Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Non-depolarizing neuromuscular blocker.<\/p>\n Preparation<\/strong><\/p>\n Vecuronium Bromide for Injection Ph Eur<\/p>\n 1-[3\u03b1,17\u03b2-Bis(acetyloxy)-2\u03b2-(piperidin-1-yl)-5\u03b1-androstan-16\u03b2-yl]-1-methylpiperidin-1-ium\u00a0 bromide.<\/p>\n Content<\/strong><\/p>\n 99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n White or almost white crystals or crystalline powder.<\/p>\n Slightly soluble in water, freely soluble in methylene chloride, sparingly soluble in acetonitrile and in anhydrous ethanol.<\/p>\n A. Specific optical rotation (see Tests).<\/p>\n B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 vecuronium bromide CRS.<\/p>\n C. It gives reaction (a) of bromides (2.3.1).<\/p>\n Dissolve 0.500 g in a 5.15 g\/L solution of hydrochloric acid R and dilute to 50.0 mL with the same solution.<\/p>\n Solution S is clear (2.2.1) and not more intensely coloured than reference solution BY7 (2.2.2, Method II).<\/p>\n Specific optical rotation (2.2.7)<\/strong><\/p>\n + 30.5 to + 35.0 (anhydrous substance), determined on solution S.<\/p>\n Thin-layer chromatography (2.2.27).<\/p>\n Test solution Dissolve 0.10 g of the substance to be examined in methylene chloride R and dilute to 5.0 mL with the same solvent.<\/p>\n Reference solution (a)\u00a0 Dissolve 5 mg of the substance to be examined and 5 mg of pancuronium bromide CRS (impurity B) in methylene chloride R and dilute to 5.0 mL with the same solvent.<\/p>\n Reference solution (b)\u00a0 Dissolve 5.0 mg of pancuronium bromide CRS (impurity B) in methylene chloride R and dilute to 100.0 mL with the same solvent.<\/p>\n Plate\u00a0 TLC silica gel plate R (2-10 \u00b5m).<\/p>\n Mobile phase\u00a0 Dissolve 1 g of sodium bromide R in 5 mL of water R. Add 85 mL of 2-propanol R, then 10 mL of acetonitrile R. Application 1 \u00b5L.<\/p>\n Development\u00a0 In an unsaturated tank, over 2\/3 of the plate.<\/p>\n Drying\u00a0 In air for 30 min.<\/p>\n Detection Spray with a 2.5 g\/L solution of iodine R in a mixture of equal volumes of methanol R and methylene chloride R.<\/p>\n System suitability\u00a0 Reference solution (a):<\/p>\n \u2014 the chromatogram shows 2 clearly separated spots.<\/p>\n Limit:<\/p>\n \u2014 impurity B: any spot due to impurity B is not more intense than the spot in the chromatogram obtained with reference solution (b) (0.25 per cent).<\/p>\n Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Solution A 0.2 g\/L solution of hydrochloric acid R in methanol R2.<\/p>\n Test solution\u00a0 Dissolve 40 mg of the substance to be examined in solution A and dilute to 20.0 mL with solution A.<\/p>\n Reference solution (a) Dissolve 4 mg of vecuronium for system suitability CRS (containing impurities C and E) in solution A and dilute to 2.0 mL with the solution A.<\/p>\n Reference solution (b)\u00a0 Dilute 1.0 mL of the test solution to 100.0 mL with solution A. Dilute 1.0 mL of this solution to 10.0 mL with solution A.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m);<\/p>\n \u2014 temperature: 40 \u00b0C.<\/p>\n Mobile phase Mix 135 volumes of an 18.0 g\/L solution of tetramethylammonium hydroxide R previously adjusted to pH 6.9 with phosphoric acid R, 250 volumes of methanol R2 and 615 volumes of acetonitrile R1.<\/p>\n Flow rate\u00a0 2.0 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 210 nm.<\/p>\n Autosampler\u00a0 Set at 4 \u00b0C.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n Run time\u00a0 5 times the retention time of vecuronium.<\/p>\n Identification of impurities Use the chromatogram supplied with vecuronium for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities C and E.<\/p>\n Relative retention With reference to vecuronium (retention time = about 5 min): impurity C = about 0.8; impurity E = about 1.2.<\/p>\n System suitability:<\/p>\n \u2014 signal-to-noise ratio: minimum 28 for the principal peak in the chromatogram obtained with reference solution (b);<\/p>\n \u2014 peak-to-valley ratio: minimum 2.0, where Hp = height above the baseline of the peak due to impurity E and<\/p>\n Hv = height above the baseline of the lowest point of the curve separating this peak from the principal peak in the chromatogram obtained with reference solution (a).<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factor: multiply the peak area of impurity C by 1.4;<\/p>\n \u2014 for each impurity, use the concentration of vecuronium bromide in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 impurity C: maximum 0.15 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.2 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Water (2.5.12)<\/strong><\/p>\n Maximum 4.0 per cent, determined on 0.300 g.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.450 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n 1 mL of 0.1 M perchloric acid is equivalent to 63.8 mg of C34<\/sub>H57<\/sub>BrN2<\/sub>O4<\/sub>.<\/p>\n In an airtight container, protected from light and moisture.<\/p>\n Specified impurities\u00a0 B, C.<\/em><\/p>\n Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, D, E, F.<\/em><\/p>\n A. 2\u03b2,16\u03b2-di(piperidin-1-yl)-5\u03b1-androstane-3\u03b1,17\u03b2-diyl diacetate,<\/p>\n B. 1,1\u2032-[3\u03b1,17\u03b2-bis(acetyloxy)-5\u03b1-androstane-2\u03b2,16\u03b2-diyl]bis(1-methylpiperidin-1-ium)\u00a0 (pancuronium),<\/p>\n C. 1-[17\u03b2-(acetyloxy)-3\u03b1-hydroxy-2\u03b2-(piperidin-1-yl)-5\u03b1-androstan-16\u03b2-yl]-1-methylpiperidin-1-ium,<\/p>\n D. 1-[3\u03b1,17\u03b2-dihydroxy-2\u03b2-(piperidin-1-yl)-5\u03b1-androstan-16\u03b2-yl]-1-methylpiperidin-1-ium,<\/p>\n E. 1-[3\u03b1-(acetyloxy)-17\u03b2-hydroxy-2\u03b2-(piperidin-1-yl)-5\u03b1-androstan-16\u03b2-yl]-1-methylpiperidin-1-ium,<\/p>\n F. 2\u03b2-(piperidin-1-yl)-17-oxo-5\u03b1-androstan-3\u03b1-yl acetate.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Non-depolarizing neuromuscular blocker. Preparation Vecuronium Bromide for Injection Ph Eur DEFINITION 1-[3\u03b1,17\u03b2-Bis(acetyloxy)-2\u03b2-(piperidin-1-yl)-5\u03b1-androstan-16\u03b2-yl]-1-methylpiperidin-1-ium\u00a0 bromide. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white crystals or crystalline powder. Solubility Slightly soluble in water, freely soluble in methylene chloride, sparingly soluble…<\/p>\n","protected":false},"author":5,"featured_media":31051,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31050","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31050","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=31050"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31050\/revisions"}],"predecessor-version":[{"id":31060,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31050\/revisions\/31060"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31051"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Impurity B<\/h3>\n
Related substances<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n