{"id":13219,"date":"2025-10-13T11:19:55","date_gmt":"2025-10-13T04:19:55","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=13219"},"modified":"2025-11-15T15:39:22","modified_gmt":"2025-11-15T08:39:22","slug":"fluocinolone-acetonide-dihydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/fluocinolone-acetonide-dihydrate\/","title":{"rendered":"Fluocinolone Acetonide Dihydrate"},"content":{"rendered":"<p>C<sub>24<\/sub>H<sub>30<\/sub>F<sub>2<\/sub>O<sub>6<\/sub>,2H<sub>2<\/sub>O\u00a0 \u00a0 \u00a0 \u00a0 488.5 (anhydrous)\u00a0 \u00a0 \u00a0 \u00a067-73-2<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Glucocorticoid.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Fluocinolone Cream<\/p>\n<p>Fluocinolone Ointment<\/p>\n<h2>DEFINITION<\/h2>\n<p>Fluocinolone Acetonide Dihydrate is 6\u03b1,9\u03b1-difluoro-11\u03b2,21-dihydroxy-16\u03b1-,17\u03b1-isopropylidenedioxypregna-1,4-diene-3,20- dione dihydrate. It contains not less than 96.0% and not more than 104.0% of C24H30F2O6, calculated with reference to the anhydrous substance.<\/p>\n<h2>CHARACTERISTICS<\/h2>\n<p>A white or almost white, crystalline powder.<\/p>\n<p>Practically insoluble in water; freely soluble in acetone; soluble in absolute ethanol; sparingly soluble in dichloromethane and in methanol; practically insoluble in hexane.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of fluocinolone acetonide dihydrate (RS 147).<\/p>\n<p>B. Complies with the test for identification of steroids, Appendix III A, using impregnating solvent I and mobile phase H. Apply 5 \u03bcL of each of the three solutions.<\/p>\n<p>C. Complies with the test for identification of steroids, Appendix III A, using the conditions specified in test B but using solutions prepared in the following manner. For solution (1) dissolve 10 mg in 1.5 mL of glacial acetic acid in a separating funnel, add 0.5 mL of a 2% w\/v solution of chromium(VI) oxide and allow to stand for 30 minutes. Add 5 mL of water and 2 mL of dichloromethane and shake vigorously for 2 minutes. Allow to separate and use the lower layer. Prepare solution (2) in the same manner but using 10 mg of fluocinolone acetonide BPCRS.<\/p>\n<h2>TESTS<\/h2>\n<h3>Light absorption<\/h3>\n<p>Dissolve 15 mg in sufficient absolute ethanol to produce 100 mL. Dilute 10 mL of the solution to 100 mL with absolute ethanol. The A(1%, 1 cm) of the resulting solution at the maximum at 239 nm is 345 to 375, calculated with reference to the anhydrous substance, Appendix II B.<\/p>\n<h3>Specific optical rotation<\/h3>\n<p>In a 1% w\/v solution in 1,4-dioxan, +92 to +96, calculated with reference to the anhydrous substance, Appendix V F.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) 0.25% w\/v of the substance being examined in acetonitrile.<\/p>\n<p>(2) 0.025% w\/v each of fluocinolone acetonide BPCRS and triamcinolone acetonide BPCRS in 45% w\/v of acetonitrile.<\/p>\n<p>(3) Dilute 1 volume of solution (1) to 100 volumes with acetonitrile.<\/p>\n<p>(4) Dilute 1 volume of solution (3) to 20 volumes with acetonitrile.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil BDS is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 238 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for 4 times the retention time of the principal peak.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>45 volumes of acetonitrile and 55 volumes of water.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless:<br \/>\nin the chromatogram obtained with solution (2), the resolution factor between the peaks due to triamcinolone acetonide and fluocinolone acetonide is at least 3.0; in the chromatogram obtained with solution (4), the signal-to-noise ratio of the principal peak is at least 10.<\/p>\n<h3>LIMITS<\/h3>\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 (3) (1%);<\/p>\n<p>the area of not more than one secondary peak is greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (3) (2.5%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.05%).<\/p>\n<h4>Water<\/h4>\n<p>7.0 to 8.5% w\/w, Appendix IX C. Use 0.5 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the tetrazolium assay of steroids, Appendix VIII J, and calculate the content of C<sub>24<\/sub>H<sub>30<\/sub>F<sub>2<\/sub>O<sub>6 <\/sub>from the absorbance obtained by repeating the operation using fluocinolone acetonide BPCRS in place of the substance being examined.<\/p>\n<h2>STORAGE<\/h2>\n<p>Fluocinolone Acetonide Dihydrate should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>C24H30F2O6,2H2O\u00a0 \u00a0 \u00a0 \u00a0 488.5 (anhydrous)\u00a0 \u00a0 \u00a0 \u00a067-73-2 Action and use Glucocorticoid. Preparations Fluocinolone Cream Fluocinolone Ointment DEFINITION Fluocinolone Acetonide Dihydrate is 6\u03b1,9\u03b1-difluoro-11\u03b2,21-dihydroxy-16\u03b1-,17\u03b1-isopropylidenedioxypregna-1,4-diene-3,20- dione dihydrate. It contains not less than 96.0% and not more than 104.0% of C24H30F2O6, calculated with reference to the anhydrous substance. CHARACTERISTICS A white or almost white, crystalline powder. Practically&#8230;<\/p>\n","protected":false},"author":2,"featured_media":13226,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-13219","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\/13219","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=13219"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13219\/revisions"}],"predecessor-version":[{"id":13228,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13219\/revisions\/13228"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/13226"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=13219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=13219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=13219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}