{"id":23666,"date":"2025-11-01T09:00:28","date_gmt":"2025-11-01T02:00:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=23666"},"modified":"2025-11-01T09:00:28","modified_gmt":"2025-11-01T02:00:28","slug":"ketoprofen-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ketoprofen-tablets\/","title":{"rendered":"Ketoprofen Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Ketoprofen Tablets contain Ketoprofen.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<h3>Content of ketoprofen, C<sub>16<\/sub>H<sub>14<\/sub>O<sub>3<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Shake a quantity of powdered tablets containing 40 mg of Ketoprofen with 10 mL of dichloromethane. Filter and evaporate the solution to dryness under nitrogen. Dry the residue at 60\u00b0 for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ketoprofen (RSV 053).<\/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, and rotate the paddle at 50 revolutions per minute.<\/p>\n<p>(b) Use 900 mL of a phosphate buffer prepared by dissolving 1.46 g of potassium dihydrogen orthophosphate and 20.06 g of disodium hydrogen orthophosphate in sufficient water to produce 1000 mL, adjusting the pH to 7.5 if necessary with orthophosphoric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n<p>PROCEDURE<\/p>\n<p>After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample, diluted with dissolution medium if necessary, to produce a solution expected to contain 0.00055% w\/v of Ketoprofen, at the maximum at 260 nm, Appendix II B, using dissolution medium in the reference cell.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the total content of ketoprofen, C16H14O3, in the medium taking 662 as the value of A(1%, 1 cm) at the maximum at 260 nm.<\/p>\n<p>LIMITS<\/p>\n<p>The amount of ketoprofen 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 immediately before use in mobile phase.<\/p>\n<p>(1) Shake a quantity of the powdered tablets containing 25 mg of Ketoprofen with 20 mL, mix with the aid of ultrasound and dilute to 25 mL. Filter and use the filtrate.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes. Further dilute 1 volume to 5 volumes.<\/p>\n<p>(3) 0.0002% w\/v of ketoprofen impurity A EPCRS.<\/p>\n<p>(4) 0.0002% w\/v of ketoprofen impurity C EPCRS.<\/p>\n<p>(5) 0.0005% w\/v of ketoprofen BPCRS and 0.0001% w\/v of ketoprofen impurity A EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) with a specific surface area of 350 m<sup>2<\/sup> \/g and a pore size of 10 nm (Nucleosil 100 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 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 233 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for 7 times the retention time of ketoprofen.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>2 volumes of freshly prepared phosphate buffer solution pH 3.5, 43 volumes of acetonitrile and 55 volumes of water.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to ketoprofen (retention time about 8. minutes) are: impurity C, about 0.3; impurity E, about 0.7; impurity B, about 0.8; impurity D, about 1.5; impurity A, about 1.6; impurity F, about 2.2.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to ketoprofen and impurity A is at least 7.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>Use the chromatogram obtained with solution (3) to identify the peak due to impurity A; use the chromatogram obtained with solution (4) to identify the peak due to impurity C. the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n<p>the area of any peak corresponding to impurity C is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);<\/p>\n<p>the area of any peak corresponding to impurity B, D, E or F is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2% of each);<\/p>\n<p>the area of any other secondary peak is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n<p>the sum of the areas of all the secondary peaks excluding impurities A and C is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.4%).<\/p>\n<p>Disregard any peak (excluding impurities A, B, C, D, E and F) with an area less than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (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 in mobile phase.<\/p>\n<p>(1) Shake a quantity of the powdered tablets containing 20 mg of Ketoprofen in mobile phase, mix with the aid of ultrasound and dilute to 25 mL. Dilute 1 volume to 100 volumes, filter and use the filtrate.<\/p>\n<p>(2) 0.001% w\/v of ketoprofen BPCRS.<\/p>\n<p>(3) 0.0005% w\/v ketoprofen BPCRS and 0.0001% w\/v ketoprofen impurity A EPCRS.<\/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 due to ketoprofen and impurity A is at least 7.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>16<\/sub>H<sub>14<\/sub>O<sub>3<\/sub>3 in the tablets using the declared content of C<sub>16<\/sub>H<sub>14<\/sub>O<sub>3<\/sub> in ketoprofen BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Ketoprofen.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. DEFINITION Ketoprofen Tablets contain Ketoprofen. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of ketoprofen, C16H14O3 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of powdered tablets containing 40 mg of Ketoprofen with 10 mL of dichloromethane. Filter&#8230;<\/p>\n","protected":false},"author":2,"featured_media":23675,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-23666","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\/23666","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=23666"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23666\/revisions"}],"predecessor-version":[{"id":23678,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23666\/revisions\/23678"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/23675"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23666"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23666"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23666"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}