(nal or' feen hye'' droe klor' ide).
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.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 100 µg per mL.
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.
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USP35NF30 Page 3986Pharmacopeial Forum: Volume No. 29(6) Page 1935