{"id":23184,"date":"2025-10-31T14:43:28","date_gmt":"2025-10-31T07:43:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=23184"},"modified":"2025-10-31T14:43:28","modified_gmt":"2025-10-31T07:43:28","slug":"enrofloxacin-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/enrofloxacin-tablets\/","title":{"rendered":"Enrofloxacin Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Fluoroquinolone antibacterial.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Enrofloxacin Tablets contain Enrofloxacin.<\/p>\n<p>The tablets complies with the requirements stated under Tablets and with the following requirements.<\/p>\n<h3>Content of enrofloxacin, C<sub>19<\/sub>H<sub>22<\/sub>FN<sub>3<\/sub>O<sub>3<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. To a quantity of the powdered tablets containing 0.1 g of Enrofloxacin, add 10 mL of dichloromethane, shake and filter. Wash the filtrate with three 20-mL quantities of water. Dry the washed dichloromethane with sodium sulfate, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of enrofloxacin (RSV 55).<\/p>\n<p>B. In the Assay, 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>Dissolution<\/h3>\n<p>Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n<p>TEST CONDITIONS<\/p>\n<p>(a) Use Apparatus 2, rotating the paddle at 100 revolutions per minute.<\/p>\n<p>(b) Use 900 mL of a solution containing 2.1% w\/v citric acid monohydrate in 0.2M sodium hydroxide, adjusted to pH 4.0 with 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n<p>PROCEDURE<\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) After 30 minutes withdraw a sample of the medium and filter (a 0.45-\u03bcm cellulose filter is suitable). Dilute the filtrate with dissolution medium, if necessary, to produce a solution expected to contain 0.0015% w\/v of Enrofloxacin.<\/p>\n<p>(2) 0.0015% w\/v of enrofloxacin BPCRS in 0.1M formic acid.<\/p>\n<p>(3) 0.05% w\/v of enrofloxacin BPCRS and 0.0005% w\/v of ciprofloxacin hydrochloride BPCRS (impurity B).<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.0 mm) packed with octadecylsilyl silica gel for chromatography (10 \u03bcm) (Nucleosil RP18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2.0 mL per minute.<\/p>\n<p>(d) Use a column temperature of 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 278 nm.<\/p>\n<p>(f) Inject 5 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>100 volumes of a solution containing 1.1% w\/v of sodium heptanesulfonate monohydrate and 2.72% w\/v of potassium dihydrogen orthophosphate, 240 volumes of acetonitrile and 660 volumes of water, adjust the pH of the mixture to 2.1 with orthophosphoric acid.<\/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 peaks corresponding to impurity B and enrofloxacin is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the total content of enrofloxacin, C<sub>19<\/sub>H<sub>22<\/sub>FN<sub>3<\/sub>O<sub>3<\/sub>, in the medium from the chromatograms obtained and using the declared content of C<sub>19<\/sub>H<sub>22<\/sub>FN<sub>3<\/sub>O<sub>3<\/sub> in enrofloxacin BPCRS.<\/p>\n<p>LIMITS<\/p>\n<p>The amount of enrofloxacin released is not less than 75% (Q) of the stated amount.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in a solution containing 1 volume of acetonitrile and 3 volumes of 0.1M formic acid.<\/p>\n<p>(1) Dissolve a quantity of the powdered tablets containing 50 mg of Enrofloxacin in the solvent mixture, dilute to 100 mL and filter (a 0.45-\u03bcm cellulose filter is suitable)<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n<p>(3) 0.05% w\/v of enrofloxacin BPCRS and 0.0005% w\/v of ciprofloxacin hydrochloride BPCRS (impurity B).<\/p>\n<p>(4) Dilute 3 volumes of solution (2) to 10 volumes.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under dissolution may be used with the following mobile phase and allowing the chromatography to proceed for twice the retention time of enrofloxacin.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>100 volumes of a solution containing 1.1% w\/v of sodium heptanesulfonate monohydrate and 2.72% w\/v of potassium dihydrogen orthophosphate, 230 volumes of acetonitrile and 670 volumes of water adjusted to pH 2.1 with orthophosphoric acid.<\/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 peaks corresponding to impurity B and enrofloxacin is at least 2.0.<\/p>\n<p>CALCULATION OF IMPURITIES<\/p>\n<p>For each impurity, use the concentration of enrofloxacin in solution (2).<\/p>\n<p>For the reporting threshold, use the concentration of enrofloxacin in solution (4).<\/p>\n<p>For peak identification, use solution (3).<\/p>\n<p>Enrofloxacin retention time: about 6 minutes.<\/p>\n<p>Relative retention: impurity B, about 0.7.<\/p>\n<p>LIMITS<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than 1.0%;<\/p>\n<p>\u2014 total impurities: not more than 2.0%;<\/p>\n<p>\u2014 reporting threshold: 0.3%.<\/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 prepared in a solution containing 1 volume of acetonitrile and 3 volumes of 0.1M formic acid.<\/p>\n<p>(1) Disperse a quantity of the powdered tablets containing 50 mg of Enrofloxacin in the solvent mixture, dilute to 100 mL and filter (a 0.45-\u03bcm cellulose filter is suitable).<\/p>\n<p>(2) 0.05% w\/v of enrofloxacin BPCRS.<\/p>\n<p>(3) 0.05% w\/v of enrofloxacin BPCRS and 0.0005% w\/v of ciprofloxacin hydrochloride BPCRS (impurity B).<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under Related substances may be used.<\/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 peaks corresponding to impurity B and enrofloxacin is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>19<\/sub>H<sub>22<\/sub>FN<sub>3<\/sub>O<sub>3<\/sub> in the tablets from the chromatograms obtained and using the declared content of C<sub>19<\/sub>H<sub>22<\/sub>FN<sub>3<\/sub>O<sub>3<\/sub> in enrofloxacin BPCRS.<\/p>\n<h3>IMPURITIES<\/h3>\n<p>The impurities limited by the requirements of this monograph include impurity B listed under Enrofloxacin.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Fluoroquinolone antibacterial. DEFINITION Enrofloxacin Tablets contain Enrofloxacin. The tablets complies with the requirements stated under Tablets and with the following requirements. Content of enrofloxacin, C19H22FN3O3 95.0 to 105.0% of the stated amount. IDENTIFICATION A. To a quantity of the powdered tablets containing 0.1 g of Enrofloxacin, add 10 mL of dichloromethane, shake&#8230;<\/p>\n","protected":false},"author":2,"featured_media":23203,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-23184","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23184","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=23184"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23184\/revisions"}],"predecessor-version":[{"id":23207,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23184\/revisions\/23207"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23203"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}