{"id":26092,"date":"2025-11-05T11:07:31","date_gmt":"2025-11-05T04:07:31","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26092"},"modified":"2025-11-05T11:07:31","modified_gmt":"2025-11-05T04:07:31","slug":"oxycodone-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxycodone-hydrochloride\/","title":{"rendered":"Oxycodone Hydrochloride"},"content":{"rendered":"

(Ph. Eur. monograph 1793)<\/p>\n

C18<\/sub>H22<\/sub>ClNO4<\/sub>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 351.9\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0124-90-3<\/p>\n

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

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

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

Oxycodone Capsules<\/p>\n

Oxycodone Injection<\/p>\n

Oxycodone Oral Solution<\/p>\n

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

DEFINITION<\/h2>\n

4,5\u03b1-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.<\/p>\n

Content<\/h3>\n

98.5 per cent to 101.5 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Freely soluble in water, sparingly soluble in anhydrous ethanol, practically insoluble in toluene.<\/p>\n

IDENTIFICATION<\/h2>\n

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

Preparation: Discs.<\/p>\n

Dissolve 50 mg in water R and dilute to 5 mL with the same solvent. Render the solution alkaline with dilute ammonia R1. Allow the mixture to stand until a precipitate is formed. Filter, wash the precipitate with 10 mL of cold water R, and dry for 1 h at 105 \u00b0C. Examine the precipitate.<\/p>\n

Comparison: Repeat the operations using 50 mg of oxycodone hydrochloride CRS.<\/p>\n

B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 1.00 g in carbon dioxide-free water R and dilute to 50.0 mL with the same solvent.<\/p>\n

Acidity or alkalinity<\/h3>\n

To 10 mL of solution S add 0.05 mL of methyl red solution R. Not more than 0.2 mL of 0.02 M sodium hydroxide or 0.02 M hydrochloric acid is required to change the colour of the indicator.<\/p>\n

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

-140 to -148 (anhydrous substance), determined on solution S.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29). Prepare the solutions protected from light.<\/p>\n

Test solution: Dissolve 0.100 g of the substance to be examined in a 1 per cent V\/V solution of dilute acetic acid R and dilute to 50.0 mL with the same solvent.<\/p>\n

Reference solution (a): Dissolve 20.0 mg of oxycodone impurity D CRS in a 1 per cent V\/V solution of dilute acetic acid R and dilute to 10.0 mL with the same solution.<\/p>\n

Reference solution (b): To 1.0 mL of the test solution, add 1.0 mL of reference solution (a) and dilute to 100.0 mL with a 1 per cent V\/V solution of dilute acetic acid R. Dilute 1.0 mL of the solution to 10.0 mL with a 1 per cent V\/V solution of dilute acetic acid R.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n

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

\u2014 temperature: 40 \u00b0C.<\/p>\n

Mobile phase:<\/p>\n

\u2014 mobile phase A: mix 830 mL of a 1.1 g\/L solution of sodium heptanesulfonate monohydrate R previously adjusted to pH 2.0 with a mixture of equal volumes of phosphoric acid R and water R, with 70 mL of acetonitrile R and 100 mL of methanol R;<\/p>\n

\u2014 mobile phase B: mix 600 mL of a 1.1 g\/L solution of sodium heptanesulfonate monohydrate R previously adjusted to pH 2.0 with a mixture of equal volumes of phosphoric acid R and water R, with 150 mL of acetonitrile R and 250 mL of methanol R;<\/p>\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 – 60<\/td>\n100 \u2192 50<\/td>\n0 \u2192 50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Flow rate: 1.5 mL\/min.<\/p>\n

Detection: Spectrophotometer at 230 nm.<\/p>\n

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

Relative retention: With reference to oxycodone (retention time = about 24 min): impurity A = about 0.4; impurity B = about 0.7; impurity C = about 1.14; impurity D = about 1.18; impurity E = about 1.18; impurity F = about 2.4.<\/p>\n

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

\u2014 resolution: minimum 3 between the peaks due to oxycodone and impurity D.<\/p>\n

Limits:<\/p>\n

\u2014 correction factor: for the calculation of content, multiply the peak area of impurity F by 0.5;<\/p>\n

\u2014 sum of impurities D and E: not more than 10 times the area of the peak due to oxycodone in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n

\u2014 impurities A, B, C, F: for each impurity, not more than the area of the peak due to oxycodone in the chromatogram obtained with reference solution (b) (0.1 per cent);<\/p>\n

\u2014 any other impurity: for each impurity, not more than the area of the peak due to oxycodone in the chromatogram obtained with reference solution (b) (0.1 per cent);<\/p>\n

\u2014 total: not more than 15 times the area of the peak due to oxycodone in the chromatogram obtained with reference solution (b) (1.5 per cent);<\/p>\n

\u2014 disregard limit: 0.5 times the area of the peak due to oxycodone in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n

Ethanol (2.4.24, System A)<\/h3>\n

Maximum 1.0 per cent.<\/p>\n

Water (2.5.12)<\/h4>\n

Maximum 7.0 per cent, determined on 0.250 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 0.250 g in a mixture of 5.0 mL of 0.01 M hydrochloric acid and 60 mL of ethanol (96 per cent) R. Titrate with 0.1 M ethanolic sodium hydroxide, determining the end-point potentiometrically (2.2.20). Measure the volume used between the 2 inflexion points.<\/p>\n

1 mL of 0.1 M ethanolic sodium hydroxide is equivalent to 35.19 mg of C18<\/sub>H22<\/sub>ClNO4<\/sub>.<\/p>\n

STORAGE<\/h2>\n

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

IMPURITIES<\/h2>\n

Specified impurities A, B, C, D, E, F.<\/p>\n

\"Oxycodone<\/p>\n

A. 4,5\u03b1-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one (oxymorphone),<\/p>\n

\"Oxycodone<\/p>\n

B. 4,5\u03b1-epoxy-3-methoxy-17-methylmorphinan-6\u03b1,14-diol (7,8-dihydro-14-hydroxycodeine),<\/p>\n

\"Oxycodone<\/p>\n

C. 4,5\u03b1-epoxy-14-hydroxy-3-methoxymorphinan-6-one (noroxycodone),<\/p>\n

\"Oxycodone<\/p>\n

D. 7,8-didehydro-4,5\u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one (14-hydroxycodeinone),<\/p>\n

\"Oxycodone<\/p>\n

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

\"Oxycodone<\/p>\n

F. 6,7,8,14-tetradehydro-4,5\u03b1-epoxy-3-6-dimethoxy-17-methylmorphinan (thebain).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 1793) C18H22ClNO4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 351.9\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0124-90-3 Action and use Opioid receptor agonist; analgesic. Preparations Oxycodone Capsules Oxycodone Injection Oxycodone Oral Solution Oxycodone Prolonged-release Tablets DEFINITION 4,5\u03b1-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Content 98.5 per cent to 101.5 per cent (anhydrous substance). CHARACTERS Appearance White or almost white powder, hygroscopic. Solubility…<\/p>\n","protected":false},"author":2,"featured_media":26114,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26092","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\/26092","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=26092"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26092\/revisions"}],"predecessor-version":[{"id":26121,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26092\/revisions\/26121"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26114"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}