Hydromorphone Hydrochloride
Click to View Image
C17H19NO3·HCl 321.80

Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5)-.
4,5-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride [71-68-1].
» Hydromorphone Hydrochloride, dried at 105 for 2 hours, contains not less than 98.0 percent and not more than 101.0 percent of C17H19NO3·HCl.
Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
B: Ultraviolet Absorption 197U
Solution: 100 µg per mL.
Medium: water.
Absorptivities at 280 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: A solution (1 in 20) responds to the tests for Chloride 191.
Specific rotation 781S: between 136 and 139.
Test solution: 50 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 VS: not more than 0.30 mL is required to produce a yellow color.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 1.5% of its weight.
Residue on ignition 281: not more than 0.3%.
Sulfate— To a solution of 100 mg in 5 mL of water add 0.5 mL of 3 N hydrochloric acid and 1 mL of barium chloride TS: no turbidity is produced.
Ordinary impurities 466
Test solution: water.
Standard solution: water.
Eluant: a mixture of methylene chloride, methanol, and ammonium hydroxide (80:20:1).
Visualization: 3, followed by overspraying with hydrogen peroxide TS and immediate exposure of the plate to iodine vapors for about 30 minutes.
Assay— Transfer about 225 mg of Hydromorphone Hydrochloride, previously dried and accurately weighed, to a 250-mL conical flask, and dissolve in 80 mL of glacial acetic acid, warming, if necessary. Cool, and add 5 mL of acetic anhydride and 10 mL of mercuric acetate TS. Add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 32.18 mg of C17H19NO3·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 2588
Pharmacopeial Forum: Volume No. 30(4) Page 1254
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.