Action and use<\/strong><\/p>\n Aid to smoking cessation.<\/p>\n 3-[(2S)-1-Methylpyrrolidin-2-yl]pyridine bis[(2R,3R)-2,3-dihydroxybutanedioate] dihydrate.<\/p>\n 98.5 per cent to 101.5 per cent (anhydrous substance).<\/p>\n White or almost white powder.<\/p>\n Soluble in water and in ethanol (96 per cent).<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: nicotine ditartrate dihydrate CRS.<\/p>\n 3.0 to 3.4.<\/p>\n Dissolve 1.0 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n + 21.0 to + 23.0.<\/p>\n Dissolve 0.25 g in water R and dilute to 25.0 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n Test solution: Dissolve 60 mg of the substance to be examined in water R and dilute to 25.0 mL with the same solvent.<\/p>\n Reference solution (a): Dissolve the contents of a vial of nicotine for system suitability CRS (containing impurities A, B, C, D, E, F and G) in 1.0 mL of water R. Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped polar-embedded octadecylsilyl amorphous organosilica polymer R (5 \u03bcm).<\/p>\n Mobile phase:<\/p>\n \u2014 mobile phase A: to 900 mL of water R add 25 mL of a 60 g\/L solution of acetic acid R and 6 mL of concentrated ammonia R1; adjust to pH 10.0 with dilute ammonia R2 or dilute acetic acid R and dilute to 1000.0 mL with water R;<\/p>\n \u2014 mobile phase B: acetonitrile R;<\/p>\n Flow rate: 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 254 nm.<\/p>\n Injection: 20 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram supplied with nicotine 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 and G.<\/p>\n Relative retention: With reference to nicotine (retention time = about 17.8 min): impurity E = about 0.3; impurity C = about 0.55; impurity F = about 0.7; impurity A = about 0.8; impurity D = about 0.86; impurity G = about 0.9; impurity B = about 1.6.<\/p>\n System suitability: Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.5 between the peaks due to impurity G and nicotine.<\/p>\n Limits:<\/p>\n \u2014 impurities A, B, C, D, E, F, G: for each impurity, not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n \u2014 total: not more than 8 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.8 per cent);<\/p>\n \u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n 6.5 per cent to 8.0 per cent, determined on 0.100 g.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.180 g in 50 mL of anhydrous 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 23.12 mg of C18<\/sub>H26<\/sub>N2<\/sub>O12<\/sub>.<\/p>\n Protected from light.<\/p>\n Specified impurities A, B, C, D, E, F, G.<\/p>\n A. (2S)-1,2,3,6-tetrahydro-2,3\u2032-bipyridyl (anatabine),<\/p>\n B. 3-(1-methyl-1H-pyrrol-2-yl)pyridine (\u03b2-nicotyrine),<\/p>\n C. (5S)-1-methyl-5-(pyridin-3-yl)pyrrolidin-2-one (cotinine),<\/p>\n D. 3-(4,5-dihydro-3H-pyrrol-2-yl)pyridine (myosmine),<\/p>\n E. (1RS,2S)-1-methyl-2-(pyridin-3-yl)pyrrolidine 1-oxide (nicotine N\u2032-oxide),<\/p>\n F. 3-[(2S)-pyrrolidin-2-yl]pyridine (nornicotine),<\/p>\n G. 3-[(2S)-piperidin-2-yl]pyridine (anabasine).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 2599) C18H26N2O12,2H2O\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 498.4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a06019-06-3 Action and use Aid to smoking cessation. DEFINITION 3-[(2S)-1-Methylpyrrolidin-2-yl]pyridine bis[(2R,3R)-2,3-dihydroxybutanedioate] dihydrate. Content 98.5 per cent to 101.5 per cent (anhydrous substance). CHARACTERS Appearance White or almost white powder. Solubility Soluble in water and in ethanol (96 per…<\/p>\n","protected":false},"author":2,"featured_media":25278,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25264","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\/25264","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=25264"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25264\/revisions"}],"predecessor-version":[{"id":25326,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25264\/revisions\/25326"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25278"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
pH (2.2.3)<\/h4>\n
Specific optical rotation (2.2.7)<\/h4>\n
Related substances<\/h3>\n
\nReference solution (b) Dilute 1.0 mL of the test solution to 100.0 mL with water R. Dilute 1.0 mL of this solution to 10.0 mL with water R.<\/p>\n\n\n
\n Time<\/strong>
\n(min)<\/strong><\/td>\nMobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\nMobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n\n 0 – 3<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n \n 3 – 3.01<\/td>\n 100 \u2192 95<\/td>\n 0 \u2192 5<\/td>\n<\/tr>\n \n 3.01 – 28<\/td>\n 95 \u2192 74<\/td>\n 5 \u2192 26<\/td>\n<\/tr>\n \n 28 – 32<\/td>\n 74 \u2192 60<\/td>\n 26 \u2192 40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Water (2.5.12)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Nicotine\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nicotine-2-300x163.jpg\")
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