Oxymorphone Hydrochloride
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C17H19NO4·HCl 337.80

Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, hydrochloride, (5)-.
4,5-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride [357-07-3].
» Oxymorphone Hydrochloride contains not less than 97.0 percent and not more than 102.0 percent of C17H19NO4·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
A: Dissolve about 250 mg in 25 mL of water, and render the solution alkaline with a saturated solution of sodium bicarbonate. Extract the liberated oxymorphone with two 15-mL portions of chloroform. Reserve the chloroform extracts, combined in a second separator, for Identification test B: the aqueous phase, acidified with 2 N nitric acid, responds to the tests for Chloride 191.
B: Wash the combined chloroform extracts from Identification test A with 5 mL of water, and filter. Evaporate the chloroform solution on a steam bath nearly to dryness, then add a few mL of ether, and continue the evaporation with stirring until the solvent is removed: the IR absorption spectrum of a 1 in 50 solution in alcohol-free chloroform of the oxymorphone so obtained, determined in a 0.5-mm cell, exhibits maxima only at the same wavelengths as that of a similar solution of USP Oxymorphone RS.
C: The UV absorption spectrum of a 1 in 6500 solution in 0.1 N hydrochloric acid exhibits maxima and minima at the same wavelengths as that of a solution of USP Oxymorphone RS, prepared by dissolving about 20 mg of the Reference Standard in 10 mL of 1 N hydrochloric acid and diluting with water to 100.0 mL. The ratio A281 / A264 is 1.75 ± 0.2.
D: Dissolve 10 mg in 1 mL of water, and add a few drops of ferric chloride TS: a blue color is produced immediately.
Specific rotation 781S: between 145 and 155.
Test solution: 100 mg per mL, in water.
Acidity— Dissolve 300 mg in 10 mL of water, add 1 drop of methyl red TS, and titrate with 0.020 N sodium hydroxide: not more than 0.30 mL is required to produce a yellow color.
Loss on drying 731 Dry it at 105 for 18 hours: it loses not more than 8.0% of its weight.
Residue on ignition 281: not more than 0.3%.
Limit of nonphenolic substances— Dissolve 1 g in 15 mL of water, add 5 mL of sodium hydroxide solution (2 in 25), and extract with three 10-mL portions of chloroform. Filter the combined extracts through a small chloroform-moistened filter paper, and wash the filtrate with 5 mL of water. Filter the chloroform layer through chloroform-moistened filter paper into a tared, 50-mL beaker, and evaporate on a steam bath with the aid of a gentle current of filtered air to dryness. Dry the beaker and residue at 105 for 1 hour, and weigh: the residue so obtained does not exceed 15 mg.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of dehydrated alcohol, cyclohexane, and ammonium hydroxide (10:5:1).
Visualization: 1.
Chloride content— Dissolve about 300 mg, accurately weighed, in 50 mL of methanol in a glass-stoppered flask, add 5 mL of glacial acetic acid and 3 drops of eosin Y TS, and titrate with 0.1 N silver nitrate VS. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of Cl: the content is between 10.2% and 10.8%, calculated on the dried basis.
Assay— Transfer about 700 mg of Oxymorphone Hydrochloride, accurately weighed, to a glass-stoppered flask containing 50 mL of glacial acetic acid and 10 mL of mercuric acetate TS. Add 3 mL of acetic anhydride and 1 drop of methyl violet TS, and titrate with 0.1 N perchloric acid VS to a clear blue color. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 33.78 mg of C17H19NO4·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3176
Pharmacopeial Forum: Volume No. 29(6) Page 1946