Beta-adrenoceptor antagonist.<\/p>\n
DEFINITION<\/h2>\n
Celiprolol Tablets contain Celiprolol Hydrochloride.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n
Content of celiprolol hydrochloride, C20<\/sub>H33<\/sub>N3<\/sub>O4<\/sub>,HCl\u00a0<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Mix with the aid of ultrasound a quantity of the powdered tablets containing 200 mg of Celiprolol Hydrochloride with 100 mL of dichloromethane for 30 minutes, filter (Whatman filter paper No. 42 is suitable), remove the dichloromethane using a rotary evaporator and dry the residue over phosphorus pentoxide at 110\u00b0 at a pressure not exceeding 2 kPa for 1 hour. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of celiprolol hydrochloride (RS 420).<\/p>\n Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n (a)\u2003Use Apparatus 2 rotating the paddle at 50 revolutions per minute.<\/p>\n (b)\u2003Use 900 mL of water at a temperature of 37\u00b0 as the medium.<\/p>\n (1)\u2003Withdraw a sample of 10 mL of the medium and filter; to 1 volume of the filtrate add sufficient water to produce 20 volumes and filter using a 0.45 \u00b5m membrane filter. Measure the absorbance of the filtrate, suitably diluted with water if necessary, at the maximum at 231 nm, Appendix II B, using water in the reference cell.<\/p>\n (2)\u2003Measure the absorbance of a 0.011% w\/v solution of celiprolol hydrochloride BPCRS in the dissolution medium at the maximum at 231 nm, Appendix II B, using water in the reference cell.<\/p>\n Calculate the total content of celiprolol hydrochloride, C20<\/sub>H33<\/sub>N3<\/sub>O4<\/sub>,HCl, in the medium using the declared content of C20<\/sub>H33<\/sub>N3<\/sub>O4<\/sub>,HCl in celiprolol hydrochloride BPCRS.<\/p>\n Carry out method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Disperse with the aid of ultrasound a quantity of the powdered tablets containing 0.1 g of Celiprolol Hydrochloride in 100 mL of the mobile phase for 15 minutes with occasional shaking, cool and filter using a 0.45-\u00b5m membrane filter. (2)\u2003Dilute 1 volume of solution (1) to 50 volumes with the mobile phase and further dilute 1 volume of this solution to 20 volumes with the mobile phase.<\/p>\n (3)\u2003Prepare a solution containing 0.1% w\/v of celiprolol hydrochloride BPCRS in water, add 5 drops of 5M sodium hydroxide and heat at 70\u00b0 for 20 minutes (generation of impurity A).<\/p>\n (a)\u2003Use a stainless steel column (30 cm \u00d7 3.9 mm) packed with octadecylsilyl silica gel for chromatography (10 \u00b5m) (Waters \u00b5Bondapak is suitable).<\/p>\n (b)\u2003Use isocratic elution and the mobile phase described below.<\/p>\n (c)\u2003Use a flow rate of 1.5 mL per minute.<\/p>\n (d)\u2003Use ambient column temperature.<\/p>\n (e)\u2003Use a detection wavelength of 233 nm.<\/p>\n (f)\u2003Inject 20 \u00b5L of each solution.<\/p>\n (g)\u2003For solution (1) allow the chromatography to proceed for twice the retention time of the principal peak.<\/p>\n A mixture of 25 volumes of acetonitrile and 75 volumes of 0.025M sodium dihydrogen phosphate monohydrate adjusted to pH 3.0 with 3M orthophosphoric acid. If necessary adjust the composition of the mobile phase so that, in the chromatogram obtained with solution (3), the peak due to celiprolol impurity A is resolved from the solvent front.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the peak due to celiprolol impurity A is resolved from the solvent front.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak due to celiprolol impurity A is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);<\/p>\n not more than one such peak has an area not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n the sum of the areas of any secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n Disregard any peak with an area of less than a fifth of the area of the peak in the chromatogram obtained with solution (2) (0.02%).<\/p>\n Carry out method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Disperse with the aid of ultrasound a quantity of the powdered tablets containing 0.1 g of Celiprolol Hydrochloride in 100 mL of the mobile phase for 15 minutes, cool and filter. Dilute 1 volume of the filtrate to 50 volumes with the mobile phase and filter using a 0.45 \u00b5m membrane filter.<\/p>\n (2)\u20030.002% w\/v solution of celiprolol hydrochloride BPCRS in the mobile phase.<\/p>\n The chromatographic conditions described under Related substances may be used.<\/p>\n Calculate the content of C20<\/sub>H33<\/sub>N3<\/sub>O4<\/sub>,HCl in the tablets using the declared content of C20<\/sub>H33<\/sub>N3<\/sub>O4<\/sub>,HCl in celiprolol hydrochloride BPCRS.<\/p>\n Celiprolol Tablets should be protected from light.<\/p>\n The impurities limited by the requirements of this monograph include those listed under Celiprolol Hydrochloride and the following:<\/p>\n Edition: BP 2025 (Ph. Eur. 11.6 update) Celiprolol Tablets General Notices Action and use\u00a0 Beta-adrenoceptor antagonist. DEFINITION Celiprolol Tablets contain Celiprolol Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of celiprolol hydrochloride, C20H33N3O4,HCl\u00a0 95.0 to 105.0% of the stated amount. IDENTIFICATION Mix with the aid of ultrasound…<\/p>\n","protected":false},"author":5,"featured_media":7957,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-7954","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\/7954","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=7954"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7954\/revisions"}],"predecessor-version":[{"id":8039,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7954\/revisions\/8039"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/7957"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=7954"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=7954"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=7954"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
TEST CONDITIONS<\/h4>\n
PROCEDURE<\/h4>\n
DETERMINATION OF CONTENT<\/h4>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"3-acetyl-4-{3-(1,1-dimethyl-ethylamino)-2-hydroxy}propoxybutyranilide\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Celiprolol-Tablets-1.jpg\")