and B.<\/p>\n<p>Calculation of percentage contents:<\/p>\n<p>\u2014 correction factor: multiply the peak area of impurity C by 2;<\/p>\n<p>\u2014 for each impurity, use the concentration of sulindac in reference solution (a).<\/p>\n<p>Limits:<\/p>\n<p>\u2014 impurity C: maximum 0.5 per cent;<\/p>\n<p>\u2014 impurity B: maximum 0.4 per cent;<\/p>\n<p>\u2014 impurity D: maximum 0.2 per cent;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n<p>\u2014 total: maximum 1.0 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.05 per cent.<\/p>\n<h3>Loss on drying (2.2.32)<\/h3>\n<p>Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C at a pressure not exceeding 0.7 kPa.<\/p>\n<h3>Sulfated ash (2.4.14)<\/h3>\n<p>Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.300 g in 50 mL of methanol R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n<p>1 mL of 0.1 M sodium hydroxide is equivalent to 35.64 mg of C<sub>20<\/sub>H<sub>17<\/sub>FO<sub>3<\/sub>.<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities B, C, D.<\/p>\n<p>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.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-31143\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-85-300x163.jpg\" alt=\"Sulindac \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-85-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-85-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-85-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-85.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. [(1E)-6-fluoro-3-[[4-[(RS)-methanesulfinyl]phenyl]methylidene]-2-methyl-3H-inden-1-yl]acetic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-31144\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-84-300x163.jpg\" alt=\"Sulindac \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-84-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-84-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-84-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-84.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. [(1Z)-6-fluoro-3-[[4-(methanesulfonyl)phenyl]methylidene]-2-methyl-3H-inden-1-yl]acetic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-31146\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-80-300x163.jpg\" alt=\"Sulindac \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-80-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-80-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-80-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-80.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. [(1Z)-6-fluoro-2-methyl-3-[[4-(methylsulfanyl)phenyl]methylidene]-3H-inden-1-yl]acetic acid,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-31147\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-73-300x163.jpg\" alt=\"Sulindac \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-73-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-73-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-73-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/5-73.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>D. methyl [(1Z)-6-fluoro-3-[[4-[(RS)-methanesulfinyl]phenyl]methylidene]-2-methyl-3H-inden-1-yl]acetate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 0864) C20H17FO3S 356.4 38194-50-2 Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. Preparation Sulindac Tablets DEFINITION [(1Z)-6-Fluoro-3-[[4-[(RS)-methanesulfinyl]phenyl]methylidene]-2-methyl-3H-inden-1-yl]acetic acid. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance Yellow, crystalline powder. Solubility Very slightly soluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96 per cent). It dissolves in&#8230;<\/p>\n","protected":false},"author":4,"featured_media":31142,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31130","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\/31130","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=31130"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31130\/revisions"}],"predecessor-version":[{"id":31158,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31130\/revisions\/31158"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31142"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31130"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31130"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31130"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}