Nalorphine Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
C₁₉H₂₁NO₃ · HCl 347.84
Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-(2-propenyl)-(5α,6α)-, hydrochloride.
17-Allyl-7,8-didehydro-4,5α-epoxymorphinan-3,6α-diol hydrochloride CAS RN®: 57-29-4; UNII: 9FPE56Z2TW.
Nalorphine Hydrochloride contains not less than 97.0 percent and not more than 103.0 percent of C₁₉H₂₁NO₃ · HCl, calculated on the dried basis.
1 Packaging and storage
Preserve in tight, light-resistant containers. Store at 25°, excursions permitted between 15° and 30°.
1.1 USP Reference standards 〈11〉
USP Nalorphine Hydrochloride RS
2 Identification
Change to read:
2.1 A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K.
Change to read:
2.2 B: Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
Solution: 100 µg per mL.
Medium: water.
2.3 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%.
3 Assay
Transfer about 25 mg of Nalorphine Hydrochloride, accurately weighed, to a 250-mL volumetric fiask, 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.
