Nalorphine Hydrochloride
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]. » Nalorphine Hydrochloride contains not less than 97.0 percent and not more than 103.0 percent of C19H21NO3·HCl, calculated on the dried basis.
Packaging and storage
Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
Identification
C:
A solution of it responds to the tests for Chloride 191.
Specific rotation 781S:
between 122 and 125.
Test solution:
20 mg per mL, in water.
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%.
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:
0.25C(AU / AS)
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3026
Pharmacopeial Forum: Volume No. 29(6) Page 1935
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