Treatment of coccidiosis; antiprotozoal (veterinary).<\/p>\n
DEFINITION<\/h2>\n
(2RS)-[2-Chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-2(3H)-yl)phenyl](4-chlorophenyl)acetonitrile.<\/p>\n
Content<\/strong><\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n Appearance<\/strong><\/p>\n White or light yellow powder.<\/p>\n Solubility<\/strong><\/p>\n Practically insoluble in water, freely soluble in dimethylformamide, slightly soluble in ethanol (96 per cent) and in methylene chloride.<\/p>\n A. Melting point (2.2.14): 199 \u00b0C to 203 \u00b0C.<\/p>\n B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 clazuril CRS.<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Solvent mixture<\/em>\u00a0 tetrahydrofuran R, water R (50:50 V\/V).<\/p>\n Test solution<\/em> Dissolve 20.0 mg of the substance to be examined in the solvent mixture and dilute to 20.0 mL with the solvent mixture.<\/p>\n Reference solution<\/em> (a) Dissolve 5 mg of clazuril for system suitability CRS (containing impurities A, B, C, D, E, F, G, H and I) in the solvent mixture and dilute to 5.0 mL with the solvent mixture.<\/p>\n Reference solution<\/em> (b) Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 2.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n Column:<\/em><\/p>\n \u2014 size: l<\/em> = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase:<\/em> octadecylsilyl silica gel for chromatography R (3 \u00b5m);<\/p>\n \u2014 temperature:<\/em> 35 \u00b0C.<\/p>\n Mobile phase<\/em>:<\/p>\n \u2014 mobile phase A<\/em>: mix 100 volumes of a 7.7 g\/L solution of ammonium acetate R adjusted to pH 6.2 with a 10 per cent V\/V solution of anhydrous formic acid R, 150 volumes of acetonitrile R and 750 volumes of water R;<\/p>\n \u2014 mobile phase B<\/em>: mix 50 volumes of water R, 100 volumes of a 7.7 g\/L solution of ammonium acetate R adjusted to pH 6.2 with a 10 per cent V\/V solution of anhydrous formic acid R and 850 volumes of acetonitrile R;<\/p>\n Flow rate\u00a0<\/em> 1.0 mL\/min.<\/p>\n Detection<\/em>\u00a0 Spectrophotometer at 230 nm.<\/p>\n Injection<\/em>\u00a0 5 \u00b5L.<\/p>\n Identification of impurities<\/em> Use the chromatogram supplied with clazuril for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B, C, D, E, F, G, H and I.<\/p>\n Relative retention<\/em> With reference to clazuril (retention time = about 16 min): impurity A = about 0.6; impurity B = about 0.78; impurity C = about 0.80; impurity D = about 0.86; impurity E = about 0.9; impurity F = about 0.95; impurity G = about 0.98; impurity H = about 1.1; impurity I = about 1.2.<\/p>\n System suitability<\/em>\u00a0 Reference solution (a):<\/p>\n \u2014 peak-to-valley ratio:<\/em> minimum 1.5, where Hp = height above the baseline of the peak due to impurity G and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to clazuril,<\/p>\n \u2014 the chromatogram obtained is similar to the chromatogram supplied with clazuril for system suitability CRS.<\/p>\n Limits:<\/em><\/p>\n \u2014 correction factors:<\/em> for the calculation of contents, multiply the peak areas of the following impurities by the corresponding correction factor: impurity G = 1.4; impurity H = 0.8;<\/p>\n \u2014 impurities A, B, C, D, E, F, G, H, I:<\/em> for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n \u2014 unspecified impurities:<\/em> for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.20 per cent);<\/p>\n \u2014 total:<\/em> not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.6 per cent);<\/p>\n \u2014 disregard limit:<\/em> 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent); disregard the peaks due to the solvents.<\/p>\n Loss on drying (2.2.32)<\/strong><\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 4 h.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve about 0.260 g in 35 mL of tetrahydrofuran R and add 35 mL of water R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20). Carry out a blank titration.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 37.32 mg of C17H10Cl2N4O2.<\/p>\n Protected from light.<\/p>\n Specified impurities\u00a0 A, B, C, D, E, F, G, H, I.<\/p>\n A. (2RS)-[2-chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-2(3H)-yl)phenyl](4-chlorophenyl)acetic acid,<\/p>\n B. 2-[3-chloro-4-[(RS)-(4-chlorophenyl)cyanomethyl]phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carboxamide,<\/p>\n C. (2RS)-2-[2-chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-2(3H)-yl)phenyl]-2-(4-chlorophenyl)acetamide,<\/p>\n D. 2-[3-chloro-4-[(RS)-(4-chlorophenyl)cyanomethyl]phenyl]-N,N-dimethyl-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6- carboxamide,<\/p>\n E. methyl 2-[3-chloro-4-[(RS)-(4-chlorophenyl)cyanomethyl]phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6- carboxylate,<\/p>\n F. ethyl 2-[3-chloro-4-[(RS)-(4-chlorophenyl)cyanomethyl]phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6- carboxylate,<\/p>\n G. 2-[3-chloro-4-(4-chlorobenzoyl)phenyl]-1,2,4-triazine3,5(2H,4H)-dione,<\/p>\n H. [2-chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-2(3H)-yl)phenyl][4-[[2-chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-\u00a0 2(3H)-yl)phenyl]cyanomethyl]phenyl](4-chlorophenyl)acetonitrile,<\/p>\n I. (Z)-2-[[3-chloro-4-[(RS)-(4-chlorophenyl)cyanomethyl]phenyl]diazanylidene]acetamide.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Treatment of coccidiosis; antiprotozoal (veterinary). DEFINITION (2RS)-[2-Chloro-4-(3,5-dioxo-4,5-dihydro-1,2,4-triazin-2(3H)-yl)phenyl](4-chlorophenyl)acetonitrile. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or light yellow powder. Solubility Practically insoluble in water, freely soluble in dimethylformamide, slightly soluble in ethanol (96 per cent) and in methylene chloride. IDENTIFICATION…<\/p>\n","protected":false},"author":5,"featured_media":22835,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22834","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\/22834","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=22834"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22834\/revisions"}],"predecessor-version":[{"id":22910,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22834\/revisions\/22910"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22835"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\n\n
\n Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n \n 0-20<\/td>\n 100 \u2192 0<\/td>\n 0 \u2192 100<\/td>\n<\/tr>\n \n 20-25<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-1.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-2.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-3.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-4.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-5.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-6.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-7.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-8.jpg\")
<\/p>\n![\"Clazuril\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Clazuril-British-Pharmacopoeia-2025-9.jpg\")
<\/p>\n