C19H21NO3·HCl 347.84

Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-(2-propenyl)-(5,6)-, hydrochloride.
17-Allyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol hydrochloride [57-29-4].

Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.

USP Reference standards 11— USP Nalorphine Hydrochloride RS.

Identification—

Specific rotation 781S: between 122 and 125.

Loss on drying 731— Dry it in vacuum at 100 for 2 hours: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.1%.

Residual solvents 467: meets the requirements.

Assay— Transfer about 25 mg of Nalorphine Hydrochloride, accurately weighed, to a 250-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Concomitantly determine the absorbances of this solution and of a Standard solution of USP Nalorphine Hydrochloride RS in the same medium having a known concentration of about 100 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 285 nm, with a suitable spectrophotometer, using water as the blank. Calculate the quantity, in mg, of C19H21NO3·HCl in the Nalorphine Hydrochloride taken by the formula: in which C is the concentration, in µg per mL, of USP Nalorphine Hydrochloride RS in the Standard solution; and AU and AS are the absorbances of the solution of Nalorphine Hydrochloride and the Standard solution, respectively.

Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 1474

Phone Number : 1-301-816-8139