Action and use<\/strong><\/p>\n Anticonvulsant; synaptic vesicle protein 2A (SV2A) ligand; adjunctive therapy of partial-onset seizures.<\/p>\n Ph Eur<\/p>\n Oral solution of Brivaracetam (3139), for human use.<\/p>\n It complies with the monograph Liquid preparations for oral use (0672) and the following additional requirements.<\/p>\n Content<\/strong><\/p>\n 95.0 per cent to 105.0 per cent of the content of brivaracetam (C11<\/sub>H20<\/sub>N2<\/sub>O2<\/sub>) stated on the label.<\/p>\n A. Examine the chromatograms obtained in the assay.<\/p>\n Results<\/em> The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (f).<\/p>\n B. Thin-layer chromatography (2.2.27).<\/p>\n Test solution<\/em> Extract 20 mL of the preparation to be examined with two quantities, each of 50 mL, of methylene chloride R. Filter the organic phase through a bed of anhydrous sodium sulfate R and evaporate to dryness in a water-bath at 50 \u00b0C. Dissolve the residue in 20 mL of methylene chloride R.<\/p>\n Reference solution<\/em> Dissolve 10 mg of brivaracetam CRS in 1 mL of methylene chloride R.<\/p>\n Plate<\/em> TLC silica gel F254 plate R (5-40 \u03bcm) [or TLC silica gel F254 plate R (2-10 \u03bcm)].<\/p>\n Mobile phase<\/em> concentrated ammonia R, methanol R, ethyl acetate R (3:12:85 V\/V\/V).<\/p>\n Application<\/em> 20 \u03bcL, as bands of 10 mm.<\/p>\n Development<\/em> Over 1\/2 of the plate.<\/p>\n Drying<\/em> In air for 1-2 min.<\/p>\n Detection<\/em> Expose to iodine vapour until the spots appear and examine in daylight.<\/p>\n Results<\/em> The relevant spot in the chromatogram obtained with the test solution is similar in position to the spot in the chromatogram obtained with the reference solution. Other spots may be present in the chromatogram obtained with the test solution.<\/p>\n Related substances<\/strong><\/p>\n Liquid chromatography (2.2.29).<\/p>\n Solvent mixture<\/em> acetonitrile R, water R (10:90 V\/V).<\/p>\n Test solution<\/em> Dilute a suitable volume of the preparation to be examined with the solvent mixture to obtain a concentration of brivaracetam of 0.20 mg\/mL.<\/p>\n Reference solution (a)<\/em> 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 Reference solution (b)<\/em> Dissolve 5 mg of brivaracetam impurity A CRS in the solvent mixture and dilute to 50 mL with the solvent mixture. Dissolve 4 mg of brivaracetam R in 1 mL of this solution and dilute to 20 mL with the solvent mixture.<\/p>\n Reference solution (c)<\/em> Dissolve 5 mg of brivaracetam impurity D CRS and 5 mg of brivaracetam impurity E CRS in the solvent mixture and dilute to 100 mL with the solvent mixture. Dilute 1 mL of this solution to 50 mL with the solvent mixture.<\/p>\n Reference solution (d)<\/em> Dissolve 24.0 mg of brivaracetam CRS in the solvent mixture and dilute to 100.0 mL with the solvent mixture.<\/p>\n Reference solutions (e), (f), (g), (h)<\/em> Dilute reference solution (d) with the solvent mixture as necessary to obtain reference solutions with a concentration of 0.22 mg\/mL, 0.20 mg\/mL (reference solution (f)), 0.18 mg\/mL and 0.16 mg\/mL.<\/p>\n Precolumn<\/em>:<\/p>\n \u2014 size<\/em>: l = 5 mm, \u00d8 = 2.1 mm;<\/p>\n \u2014 temperature<\/em>: 53 \u00b0C;<\/p>\n \u2014 stationary phase<\/em>: end-capped ethylene-bridged octadecylsilyl silica gel for chromatography (hybrid material) R (1.7 \u03bcm).<\/p>\n Column<\/em>:<\/p>\n \u2014 size<\/em>: l = 0.10 m, \u00d8 = 2.1 mm;<\/p>\n \u2014 temperature<\/em>: 53 \u00b0C;<\/p>\n \u2014 stationary phase<\/em>: end-capped ethylene-bridged octadecylsilyl silica gel for chromatography (hybrid material) R (1.7 \u03bcm).<\/p>\n Mobile phase<\/em>:<\/p>\n \u2014 mobile phase A<\/em>: formic acid R, water for chromatography R (0.1:1000 V\/V);<\/p>\n \u2014 mobile phase B<\/em>: formic acid R, acetonitrile R1 (0.1:1000 V\/V);<\/p>\n Flow rate<\/em> 0.4 mL\/min.<\/p>\n Detection<\/em> Spectrophotometer at 205 nm.<\/p>\n Injection<\/em> 3 \u03bcL of the test solution and reference solutions (a), (b) and (c).<\/p>\n Identification of impurities<\/em> Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A; use the chromatogram obtained with reference solution (c) to identify the peaks due to impurities D and E.<\/p>\n Relative retention<\/em> With reference to brivaracetam (retention time = about 8 min): impurity A = about 1.03; impurity D = about 1.26, impurity E = about 1.28.<\/p>\n System suitability<\/em> Reference solution (b):<\/p>\n \u2014 resolution<\/em> : minimum 2.0 between the peaks due to brivaracetam and impurity A.<\/p>\n Calculation of percentage contents<\/em>:<\/p>\n \u2014 for each impurity, use the concentration of brivaracetam in reference solution (a).<\/p>\n Limits<\/em>:<\/p>\n \u2014 sum of impurities D and E<\/em>: maximum 1.0 per cent;<\/p>\n \u2014 unspecified impurities<\/em>: for each impurity, maximum 0.20 per cent;<\/p>\n \u2014 total<\/em>: maximum 1.5 per cent;<\/p>\n \u2014 reporting threshold<\/em>: 0.10 per cent, disregard the peak due to impurity A.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances, with the following modifications.<\/p>\n Injection<\/em> Test solution and reference solutions (d), (e), (f), (g) and (h).<\/p>\n System suitability<\/em>:<\/p>\n \u2014 repeatability: maximum relative standard deviation of 1.0 per cent determined on 6 injections of reference solution (f);<\/p>\n \u2014 the coefficient of determination (r2<\/sup>) calculated for the calibration curve is not less than 0.995.<\/p>\n Calculate the percentage content of C11<\/sub>H20<\/sub>N2<\/sub>O2<\/sub> using the calibration curve and taking into account the assigned content of brivaracetam CRS.<\/p>\n Specified impurities D, E<\/em>.<\/p>\n Other detectable impurities<\/em> (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph): A.<\/p>\n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices (Ph. Eur. monograph 3141) Action and use Anticonvulsant; synaptic vesicle protein 2A (SV2A) ligand; adjunctive therapy of partial-onset seizures. Ph Eur DEFINITION Oral solution of Brivaracetam (3139), for human use. It complies with the monograph Liquid preparations for oral use (0672) and the following additional requirements….<\/p>\n","protected":false},"author":5,"featured_media":5541,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-5504","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\/5504","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=5504"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/5504\/revisions"}],"predecessor-version":[{"id":9192,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/5504\/revisions\/9192"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/5541"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=5504"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=5504"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=5504"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\n\n
\n Time
\n(min)<\/td>\nMobile phase A
\n(per cent V\/V)<\/td>\nMobile phase B
\n(per cent V\/V)<\/td>\n<\/tr>\n\n 0 – 1<\/td>\n 95<\/td>\n 5<\/td>\n<\/tr>\n \n 1 – 5<\/td>\n 95 \u2192 83<\/td>\n 5 \u2192 17<\/td>\n<\/tr>\n \n 5 – 13<\/td>\n 83 \u2192 70<\/td>\n 17 \u2192 30<\/td>\n<\/tr>\n \n 13 – 15<\/td>\n 70<\/td>\n 30<\/td>\n<\/tr>\n \n 15 – 15.5<\/td>\n 70 \u2192 25<\/td>\n 30 \u2192 75<\/td>\n<\/tr>\n \n 15.5 – 17<\/td>\n 25<\/td>\n 75<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n ASSAY<\/h2>\n
IMPURITIES<\/h2>\n
![\"\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Brivaracetam-Oral-Solution-1.jpg\")
\nA. (2S)-2-[(4S)-2-oxo-4-propylpyrrolidin-1-yl]butanamide,<\/p>\n![\"\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Brivaracetam-Oral-Solution-2.jpg\")
\nD. (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanoic acid,<\/p>\n![\"\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Brivaracetam-Oral-Solution-3.jpg\")
\nE. (2S)-2-[(4S)-2-oxo-4-propylpyrrolidin-1-yl]butanoic acid.<\/p>\n