{"id":14344,"date":"2025-10-15T10:44:42","date_gmt":"2025-10-15T03:44:42","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14344"},"modified":"2025-10-15T10:44:42","modified_gmt":"2025-10-15T03:44:42","slug":"flucloxacillin-infusion","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/flucloxacillin-infusion\/","title":{"rendered":"Flucloxacillin Infusion"},"content":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Penicillin antibacterial.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Flucloxacillin Infusion is a sterile solution containing Flucloxacillin Sodium Monohydrate and a suitable buffer. It is supplied as a ready-to-use solution.<br \/>\nThe infusion complies with the requirements stated under Parenteral Preparations and with the following requirements. Where appropriate, the infusion also complies with the requirements stated under Unlicensed Medicines.<\/p>\n<p><strong>Content of flucloxacillin, C<sub>19<\/sub>H<sub>17<\/sub>ClFN<sub>3<\/sub>O<sub>5<\/sub>S<\/strong><\/p>\n<p>90.0 to 105.0% of the stated amount.<\/p>\n<h2>CHARACTERS<\/h2>\n<p>A clear, colourless solution.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<br \/>\n(1) Dilute a volume of the infusion with sufficient phosphate buffer pH 7.0 to produce a solution containing the equivalent of 0.25% w\/v of flucloxacillin.<br \/>\n(2) 0.25% w\/v of flucloxacillin sodium BPCRS in phosphate buffer pH 7.0.<br \/>\n(3) 0.25% w\/v of each of cloxacillin sodium BPCRS, dicloxacillin sodium BPCRS and flucloxacillin sodium BPCRS in phosphate buffer pH 7.0.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a TLC silica gel silanised plate (Merck silanised silica gel 60 plates are suitable).<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 1 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 15 cm.<br \/>\n(e) After removal of the plate, allow it to dry in air, expose to iodine vapour until the spots appear and examine in<br \/>\ndaylight.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>30 volumes of acetone and 70 volumes of a 15.4% w\/v solution of ammonium acetate adjusted to pH 5.0 with glacial acetic acid.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows three clearly separated spots.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>The principal spot in the chromatogram obtained with solution (1) is similar in position, colour and size to that in the<br \/>\nchromatogram obtained with solution (2).<br \/>\nB. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of<br \/>\nthe principal peak in the chromatogram obtained with solution (2).TESTS<\/p>\n<p><strong>Acidity or alkalinity<\/strong><\/p>\n<p>pH, 5.5 to 7.5, Appendix V L.<\/p>\n<p><strong>Related substances<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<br \/>\n(1) Dilute a volume of the infusion with sufficient of the mobile phase to produce a solution containing the equivalent of<br \/>\n0.1% w\/v of flucloxacillin.<br \/>\n(2) Dilute 1 volume of solution (1) to 100 volumes with the mobile phase.<br \/>\n(3) Dilute 1 volume of solution (2) to 10 volumes with the mobile phase.<br \/>\n(4) 0.01% w\/v of each of cloxacillin sodium BPCRS and flucloxacillin sodium BPCRS in the mobile phase.<\/p>\n<p><strong>CHROMATOGRAPHIC CONDITIONS<\/strong><\/p>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil 5 ODS is suitable).<br \/>\n(b) Use isocratic elution and the mobile phase described below.<br \/>\n(c) Use a flow rate of 1 mL per minute.<br \/>\n(d) Use an ambient column temperature.<br \/>\n(e) Use a detection wavelength of 225 nm.<br \/>\n(f) Inject 20 \u03bcL of each solution.<br \/>\n(g) For solution (1), allow the chromatography to proceed for six times the retention time of the principal peak.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>25 volumes of acetonitrile and 75 volumes of a 0.27% w\/v solution of potassium dihydrogen orthophosphate adjusted to pH 5.0 with 2M sodium hydroxide.<br \/>\nWhen the chromatograms are recorded under the prescribed conditions, the retention time of flucloxacillin is about 12 minutes and the relative retention of cloxacillin is about 0.8.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to cloxacillin and flucloxacillin is at least 2.5.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1):<br \/>\nthe area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<br \/>\nthe sum of the areas of any secondary peaks is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (5%).<br \/>\nDisregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (3) (0.05%).<\/p>\n<p><strong>Bacterial endotoxins<\/strong><\/p>\n<p>Dilute the infusion with water BET to contain the equivalent of 9 mg of flucloxacillin per mL (solution A). The endotoxin limit concentration of solution A is 3.5 IU per mL, Appendix XIV C.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<br \/>\n(1) Dilute a volume of the infusion with sufficient of the mobile phase to produce a solution containing the equivalent of 0.1% w\/v of flucloxacillin; dilute 1 volume of the resulting solution to 10 volumes with the mobile phase.<br \/>\n(2) 0.011% w\/v of flucloxacillin sodium BPCRS in the mobile phase.<br \/>\n(3) 0.01% w\/v of each of cloxacillin sodium BPCRS and flucloxacillin sodium BPCRS in the mobile phase.<\/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 Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to\u00a0 cloxacillin and flucloxacillin is at least 2.5.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>19<\/sub>H<sub>17<\/sub>ClFN<sub>3<\/sub>O<sub>5<\/sub>S in the infusion using the declared content of C<sub>19<\/sub>H<sub>16<\/sub>ClFN<sub>3<\/sub>NaO<sub>5<\/sub>S in flucloxacillin sodium BPCRS. Each mg of C<sub>19<\/sub>H<sub>16<\/sub>ClFN<sub>3<\/sub>NaO<sub>5<\/sub>S is equivalent to 0.9538 mg of C<sub>19<\/sub>H<sub>17<\/sub>ClFN<sub>3<\/sub>O<sub>5<\/sub>S.<\/p>\n<h2>STORAGE<\/h2>\n<p>Flucloxacillin Infusion should be stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n<h2>LABELLING<\/h2>\n<p>The quantity of active ingredient is stated in terms of the equivalent amount of flucloxacillin.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BP 2025 (Ph. Eur. 11.6 update) Action and use Penicillin antibacterial. DEFINITION Flucloxacillin Infusion is a sterile solution containing Flucloxacillin Sodium Monohydrate and a suitable buffer. It is supplied as a ready-to-use solution. The infusion complies with the requirements stated under Parenteral Preparations and with the following requirements. Where appropriate, the infusion also complies with&#8230;<\/p>\n","protected":false},"author":5,"featured_media":14414,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14344","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14344","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=14344"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14344\/revisions"}],"predecessor-version":[{"id":14417,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14344\/revisions\/14417"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14414"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14344"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14344"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14344"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}