Action and use<\/strong><\/p>\n Opioid receptor agonist; analgesic.<\/p>\n 4,5\u03b1-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride.<\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white, crystalline powder.<\/p>\n Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: hydromorphone hydrochloride CRS.<\/p>\n B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n Dissolve 1.250 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\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 To 2 mL of solution S add 0.1 mL of methyl red solution R. The solution is not yellow. To 2 mL of solution S add 0.05 mL of bromocresol green solution R. The solution is not yellow.<\/p>\n -136 to -140 (dried substance), determined on solution S.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution: Dissolve 0.100 g of the substance to be examined in water R, sonicating if necessary and dilute to 100.0 mL with the same solvent.<\/p>\n Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with water R. Dilute 1.0 mL of this solution to 10.0 mL with water R.<\/p>\n Reference solution (b): To 5 mL of the test solution add 5 mg of naloxone hydrochloride dihydrate CRS and dilute to 50 mL with water R.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 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: Dissolve 18.29 g of diethylamine R and 2.88 g of sodium laurilsulfate R in water R and dilute to 1000 mL with the same solvent. Adjust 800 mL of this solution to pH 3.0 with phosphoric acid R. Add 100 mL of acetonitrile R and 100 mL of methanol R.<\/p>\n Flow rate: 1 mL\/min.<\/p>\n Detection: Spectrophotometer at 284 nm.<\/p>\n Injection: 20 \u03bcL.<\/p>\n Run time: 4 times the retention time of hydromorphone.<\/p>\n Relative retention: With reference to hydromorphone (retention time = about 9 min): impurity D = about 0.72; impurity B = about 0.77; impurity C = about 0.82; impurity A = about 3.2.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 4.0 between the peaks due to hydromorphone and naloxone.<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3 per cent);<\/p>\n \u2014 impurities B, C, D: for each impurity, not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 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 (a) (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 (a) (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 (a) (0.05 per cent).<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Maximum 0.1 per cent, determined on the residue obtained in the test for loss on drying.<\/p>\n Dissolve 0.250 g in 50 mL of ethanol (96 per cent) R and add 5.0 mL of 0.01 M hydrochloric acid. 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 32.18 mg of C17<\/sub>H20<\/sub>ClNO3<\/sub>.<\/p>\n Protected from light.<\/p>\n Specified impurities A, B, C, D.<\/p>\n A. 4,5\u03b1:4\u2032,5\u2032\u03b1-diepoxy-3,3\u2032-dihydroxy-17,17\u2032-dimethyl-2,2\u2032-bimorphinanyl-6,6\u2032-dione (pseudohydromorphone),<\/p>\n B. 4,5\u03b1-epoxy-3-hydroxy-17-methylmorphinan-6-one 17-oxide (hydromorphone N-oxide),<\/p>\n C. 7,8-didehydro-4,5\u03b1-epoxy-17-methylmorphinan-3,6\u03b1-diol (morphine),<\/p>\n D. 4,5\u03b1-epoxy-17-methylmorphinan-3,6\u03b1-diol (dihydromorphine).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 2099) C17H20ClNO3\u00a0 \u00a0 \u00a0 \u00a0321.8\u00a0 \u00a0 \u00a0 \u00a071-68-1 Action and use Opioid receptor agonist; analgesic. DEFINITION 4,5\u03b1-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in…<\/p>\n","protected":false},"author":2,"featured_media":15046,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-15021","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\/15021","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=15021"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15021\/revisions"}],"predecessor-version":[{"id":15050,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15021\/revisions\/15050"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/15046"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=15021"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=15021"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=15021"}],"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
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Acidity or alkalinity<\/h3>\n
Specific optical rotation (2.2.7)<\/h4>\n
Related substances<\/h3>\n
Loss on drying (2.2.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Hydromorphone](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Hydromorphone-Hydrochloride-A-300x163.jpg\")
<\/p>\n![\"Hydromorphone](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Hydromorphone-Hydrochloride-B-300x163.jpg\")
<\/p>\n![\"Hydromorphone](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Hydromorphone-Hydrochloride-C-300x163.jpg\")
<\/p>\n![\"Hydromorphone](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Hydromorphone-Hydrochloride-D-300x163.jpg\")
<\/p>\n