Nalorphine Hydrochloride

(nal or' feen hye'' droe klor' ide).

C19H21NO3·HCl

347.84

Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-(2-propenyl)-(5

)-, 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

—

USP Nalorphine Hydrochloride RS

Identification—

A: Infrared Absorption

197K

B: Ultraviolet Absorption

197U

—

Solution: 100 µg per mL.

Medium: water.

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.

Topic/Question	Contact	Expert Committee
Monograph	Clydewyn M. Anthony, Ph.D. Senior Scientific Liaison 1-301-816-8139	(SM22010) Monographs - Small Molecules 2
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 3986

Pharmacopeial Forum: Volume No. 29(6) Page 1935