Action and use<\/strong><\/p>\n Cannabinoid receptor agonist; adjunctive therapy used in the treatment of seizures (epilepsy).<\/p>\n (1\u2032R,2\u2032R)-5\u2032-Methyl-4-pentyl-2\u2032-(prop-1-en-2-yl)-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-2,6-diol.<\/p>\n 98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n It is isolated from the Cannabis sativa L. plant.<\/p>\n White to pale yellow powder.<\/p>\n Practically insoluble in water, freely soluble in ethanol (96 per cent) and in methanol, soluble in heptane.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: cannabidiol CRS.<\/p>\n B. Specific optical rotation (see Tests).<\/p>\n -135.0 to -128.0 (anhydrous substance).<\/p>\n Dissolve 0.200 g in ethanol (96 per cent) R and dilute to 20.0 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution (a): Dissolve 15.0 mg of the substance to be examined in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n Test solution (b): Dilute 2.0 mL of test solution (a) to 10.0 mL with methanol R.<\/p>\n Reference solution (a): Dilute 1.0 mL of test solution (a) to 10.0 mL with methanol R. Dilute 1.0 mL of the solution to 100.0 mL with methanol R.<\/p>\n Reference solution (b): Dissolve 7.5 mg of cannabidiol for system suitability CRS (containing impurities A, B, C and E) in methanol R and dilute to 5 mL with the same solvent.<\/p>\n Reference solution (c): Dissolve 15.0 mg of cannabidiol CRS in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n Reference solution (d): Transfer 1 mL of reference solution (c) to a vial and add 25 \u03bcL of a 103 g\/L solution of hydrochloric acid R. Keep at room temperature for 2 h before injection to allow the in situ formation of impurity D.<\/p>\n Reference solution (e): Dissolve the contents of a vial of cannabidiol impurity J CRS in 1 mL of methanol R.<\/p>\n Reference solution (f): Dilute 2.0 mL of reference solution (c) to 10.0 mL with methanol R.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped, charged surface, ethylene-bridged phenylhexylsilyl silica gel for chromatography (hybrid material) R (2.5 \u03bcm);<\/p>\n \u2014 temperature: 45 \u00b0C.<\/p>\n Mobile phase:<\/p>\n \u2014 mobile phase A: a 1 g\/L solution of formic acid R;<\/p>\n \u2014 mobile phase B: acetonitrile R;<\/p>\n (min)<\/strong><\/td>\n (per cent V\/V)<\/strong><\/td>\n (per cent V\/V)<\/strong><\/td>\n<\/tr>\n Flow rate: 1.2 mL\/min.<\/p>\n Detection: Spectrophotometer at 275 nm.<\/p>\n Autosampler: Set at 5 \u00b0C.<\/p>\n Injection: 10 \u03bcL of test solution (a) and reference solutions (a), (b), (d) and (e).<\/p>\n Identification of impurities: Use the chromatogram supplied with cannabidiol for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B, C and E; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity D; use the chromatogram obtained with reference solution (e) to identify the peak due to impurity J.<\/p>\n Relative retention: With reference to cannabidiol (retention time = about 12 min): impurity J = about 0.49; impurity A = about 0.72; impurity B = about 0.85; impurity C = about 1.15; impurity D = about 1.21; impurity E = about 1.26.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to cannabidiol and impurity C.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factors: multiply the peak area of the impurity by its correction factor: impurity C = 0.05; impurity E = 0.08;<\/p>\n \u2014 for each impurity, use the concentration of the substance to be examined in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 impurity A: maximum 0.80 per cent;<\/p>\n \u2014 impurity B: maximum 0.50 per cent;<\/p>\n \u2014 impurities C, E and J: for each impurity, maximum 0.15 per cent;<\/p>\n \u2014 impurity D: maximum 0.10 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 1.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Maximum 0.5 per cent.<\/p>\n Dissolve 50.0 mg in anhydrous methanol R and dilute to 2.0 mL with the same solvent. Inject 0.8 mL of the solution through the septum.<\/p>\n Maximum 0.1 per cent determined on 1.0 g.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n Injection: Test solution (b) and reference solution (f).<\/p>\n Calculate the percentage content of C21<\/sub>H30<\/sub>O2<\/sub> taking into account the assigned content of cannabidiol CRS.<\/p>\n In an airtight container, protected from light.<\/p>\n The label states the origin of the substance:<\/p>\n \u2014 isolated from the Cannabis sativa L. plant.<\/p>\n Specified impurities A, B, C, D, E, J.<\/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) F, G, H, I, K.<\/p>\n A. (1\u2032R,2\u2032R)-5\u2032-methyl-2\u2032-(prop-1-en-2-yl)-4-propyl-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-2,6-diol (cannabidivarin),<\/p>\n B. (1\u2032R,2\u2032R)-4-butyl-5\u2032-methyl-2\u2032-(prop-1-en-2-yl)-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-2,6-diol (cannabidibutol),<\/p>\n C. 6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol (cannabinol),<\/p>\n D. (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-dibenzo[b,d]pyran-1-ol (\u0394 -tetrahydrocannabinol, dronabinol),<\/p>\n E. (1\u2032R,6\u2032R)-6-hydroxy-3\u2032-methyl-4-pentyl-6\u2032-(prop-1-en-2-yl)[[1,1\u2032-bi(cyclohexane)]-2\u2032,3,6-triene]-2,5-dione,<\/p>\n F. (2RS)-2-methyl-2-(4-methylpent-3-en-1-yl)-7-pentyl-2H-1-benzopyran-5-ol (cannabichromene),<\/p>\n G. (1\u2032R,2\u2032R)-2,6-dihydroxy-5\u2032-methyl-4-pentyl-2\u2032-(prop-1-en-2-yl)-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-3-carboxylic acid (cannabidiolic acid),<\/p>\n H. (6aR,10aR)-1-hydroxy-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-dibenzo[b,d]pyran-2-carboxylic acid (\u0394 -tetrahydrocannabinolic acid),<\/p>\n I. (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,10,10a-tetrahydro-6H-dibenzo[b,d]pyran-1-ol (\u0394 -tetrahydrocannabinol),<\/p>\n J. (1\u2032R,2\u2032R)-4,5\u2032-dimethyl-2\u2032-(prop-1-en-2-yl)-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-2,6-diol (cannabidiorcol),<\/p>\n K. 2-[(2E)-3,7-dimethylocta-2,6-dien-1-yl]-5-pentylbenzene-1,3-diol (cannabigerol).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 3151) C21H30O2\u00a0 \u00a0314.5\u00a0 \u00a013956-29-1 Action and use Cannabinoid receptor agonist; adjunctive therapy used in the treatment of seizures (epilepsy). DEFINITION (1\u2032R,2\u2032R)-5\u2032-Methyl-4-pentyl-2\u2032-(prop-1-en-2-yl)-1\u2032,2\u2032,3\u2032,4\u2032-tetrahydro[1,1\u2032-biphenyl]-2,6-diol. Content 98.0 per cent to 102.0 per cent (anhydrous substance). It is isolated from the Cannabis sativa L. plant. CHARACTERS Appearance White to pale yellow powder. Solubility Practically insoluble in water,…<\/p>\n","protected":false},"author":4,"featured_media":6244,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-6208","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\/6208","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=6208"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6208\/revisions"}],"predecessor-version":[{"id":8840,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6208\/revisions\/8840"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/6244"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=6208"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=6208"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=6208"}],"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
Specific optical rotation (2.2.7)<\/h3>\n
Related substances<\/h3>\n
\n\n
\n Time<\/strong><\/p>\n Mobile phase A<\/strong><\/p>\n Mobile phase B<\/strong><\/p>\n \n 0 – 6<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n \n 6 – 21<\/td>\n 100 \u2192 50<\/td>\n 0 \u2192 50<\/td>\n<\/tr>\n \n 21 – 30<\/td>\n 50<\/td>\n 50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Water (2.5.32)<\/h3>\n
Sulfated ash (2.4.14)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h3>\n
LABELLING<\/h3>\n
IMPURITIES<\/h3>\n
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