Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Histamine H1 receptor antagonist; antihistamine.<\/p>\n Cyclizine Tablets contain Cyclizine Hydrochloride.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of cyclizine hydrochloride, C18<\/sub>H22<\/sub>N2<\/sub>,HCl<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. Extract a quantity of the powdered tablets containing 0.1 g of Cyclizine Hydrochloride with 10 mL of ethanol (96%), filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of Cyclizine Hydrochloride (RS 076).<\/p>\n B. Extract a quantity of the powdered tablets containing 0.5 g of Cyclizine Hydrochloride with 20 mL of water and filter. The filtrate yields reaction A characteristic of chlorides, Appendix VI.<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for gas chromatography, Appendix III B, using the following solutions prepared immediately before use.<\/p>\n (1) Triturate a quantity of the powdered tablets containing 0.20 g of Cyclizine Hydrochloride with 8 mL of methanol, add 2 mL of 1M sodium hydroxide and filter. Dilute 1 volume of the resulting solution to 4 volumes with methanol.<\/p>\n (2) Dilute 1 volume of solution (1) to 100 volumes with methanol and dilute 1 volume of the resulting solution to 5 volumes with methanol.<\/p>\n (3) 0.0025% w\/v of cyclizine hydrochloride BPCRS, 0.0025% w\/v of 1-methylpiperazine BPCRS (impurity A) and 0.0025% w\/v of diphenylmethanol BPCRS (impurity B) in methanol.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/strong><\/p>\n (a) Use a fused silica column (25 m \u00d7 0.33 mm) coated with a 0.5-\u03bcm film of phenyl(5)methyl(95)polysiloxane (HP-5 is suitable).<\/p>\n (b) Use helium as the carrier gas with a constant flow rate of 1 mL per minute.<\/p>\n (c) Use the gradient system described below.<\/p>\n (d) Use a split injection ratio of 1:25.<\/p>\n (e) Use a flame ionisation detector at 290\u00b0.<\/p>\n (f) Inject 1 \u03bcL of each solution.<\/p>\n (g) The peaks elute in the order: methanol, 1-methylpiperazine, diphenylmethanol, cyclizine.<\/p>\n SYSTEM SUITABILITY<\/strong><\/p>\n Inject solution (3) six times. The relative standard deviation of each of the areas of the three principal peaks is not more than 5.0%.<\/p>\n The test is not valid unless in the chromatogram obtained with solution (3);<\/p>\n the peak-to-valley ratio between methanol and 1-methylpiperazine is at least 50;<\/p>\n the resolution factor between diphenylmethanol and cyclizine is at least 18.<\/p>\n LIMITS<\/strong><\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to 1-methylpiperazine (impurity A) is not greater than the peak corresponding to 1-methylpiperazine in solution (3) (0.5%);<\/p>\n the area of any peak corresponding to diphenylmethanol (impurity B) is not greater than the peak corresponding to diphenylmethanol in solution (3) (0.5%);<\/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) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n Disregard any peak with an area less than 0.5 times that of the peak due to cyclizine in the chromatogram obtained with solution (2) (0.1%).<\/p>\n Weigh and powder 20 tablets. Shake a quantity of the powder containing 0.125 g of Cyclizine Hydrochloride with 400 mL of 0.05M sulfuric acid for 15 minutes. Add sufficient 0.05M sulfuric acid to produce 500 mL, filter, dilute 5 mL of the filtrate to 100 mL with 0.05M sulfuric acid and measure the absorbance of the resulting solution at the maximum at 225 nm, Appendix II B. Calculate the content of C18<\/sub>H22<\/sub>N,HCl taking 390 as the value of A(1%, 1 cm) at the maximum at 225 nm.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Histamine H1 receptor antagonist; antihistamine. DEFINITION Cyclizine Tablets contain Cyclizine Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of cyclizine hydrochloride, C18H22N2,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Extract a quantity of the powdered…<\/p>\n","protected":false},"author":5,"featured_media":10991,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-10988","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\/10988","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=10988"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10988\/revisions"}],"predecessor-version":[{"id":10995,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10988\/revisions\/10995"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10991"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10988"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10988"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\n\n
\n \nTime (minutes)<\/th>\n Temperature<\/th>\n Comment<\/th>\n<\/tr>\n<\/thead>\n \n 0 \u2192 14<\/td>\n 100\u00b0 \u2192 240\u00b0<\/td>\n Linear gradient<\/td>\n<\/tr>\n \n 14 \u2192 16<\/td>\n 240\u00b0 \u2192 270\u00b0<\/td>\n Linear gradient<\/td>\n<\/tr>\n \n 16 \u2192 30<\/td>\n 270\u00b0<\/td>\n Isocratic<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n ASSAY<\/h2>\n