{"id":12192,"date":"2025-10-10T16:45:51","date_gmt":"2025-10-10T09:45:51","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=12192"},"modified":"2025-10-10T16:45:51","modified_gmt":"2025-10-10T09:45:51","slug":"fluorometholone","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/fluorometholone\/","title":{"rendered":"Fluorometholone"},"content":{"rendered":"<p>C<sub>22<\/sub>H<sub>29<\/sub>FO<sub>4<\/sub>\u00a0 \u00a0376.5\u00a0 \u00a0426-13-1<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Glucocorticoid.<\/p>\n<p><strong>Preparation<\/strong><\/p>\n<p>Fluorometholone Eye Drops<\/p>\n<h2>DEFINITION<\/h2>\n<p>Fluorometholone is 9\u03b1-fluoro-11\u03b2,17\u03b1-dihydroxy-6\u03b1-methylpregna-1,4-diene-3,20-dione. It contains not less than 97.0% and not more than 103.0% of C<sub>22<\/sub>H<sub>29<\/sub>FO<sub>4<\/sub>, calculated with reference to the dried substance.<\/p>\n<h2>CHARACTERISTICS<\/h2>\n<p>A white to yellowish white, crystalline powder. It melts at about 280\u00b0, with decomposition.<\/p>\n<p>Practically insoluble in water; slightly soluble in absolute ethanol and in ether.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of fluorometholone (RS152).<\/p>\n<p>B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Specific optical rotation<\/h3>\n<p>In a 1% w\/v solution in pyridine, +52 to +60, Appendix V F, calculated with reference to the dried substance.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in methanol.<\/p>\n<p>(1) 0.010% w\/v of the substance being examined.<\/p>\n<p>(2) 0.00005% w\/v of the substance being examined.<\/p>\n<p>(3) 0.00005% w\/v each of deltamedrane BPCRS and fluorometholone BPCRS.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (30 cm \u00d7 3.9 mm) packed with octadecylsilyl silica gel for chromatography (10 \u03bcm) (\u03bcBondapak C18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 254 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>40 volumes of water and 60 volumes of methanol.<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to deltamedrane and fluorometholone is at least 1.5.<\/p>\n<h4>LIMITS<\/h4>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%); the sum of the areas of any secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/p>\n<h4>Loss on drying<\/h4>\n<p>When dried at 60\u00b0 at a pressure not exceeding 0.7 kPa for 3 hours, loses not more than 0.5% of its weight. Use 1 g.<\/p>\n<h4>Sulfated ash<\/h4>\n<p>Not more than 0.1%, Appendix IX A.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in methanol.<\/p>\n<p>(1) 0.005% w\/v of the substance being examined.<\/p>\n<p>(2) 0.005% w\/v of fluorometholone BPCRS.<\/p>\n<p>(3) 0.00005% w\/v each of deltamedrane BPCRS and fluorometholone BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Related substances may be used.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to deltamedrane and fluorometholone is at least 1.5.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>22<\/sub>H<sub>29<\/sub>FO<sub>4<\/sub> from the chromatograms obtained and using the declared content of C<sub>22<\/sub>H<sub>29<\/sub>FO<sub>4<\/sub> in fluorometholone BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-12213\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-118-300x163.jpg\" alt=\"Fluorometholone-1\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-118-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-118-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-118-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/1-118.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. 11\u03b2,17\u03b1-dihydroxy-6\u03b1-methylpregna-1,4-diene-3,20-dione (deltamedrane),<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-12214\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-117-300x163.jpg\" alt=\"Fluorometholone-2\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-117-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-117-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-117-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-117.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. 9\u03b2,11\u03b2-epoxy-17\u03b1-hydroxy-6\u03b1-methylpregna-1,4-diene-3,20-dione (epoxymedradiene).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>C22H29FO4\u00a0 \u00a0376.5\u00a0 \u00a0426-13-1 Action and use Glucocorticoid. Preparation Fluorometholone Eye Drops DEFINITION Fluorometholone is 9\u03b1-fluoro-11\u03b2,17\u03b1-dihydroxy-6\u03b1-methylpregna-1,4-diene-3,20-dione. It contains not less than 97.0% and not more than 103.0% of C22H29FO4, calculated with reference to the dried substance. CHARACTERISTICS A white to yellowish white, crystalline powder. It melts at about 280\u00b0, with decomposition. Practically insoluble in water; slightly&#8230;<\/p>\n","protected":false},"author":3,"featured_media":12215,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-12192","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\/12192","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=12192"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12192\/revisions"}],"predecessor-version":[{"id":12216,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12192\/revisions\/12216"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12215"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12192"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12192"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}