{"id":20699,"date":"2025-10-27T16:05:40","date_gmt":"2025-10-27T09:05:40","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20699"},"modified":"2025-10-27T16:05:40","modified_gmt":"2025-10-27T09:05:40","slug":"rifaximin-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/rifaximin-tablets\/","title":{"rendered":"Rifaximin Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Antibacterial; treatment of infective diarrhoea.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Rifaximin Tablets contain Rifaximin.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<h3>Content of rifaximin, C<sub>43<\/sub>H<sub>51<\/sub>N<sub>3<\/sub>O<sub>11<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 210 to 400 nm:<\/p>\n<p>the UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);<\/p>\n<p>the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n<p>(1) Disperse a quantity of the powdered tablets containing 0.25 g of Rifaximin with the mobile phase. Dilute to 50 mL and filter through a 0.45-\u03bcm filter (Whatman GF-C filter is suitable).<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n<p>(3) 0.125% w\/v of rifaximin for system suitability EPCRS.<\/p>\n<p>(4) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm x 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Alltima 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 1.4 mL per minute.<\/p>\n<p>(d) Use a column temperature of 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 276 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for 3 times the retention time of rifaximin.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>37 volumes of a 0.316% w\/v solution of ammonium formate, adjusted to pH 7.2 using dilute ammonia R1 and 63 volumes of a mixture of equal volumes of acetonitrile and methanol.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to rifaximin (retention time about 12 minutes) are: impurities D and H, about 0.7.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peak due to impurities D and H and the peak due to rifaximin is at least 3.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to impurities D and H is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<br \/>\nthe area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n<h4>Water<\/h4>\n<p>The tablets contain not more than 8.0% w\/w of water, Appendix IX C, Method I. Use 0.1 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n<p>(1) Shake a portion of the powdered tablets containing 0.5 g of Rifaximin with mobile phase and dilute to 100 mL. Filter, and dilute the filtrate to produce a solution containing 0.004% w\/v of Rifaximin.<\/p>\n<p>(2) 0.004% w\/v of rifaximin EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions under the Related substances may be used.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>43<\/sub>H<sub>51<\/sub>N<sub>3<\/sub>O<sub>11<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C<sub>43<\/sub>H<sub>51<\/sub>N<sub>3<\/sub>O<sub>11<\/sub> in rifaximin EPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Rifaximin.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Antibacterial; treatment of infective diarrhoea. DEFINITION Rifaximin Tablets contain Rifaximin. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of rifaximin, C43H51N3O11 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with&#8230;<\/p>\n","protected":false},"author":2,"featured_media":20713,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20699","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\/20699","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=20699"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20699\/revisions"}],"predecessor-version":[{"id":20715,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20699\/revisions\/20715"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20713"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20699"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20699"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20699"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}