﻿{"id":30173,"date":"2025-11-11T15:33:37","date_gmt":"2025-11-11T08:33:37","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=30173"},"modified":"2025-11-11T15:33:37","modified_gmt":"2025-11-11T08:33:37","slug":"sodium-fusidate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/sodium-fusidate\/","title":{"rendered":"Sodium Fusidate"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Antibacterial.<\/p>\n<p><strong>Preparation<\/strong><\/p>\n<p>Sodium Fusidate Ointment Ph Eur<\/p>\n<h2>DEFINITION<\/h2>\n<p>Sodium ent-(17Z)-16\u03b1-(acetyloxy)-3\u03b2,11\u03b2-dihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oate. Antimicrobial substance produced by fermentation of certain strains of Fusidium coccineum or by any other means.<\/p>\n<p><strong>Content<\/strong><\/p>\n<p>97.5 per cent to 101.0 per cent (anhydrous substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white, crystalline powder, slightly hygroscopic.<\/p>\n<h3>Solubility<\/h3>\n<h2>Freely soluble in water and in ethanol (96 per cent).<\/p>\n<p>IDENTIFICATION<\/h2>\n<p>A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison\u00a0 sodium fusidate CRS.<\/p>\n<p>B. Ignite 1 g. The residue gives reaction (a) of sodium (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is not more intensely coloured than reference solution B6 (2.2.2, Method II). Dissolve 1.5 g in 10 mL of water R.<\/p>\n<p><strong>pH (2.2.3)<\/strong><\/p>\n<p>7.5 to 9.0.<\/p>\n<p>Dissolve 0.125 g in 10 mL of carbon dioxide-free water R.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n<p>Solvent mixture\u00a0 methanol R, 5 g\/L solution of phosphoric acid R, acetonitrile R (10:40:50 V\/V\/V).<\/p>\n<p>Test solution Dissolve 25 mg of the substance to be examined in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (a) Dissolve 2 mg of fusidic acid for peak identification CRS (containing impurities A, B, C, D, F, G, H and N) in the solvent mixture and dilute to 1.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (b)\u00a0 Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (c)\u00a0 Dilute 1.0 mL of reference solution (b) to 10.0 mL with the solvent mixture.<\/p>\n<p>Reference solution (d) Dissolve the contents of a vial of fusidic acid impurity mixture CRS (containing impurities I, K, L and M) in 1.0 mL of the solvent mixture.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n<p>\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (3.5 \u00b5m);<\/p>\n<p>\u2014 temperature: 30 \u00b0C.<\/p>\n<p>Mobile phase:<\/p>\n<p>\u2014 mobile phase A: methanol R, acetonitrile R, 5 g\/L solution of phosphoric acid R (20:40:40 V\/V\/V);<\/p>\n<p>\u2014 mobile phase B: 5 g\/L solution of phosphoric acid R, methanol R, acetonitrile R (10:20:70 V\/V\/V);<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 84px;\">\n<tbody>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Time (min)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase A (per cent V\/V)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0 &#8211; 3<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">100<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">3 &#8211; 28<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">100 \u2192 0<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0 \u2192 100<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">28 &#8211; 33<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate\u00a0 1.0 mL\/min.<\/p>\n<p>Detection\u00a0 Spectrophotometer at 235 nm.<\/p>\n<p>Injection\u00a0 20 \u00b5L.<\/p>\n<p>Identification of impurities Use the chromatogram supplied with fusidic acid for peak identification CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B, C, D, F, G, H and N; use the chromatogram supplied with fusidic acid impurity mixture CRS and the chromatogram obtained with reference solution (d) to identify the peaks due to impurities I, K, L and M.<\/p>\n<p>Relative retention\u00a0 With reference to fusidic acid (retention time = about 18 min): impurity A = about 0.4; impurity B = about 0.5; impurity C = about 0.6; impurity D = about 0.63; impurity N = about 0.65; impurity F = about 0.7; impurity G = about 0.82; impurity H = about 0.85; impurity I = about 0.96; impurity K = about 1.18; impurity L = about 1.23; impurity M = about 1.4.<\/p>\n<p>System suitability\u00a0 Reference solution (a):<\/p>\n<p>\u2014 resolution: minimum 1.5 between the peaks due to impurities G and H.<\/p>\n<p>Limits:<\/p>\n<p>\u2014 correction factors: for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity C = 0.7; impurity D = 0.7; impurity F = 0.3; impurity I = 0.6; impurity K = 0.6;<\/p>\n<p>\u2014 impurity M: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n<p>\u2014 impurity G: not more than 0.7 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.7 per cent);<\/p>\n<p>\u2014 impurity L: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n<p>\u2014 impurity B: not more than 4 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.4 per cent);<\/p>\n<p>\u2014 impurity A: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.3 per cent);<\/p>\n<p>\u2014 impurities C, D, F, I, K, N: for each impurity, not more than twice the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent);<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.10 per cent);<\/p>\n<p>\u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);<\/p>\n<p>\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent).<\/p>\n<p><strong>Water (2.5.12)<\/strong><\/p>\n<p>Maximum 2.0 per cent, determined on 0.500 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.400 g in 30 mL of water R and add 40 mL of ethanol (96 per cent) R. Titrate with 0.1 M hydrochloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n<p>1 mL of 0.1 M hydrochloric acid is equivalent to 53.87 mg of C<sub>31<\/sub>H<sub>47<\/sub>NaO<sub>6<\/sub>.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container, protected from light, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n<h2>IMPURITIES<\/h2>\n<p><em>Specified impurities\u00a0 A, B, C, D, F, G, I, K, L, M, N.<\/em><\/p>\n<p><em>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) E, H, J, O.<\/em><\/p>\n<p>A. ent-(24SR,17Z)-16\u03b1-(acetyloxy)-3\u03b2,11\u03b2,24,25-tetrahydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholest-17(20)-en-21-oic acid (24,25-dihydro-24,25-dihydroxyfusidic acid),<\/p>\n<p>B. ent-(17Z)-3\u03b2,11\u03b2-dihydroxy-17-[(6SR)-6-hydroxy-7,7-dimethyl-2-oxooxepan-3-ylidene]-4\u03b2,8,14-trimethyl-18-nor- 5\u03b2,10\u03b1-androstan-16\u03b1-yl acetate (24,25-dihydro-24,25-dihydroxyfusidic acid 21,25-lactone),<\/p>\n<p>C. ent-(17Z)-3\u03b2,11\u03b2-dihydroxy-17-[(6S)-6-(1-hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4\u03b2,8,14- trimethyl-18-nor-5\u03b2,10\u03b1-androstan-16\u03b1-yl acetate ((24R)-24,25-dihydro-24,25-dihydroxyfusidic acid 21,24-lactone),<\/p>\n<p>D. ent-(17Z)-3\u03b2,11\u03b2-dihydroxy-17-[(6R)-6-(1-hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4\u03b2,8,14- trimethyl-18-nor-5\u03b2,10\u03b1-androstan-16\u03b1-yl acetate ((24S)-24,25-dihydro-24,25-dihydroxyfusidic acid 21,24-lactone),<\/p>\n<p>E. ent-(17Z,24EZ)-16\u03b1-(acetyloxy)-3\u03b2,11\u03b2,26-trihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (26-hydroxyfusidic acid),<\/p>\n<p>F. ent-(17Z,24EZ)-16\u03b1-(acetyloxy)-3\u03b2,11\u03b2-dihydroxy-4\u03b2,8,14-trimethyl-26-oxo-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21- oic acid (26-oxofusidic acid),<\/p>\n<p>G. ent-(17Z)-16\u03b1-(acetyloxy)-11\u03b2-hydroxy-4\u03b2,8,14-trimethyl-3-oxo-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (3- didehydrofusidic acid),<\/p>\n<p>H. ent-(17Z)-16\u03b1-(acetyloxy)-3\u03b2-hydroxy-4\u03b2,8,14-trimethyl-11-oxo-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (11-didehydrofusidic acid),<\/p>\n<p>I. ent-(17Z)-3\u03b2,11\u03b2,16\u03b2-trihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (16-epi- deacetylfusidic acid),<\/p>\n<p>J. ent-(17Z)-3\u03b2,11\u03b2-dihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dieno-21(16\u03b2)-lactone (16-epi- deacetylfusidic acid 21,16-lactone),<\/p>\n<p>K. ent-(17Z)-3\u03b2,11\u03b2-dihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dieno-21(16\u03b1)-lactone (deacetylfusidic acid 21,16-lactone),<\/p>\n<p>L. ent-(17Z)-16\u03b1-(acetyloxy)-3\u03b2-hydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-9(11),17(20),24-trien-21-oic acid (9,11-anhydrofusidic acid),<\/p>\n<p>M. ent-(17Z)-16\u03b1-(acetyloxy)-3\u03b2-hydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (11- deoxyfusidic acid),<\/p>\n<p>N. unknown structure,<\/p>\n<p>O. ent-(17Z)-3\u03b2,11\u03b2,16\u03b1-trihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oic acid (deacetylfusidic acid).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Antibacterial. Preparation Sodium Fusidate Ointment Ph Eur DEFINITION Sodium ent-(17Z)-16\u03b1-(acetyloxy)-3\u03b2,11\u03b2-dihydroxy-4\u03b2,8,14-trimethyl-18-nor-5\u03b2,10\u03b1-cholesta-17(20),24-dien-21-oate. Antimicrobial substance produced by fermentation of certain strains of Fusidium coccineum or by any other means. Content 97.5 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder, slightly&#8230;<\/p>\n","protected":false},"author":5,"featured_media":30174,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-30173","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\/30173","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=30173"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30173\/revisions"}],"predecessor-version":[{"id":30183,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30173\/revisions\/30183"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30174"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=30173"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=30173"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=30173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}