{"id":25282,"date":"2025-11-04T10:54:31","date_gmt":"2025-11-04T03:54:31","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=25282"},"modified":"2025-11-04T10:54:31","modified_gmt":"2025-11-04T03:54:31","slug":"nicotine-resinate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nicotine-resinate\/","title":{"rendered":"Nicotine Resinate"},"content":{"rendered":"

(Ph. Eur. monograph 1792)<\/p>\n

96055-45-7<\/p>\n

Action and use<\/strong><\/p>\n

Aid to smoking cessation.<\/p>\n

Preparation<\/strong><\/p>\n

Nicotine Resinate Medicated Chewing Gum<\/p>\n

DEFINITION<\/h2>\n
Complex of nicotine (3-[(2S)-1-methylpyrrolidin-2-yl]pyridine) with a weak cationic exchange resin.<\/p>\n
Content<\/h3>\n
95.0 per cent to 115.0 per cent of the declared content of nicotine (C_{10<\/sub>H_{14<\/sub>N_{2<\/sub>) stated on the label (dried substance).<\/p>\n}}}
It may contain glycerol.<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or slightly yellowish powder, hygroscopic.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Preparation: Shake a quantity of the substance to be examined equivalent to 100 mg of nicotine with a mixture of 10 mL of dilute ammonia R2, 10 mL of water R, 5 mL of strong sodium hydroxide solution R and 20 mL of hexane R for 5 min. Transfer the upper layer to a beaker and evaporate to produce an oily residue.
\nRecord the spectrum of the oily residue as a thin film between sodium chloride R plates.<\/p>\n
Comparison: Ph. Eur. reference spectrum of nicotine.<\/p>\n
B. Nicotine release (see Tests).<\/p>\n
TESTS<\/h2>\n
Nicotine release<\/h3>\n
Minimum 70 per cent of the content determined under Assay in 10 min.<\/p>\n
Transfer an accurately weighed quantity of the substance to be examined, equivalent to about 4 mg of nicotine, to a glass-stoppered test-tube, add 10.0 mL of a 9 g\/L solution of sodium chloride R previously heated to 37 \u00b0C and shake vigorously for 10 min. Immediately filter the liquid through a dry filter paper discarding the 1^{st<\/sup> millilitre of filtrate. Transfer 1.0 mL of the filtrate to a 20 mL volumetric flask, dilute to 20 mL with 0.1 M hydrochloric acid and mix. Determine the absorbance (2.2.25) at the minima at about 236 nm and 282 nm and at the maximum at 259 nm using 1.0 mL of a 9 g\/L solution of sodium chloride R diluted to
\n20 mL with 0.1 M hydrochloric acid as compensation liquid.<\/p>\n}
Calculate the percentage of nicotine release using the following expression:<\/p>\n
$\"Nicotine$ <\/p>\n
323 = specific absorbance of nicotine at 259 nm;<\/p>\n
C = percentage of nicotine in the substance to be examined determined in the assay;<\/p>\n
m = mass of the substance to be examined, in milligrams;<\/p>\n
A_{236<\/sub>, A_{259<\/sub>, A_{282<\/sub> = absorbances of the solution at the wavelength indicated by the subscript.<\/p>\n}}}
Related substances<\/h3>\n
Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n
Test solution Weigh a quantity of the substance to be examined, equivalent to 30.0 mg of nicotine, into a glass-stoppered test-tube, add 10.0 mL of dilute ammonia R2 and shake vigorously for 10 min. Centrifuge for 20 min at about 3000 r\/min. To 5.0 mL of the clear solution, add 5 mL of a 60 g\/L solution of acetic acid R and dilute to 25.0 mL with water R.<\/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.<\/p>\n
Reference solution (b): Dilute 1.0 mL of the test solution to 10.0 mL with water R. Dilute 1.0 mL of this solution to 100.0 mL with water R.<\/p>\n
Reference solution (c): Dissolve 46.0 mg of nicotine ditartrate CRS in water R and dilute to 25.0 mL with the same solvent.<\/p>\n
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, then add 6 mL of concentrated ammonia R1; adjust to pH 10.0 with dilute ammonia R2 or dilute acetic acid R and dilute to 1 L with water R;<\/p>\n
\u2014 mobile phase B: acetonitrile R;<\/p>\n\n\n\n\n\n\n\n
Time<\/strong>
\n(min)<\/strong><\/td>\n Mobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n Mobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 3<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n
3 – 3.01<\/td>\n 100 \u2192 95<\/td>\n 0 \u2192 5<\/td>\n<\/tr>\n
3.01 – 28<\/td>\n 95 \u2192 74<\/td>\n 5 \u2192 26<\/td>\n<\/tr>\n
28 – 32<\/td>\n 74 \u2192 60<\/td>\n 26 \u2192 40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.0 mL\/min.<\/span><\/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 18 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
Loss on drying (2.2.32)<\/h4>\n
Maximum 7.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n
ASSAY<\/h2>\n
Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n
Injection: Test solution and reference solution (c).<\/p>\n
Calculate the percentage content of nicotine (C_{10<\/sub>H_{14<\/sub>N_{2<\/sub>) taking into account the assigned content of C_{10<\/sub>H_{14<\/sub>N_{2<\/sub> in nicotine ditartrate CRS.<\/p>\n}}}}}}
STORAGE<\/h2>\n
In an airtight container, protected from light.<\/p>\n
LABELLING<\/h2>\n
The label states the content of nicotine.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, B, C, D, E, F, G.<\/p>\n
$\"Nicotine$ <\/p>\n
A. (2S)-1,2,3,6-tetrahydro-2,3\u2032-bipyridine (anatabine),<\/p>\n
$\"Nicotine$ <\/p>\n
B. 3-(1-methyl-1H-pyrrol-2-yl)pyridine (\u03b2-nicotyrine),<\/p>\n
$\"Nicotine$ <\/p>\n
C. (5S)-1-methyl-5-(pyridin-3-yl)pyrrolidin-2-one (cotinine),<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 1792) 96055-45-7 Action and use Aid to smoking cessation. Preparation Nicotine Resinate Medicated Chewing Gum DEFINITION Complex of nicotine (3-[(2S)-1-methylpyrrolidin-2-yl]pyridine) with a weak cationic exchange resin. Content 95.0 per cent to 115.0 per cent of the declared content of nicotine (C10H14N2) stated on the label (dried substance). It may contain glycerol. CHARACTERS…<\/p>\n","protected":false},"author":2,"featured_media":25290,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25282","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\/25282","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=25282"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25282\/revisions"}],"predecessor-version":[{"id":25292,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25282\/revisions\/25292"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25290"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25282"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25282"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong> \n(min)<\/strong><\/td>\n	Mobile phase A<\/strong> \n(per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong> \n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 3<\/td>\n	100<\/td>\n	0<\/td>\n<\/tr>\n
3 – 3.01<\/td>\n	100 \u2192 95<\/td>\n	0 \u2192 5<\/td>\n<\/tr>\n
3.01 – 28<\/td>\n	95 \u2192 74<\/td>\n	5 \u2192 26<\/td>\n<\/tr>\n
28 – 32<\/td>\n	74 \u2192 60<\/td>\n	26 \u2192 40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.0 mL\/min.<\/span><\/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 18 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 Loss on drying (2.2.32)<\/h4>\n Maximum 7.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n ASSAY<\/h2>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n Injection: Test solution and reference solution (c).<\/p>\n Calculate the percentage content of nicotine (C_{10<\/sub>H_{14<\/sub>N_{2<\/sub>) taking into account the assigned content of C_{10<\/sub>H_{14<\/sub>N_{2<\/sub> in nicotine ditartrate CRS.<\/p>\n}}}}}} STORAGE<\/h2>\n In an airtight container, protected from light.<\/p>\n LABELLING<\/h2>\n The label states the content of nicotine.<\/p>\n IMPURITIES<\/h2>\n Specified impurities A, B, C, D, E, F, G.<\/p>\n $\"Nicotine$ <\/p>\n A. (2S)-1,2,3,6-tetrahydro-2,3\u2032-bipyridine (anatabine),<\/p>\n $\"Nicotine$ <\/p>\n B. 3-(1-methyl-1H-pyrrol-2-yl)pyridine (\u03b2-nicotyrine),<\/p>\n $\"Nicotine$ <\/p>\n C. (5S)-1-methyl-5-(pyridin-3-yl)pyrrolidin-2-one (cotinine),<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1792) 96055-45-7 Action and use Aid to smoking cessation. Preparation Nicotine Resinate Medicated Chewing Gum DEFINITION Complex of nicotine (3-[(2S)-1-methylpyrrolidin-2-yl]pyridine) with a weak cationic exchange resin. Content 95.0 per cent to 115.0 per cent of the declared content of nicotine (C10H14N2) stated on the label (dried substance). It may contain glycerol. CHARACTERS…<\/p>\n","protected":false},"author":2,"featured_media":25290,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25282","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\/25282","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=25282"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25282\/revisions"}],"predecessor-version":[{"id":25292,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25282\/revisions\/25292"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25290"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25282"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25282"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n95.0 per cent to 115.0 per cent of the declared content of nicotine (C10<\/sub>H14<\/sub>N2<\/sub>) stated on the label (dried substance).<\/p>\nIt may contain glycerol.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nWhite or slightly yellowish powder, hygroscopic.<\/p>\n

Solubility<\/h3>\nPractically insoluble in water.<\/p>\n

TESTS<\/h2>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 7.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

STORAGE<\/h2>\nIn an airtight container, protected from light.<\/p>\n

LABELLING<\/h2>\nThe label states the content of nicotine.<\/p>\n

Content<\/h3>\n
95.0 per cent to 115.0 per cent of the declared content of nicotine (C_{10<\/sub>H_{14<\/sub>N_{2<\/sub>) stated on the label (dried substance).<\/p>\n}}}
It may contain glycerol.<\/p>\n

Appearance<\/h3>\n
White or slightly yellowish powder, hygroscopic.<\/p>\n

Solubility<\/h3>\n
Practically insoluble in water.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n
Maximum 7.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

STORAGE<\/h2>\n
In an airtight container, protected from light.<\/p>\n

LABELLING<\/h2>\n
The label states the content of nicotine.<\/p>\n