{"id":10632,"date":"2025-10-08T11:14:47","date_gmt":"2025-10-08T04:14:47","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=10632"},"modified":"2025-10-08T11:14:47","modified_gmt":"2025-10-08T04:14:47","slug":"dihydrocodeine-tartrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/dihydrocodeine-tartrate\/","title":{"rendered":"Dihydrocodeine Tartrate"},"content":{"rendered":"

(Dihydrocodeine Hydrogen Tartrate, Ph. Eur. monograph 1776)<\/p>\n

C22<\/sub>H29<\/sub>NO9\u00a0<\/sub> \u00a0 \u00a0 \u00a0451.5\u00a0 \u00a0 \u00a0 \u00a0 \u00a05965-13-9<\/p>\n

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

Opioid receptor agonist; analgesic.<\/p>\n

Preparations<\/strong><\/p>\n

Co-dydramol Tablets<\/p>\n

Dihydrocodeine Injection<\/p>\n

Dihydrocodeine Oral Solution<\/p>\n

Dihydrocodeine Tablets<\/p>\n

Dihydrocodeine Prolonged-release Tablets<\/p>\n

DEFINITION<\/h2>\n

4,5\u03b1-Epoxy-3-methoxy-17-methylmorphinan-6\u03b1-ol hydrogen (2R,3R)-2,3-dihydroxybutanedioate.<\/p>\n

Content<\/h3>\n

98.5 per cent to 101.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in cyclohexane.<\/p>\n

IDENTIFICATION<\/h2>\n

First identification: A.<\/p>\n

Second identification: B, C, D.<\/p>\n

A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison: Ph. Eur. reference spectrum of dihydrocodeine hydrogen tartrate.<\/p>\n

B. To about 0.1 g add 1 mL of sulfuric acid R and 0.05 mL of ferric chloride solution R1 and heat on a water-bath. A brownish-yellow colour develops. Add 0.05 mL of dilute nitric acid R. The colour does not become red.<\/p>\n

C. To 1 mL of solution S (see Tests) add 5 mL of picric acid solution R. Heat on a water-bath until a clear solution is obtained. Allow to cool. A precipitate is formed. Filter, wash with 5 mL of water R and dry at 100-105 \u00b0C. The crystals melt (2.2.14) at 220 \u00b0C to 223 \u00b0C.<\/p>\n

D. It gives reaction (b) of tartrates (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 2.50 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

Solution S is clear (2.2.1) and not more intensely coloured than reference solution BY5<\/sub> (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h4>\n

3.2 to 4.2 for solution S.<\/p>\n

Specific optical rotation (2.2.7)<\/h4>\n

-70.5 to -73.5 (anhydrous substance).<\/p>\n

Dilute 10.0 mL of solution S to 20.0 mL with water R.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Test solution: Dissolve 10.0 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 2.0 mg of codeine phosphate R in 2.0 mL of the test solution and dilute to 25.0 mL with the mobile phase.<\/p>\n

Reference solution (b): Dilute 1.0 mL of the test solution to 200 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm,<\/p>\n

\u2014 stationary phase: octylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n

Mobile phase: To 1.0 g of sodium heptanesulfonate R, add 10.0 mL of glacial acetic acid R and 4.0 mL of a solution of 5.0 mL of triethylamine R diluted to 25.0 mL with a mixture of equal volumes of water R and acetonitrile R. Add 170 mL of acetonitrile R and dilute to 1000 mL with water R.<\/p>\n

Flow rate: 1 mL\/min.<\/p>\n

Detection: Spectrophotometer at 284 nm.<\/p>\n

Injection: 20 \u03bcL.<\/p>\n

Run time: 5 times the retention time of dihydrocodeine.<\/p>\n

Retention time: Dihydrocodeine = about 14 min.<\/p>\n

System suitability: Reference solution (a):<\/p>\n

\u2014 resolution: minimum of 2 between the peaks due to dihydrocodeine and to impurity A.<\/p>\n

Limits:<\/p>\n

\u2014 impurity A: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent),<\/p>\n

\u2014 any other peak: not more than 0.6 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent),<\/p>\n

\u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (1 per cent); disregard any peak due to tartaric acid (relative retention with reference to dihydrocodeine = about 0.25),<\/p>\n

\u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n

Water (2.5.12)<\/h4>\n

Maximum 0.7 per cent, determined on 1.00 g.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.350 g in 60 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 45.15 mg of C22<\/sub>H29<\/sub>NO9<\/sub>.<\/p>\n

STORAGE<\/h2>\n

Protected from light.<\/p>\n

IMPURITIES<\/h2>\n

\"Dihydrocodeine<\/p>\n

A. 7,8-didehydro-4,5\u03b1-epoxy-3-methoxy-17-methylmorphinan-6\u03b1-ol (codeine),<\/p>\n

\"Dihydrocodeine<\/p>\n

B. 7,8-didehydro-4,5\u03b1-epoxy-17-methylmorphinan-3,6\u03b1-diol (morphine),<\/p>\n

\"Dihydrocodeine<\/p>\n

C. 4,5\u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one (hydrocodone),<\/p>\n

\"Dihydrocodeine<\/p>\n

D. 4,5\u03b1-epoxy-3,6\u03b1-dimethoxy-17-methylmorphinan (tetrahydrothebaine).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Dihydrocodeine Hydrogen Tartrate, Ph. Eur. monograph 1776) C22H29NO9\u00a0 \u00a0 \u00a0 \u00a0451.5\u00a0 \u00a0 \u00a0 \u00a0 \u00a05965-13-9 Action and use Opioid receptor agonist; analgesic. Preparations Co-dydramol Tablets Dihydrocodeine Injection Dihydrocodeine Oral Solution Dihydrocodeine Tablets Dihydrocodeine Prolonged-release Tablets DEFINITION 4,5\u03b1-Epoxy-3-methoxy-17-methylmorphinan-6\u03b1-ol hydrogen (2R,3R)-2,3-dihydroxybutanedioate. Content 98.5 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white,…<\/p>\n","protected":false},"author":2,"featured_media":10646,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-10632","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\/10632","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=10632"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10632\/revisions"}],"predecessor-version":[{"id":10649,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10632\/revisions\/10649"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10646"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10632"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10632"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10632"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}