Action and use<\/strong><\/p>\n Local anaesthetic.<\/p>\n (2RS)-N-(2,6-Dimethylphenyl)-1-methylpiperidine-2-carboxamide hydrochloride.<\/p>\n Content<\/strong><\/p>\n 98.5 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white, crystalline powder.<\/p>\n Freely soluble in water and in ethanol (96 per cent), very slightly soluble in methylene chloride.<\/p>\n About 260 \u00b0C, with decomposition.<\/p>\n It shows polymorphism (5.9).<\/p>\n First identification: A, C.<\/p>\n Second identification: B, C.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison mepivacaine hydrochloride CRS.<\/p>\n If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in methanol R, evaporate to dryness and dry in an oven at 80 \u00b0C for 45 min. Record new spectra using the residues.<\/p>\n B. Thin-layer chromatography (2.2.27).<\/p>\n Test solution Dissolve 20 mg of the substance to be examined in ethanol (96 per cent) R and dilute to 5 mL with the same solvent.<\/p>\n Reference solution (a) Dissolve 20 mg of mepivacaine hydrochloride CRS in ethanol (96 per cent) R and dilute to 5 mL with the same solvent.<\/p>\n Reference solution (b) Dissolve 20 mg of mepivacaine hydrochloride CRS and 20 mg of lidocaine hydrochloride CRS in ethanol (96 per cent) R and dilute to 5 mL with the same solvent.<\/p>\n Plate TLC silica gel F254 plate R.<\/p>\n Mobile phase concentrated ammonia R, methanol R, 1,1-dimethylethyl methyl ether R (1:5:100 V\/V\/V).<\/p>\n Application 10 \u03bcL.<\/p>\n Development Over 2\/3 of the plate.<\/p>\n Drying In air.<\/p>\n Detection Examine in ultraviolet light at 254 nm.<\/p>\n System suitability Reference solution (b):<\/p>\n \u2014 the chromatogram shows 2 clearly separated principal spots.<\/p>\n Results The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a).<\/p>\n C. It gives reaction (a) of chlorides (2.3.1).<\/p>\n Dissolve 1.500 g in carbon dioxide-free water R and dilute to 30.0 mL with the same solvent.<\/p>\n Solution S is clear (2.2.1) and not more intensely coloured than reference solution B7<\/p>\n (2.2.2, Method II).<\/p>\n 4.0 to 5.0.<\/p>\n Dilute 2 mL of solution S to 5 mL with carbon dioxide-free water R.<\/p>\n -0.10\u00b0 to + 0.10\u00b0, determined on solution S.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution Dissolve 20.0 mg of the substance to be examined in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n Reference solution (a) Dissolve 20.0 mg of the substance to be examined and 30.0 mg of mepivacaine impurity B CRS in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 100.0 mL with the mobile phase.<\/p>\n Reference solution (b) Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.125 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n Mobile phase Mix 35 volumes of acetonitrile R1 and 65 volumes of a 2.25 g\/L solution of phosphoric acid R, previously adjusted to pH 7.6 with strong sodium hydroxide solution R.<\/p>\n Flow rate 1 mL\/min.<\/p>\n Detection Spectrophotometer at 220 nm.<\/p>\n Injection 20 \u03bcL.<\/p>\n Run time 3 times the retention time of mepivacaine.<\/p>\n Identification of impurities Use the chromatogram obtained with reference solution (a) to identify the peak due to impurity B.<\/p>\n Relative retention With reference to mepivacaine (retention time = about 7 min): impurity B = about 0.5.<\/p>\n System suitability Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.5 between the peaks due to impurity B and mepivacaine.<\/p>\n Limits:<\/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 5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 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 Impurity A<\/p>\n Head-space gas chromatography (2.2.28).<\/p>\n Test solution Introduce 60.0 mg of the substance to be examined into a 20 mL vial. Add 2.0 mL of a 103.0 g\/L solution of hydrochloric acid R and 1.0 mL of a 126.0 g\/L solution of sodium hydroxide R, and close the vial immediately.<\/p>\n Reference solution Dissolve 6.0 mg of bupivacaine impurity F CRS (impurity A) in a 103.0 g\/L solution of hydrochloric acid R and dilute to 100.0 mL with the same acid solution. Dilute 1.0 mL of this solution to 100.0 mL with a 103.0 g\/L solution of hydrochloric acid R. Introduce 2.0 mL of this solution into a 20 mL vial, add 1.0 mL of a 126.0 g\/L solution of sodium hydroxide R, and close the vial immediately.<\/p>\n Column:<\/p>\n \u2014 material: fused silica;<\/p>\n \u2014 size: l = 30 m, \u00d8 = 0.53 mm;<\/p>\n \u2014 stationary phase: cyanopropyl(3)phenyl(3)methyl(94)polysiloxane R (film thickness 3 \u03bcm).<\/p>\n Carrier gas helium for chromatography R.<\/p>\n Flow rate 4.0 mL\/min.<\/p>\n Split ratio 1:1.<\/p>\n Static head-space conditions that may be used:<\/p>\n \u2014 equilibration temperature: 90 \u00b0C;<\/p>\n \u2014 equilibration time: 25 min;<\/p>\n \u2014 pressurisation time: 2 min.<\/p>\n Temperature:<\/p>\n (min)<\/strong><\/td>\n (\u00b0C)<\/strong><\/td>\n<\/tr>\n <\/p>\n Injection port<\/p>\n Detector<\/td>\n 10 – 15<\/td>\n 230<\/p>\n 225<\/p>\n 250<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Detection Flame ionisation.<\/p>\n Retention time Impurity A = about 6 min.<\/p>\n System suitability Reference solution:<\/p>\n \u2014 repeatability: maximum relative standard deviation of 15.0 per cent determined on 6 injections.<\/p>\n Calculation of content:<\/p>\n \u2014 for impurity A, use the concentration of impurity A in the reference solution.<\/p>\n Limit:<\/p>\n \u2014 impurity A: maximum 20 ppm.<\/p>\n Loss on drying (2.2.32)<\/p>\n Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Sulfated ash (2.4.14)<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.250 g in a mixture of 5.0 mL of 0.01 M hydrochloric acid and 50 mL of ethanol (96 per cent) R. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 28.28 mg of C15<\/sub>H23<\/sub>ClN2<\/sub>O.<\/p>\n Specified impurities A.<\/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) B, C, D, E.<\/p>\n A. 2,6-dimethylaniline,<\/p>\n B. (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide,<\/p>\n C. N-(2,6-dimethylphenyl)pyridine-2-carboxamide,<\/p>\n D. (2RS)-N-(2,6-dimethylphenyl)-1-methyl-1,2,5,6-tetrahydropyridine-2-carboxamide,<\/p>\n E. (2RS)-N-(4-chloro-2,6-dimethylphenyl)-1-methylpiperidine-2-carboxamide.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) C15H23ClN2O 282.8 1722-62-9 Action and use Local anaesthetic. DEFINITION (2RS)-N-(2,6-Dimethylphenyl)-1-methylpiperidine-2-carboxamide hydrochloride. Content 98.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water and in ethanol (96 per cent), very slightly soluble in methylene chloride. mp About…<\/p>\n","protected":false},"author":5,"featured_media":24075,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-23999","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\/23999","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=23999"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23999\/revisions"}],"predecessor-version":[{"id":24100,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/23999\/revisions\/24100"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24075"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=23999"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=23999"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=23999"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
mp<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
pH (2.2.3)<\/h3>\n
Optical rotation (2.2.7)<\/h3>\n
Related substances<\/h3>\n
\n\n
\n <\/td>\n Time<\/strong><\/p>\n Temperature<\/strong><\/p>\n \n Column<\/p>\n 0 – 10<\/p>\n 130 \u2192 230<\/p>\n ASSAY<\/h2>\n
IMPURITIES<\/h2>\n
![\"Mepivacaine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Mepivacaine-Hydrochloride-1.jpg\")
<\/p>\n![\"Mepivacaine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Mepivacaine-Hydrochloride-2.jpg\")
<\/p>\n![\"Mepivacaine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Mepivacaine-Hydrochloride-3.jpg\")
<\/p>\n![\"Mepivacaine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Mepivacaine-Hydrochloride-4.jpg\")
<\/p>\n![\"Mepivacaine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Mepivacaine-Hydrochloride-5.jpg\")
<\/p>\n