Nalorphine Hydrochloride
;)
Morphinan-3,6-diol,7,8-didehydro-4,5-epoxy-17-(2-propenyl)-(5a,6a)-,hydrochloride.
17-Allyl-7,8-didehydro-4,5a-epoxymorphinan-3,6a-diol hydrochloride [57-29-4].
»Nalorphine Hydrochloride contains not less than 97.0percent and not more than 103.0percent of C19H21NO3·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
C:
Asolution of it responds to the tests for Chloride á191ñ.
Specific rotation á781Sñ:
between -122and -125.
and -125.
Test solution:
20mg per mL,in water.
Loss on drying á731ñ—
Dry it in vacuum at 100for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Assay—
Transfer about 25mg of Nalorphine Hydrochloride,accurately weighed,to a 250-mLvolumetric 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 RSin the same medium having a known concentration of about 100µg per mLin 1-cm cells at the wavelength of maximum absorbance at about 285nm,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 Cis the concentration,in µg per mL,of USP Nalorphine Hydrochloride RSin the Standard solution;and AUand ASare the absorbances of the solution of Nalorphine Hydrochloride and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1327
Pharmacopeial Forum:Volume No.29(6)Page 1935
Phone Number:1-301-816-8143