Levorphanol Tartrate
;)
Morphinan-3-ol,17-methyl-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1)(salt),dihydrate.
17-Methylmorphinan-3-ol,tartrate (1:1)(salt)dihydrate [5985-38-6].
Anhydrous 407.47 [125-72-4].
»Levorphanol Tartrate contains not less than 99.0percent and not more than 101.0percent of C17H23NO·C4H6O6,calculated on the anhydrous basis.
Packaging and storage—
Preserve in well-closed containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:Infrared Absorption á197Kñ—
Obtain the test specimen as follows.Dissolve 50mg in 25mLof water in a 125-mLseparator.Add 2mLof 6Nammonium hydroxide,extract with 25mLof chloroform,and filter the chloroform extract through a layer of 4g of granular anhydrous sodium sulfate supported on glass wool into a 125-mLconical flask.Evaporate the chloroform extract on a steam bath with the aid of a stream of nitrogen to dryness.Dissolve the residue in 1mLof acetone,and evaporate to dryness.Dry in vacuum at 90for 1hour.Proceed as directed with the dried levorphanol so obtained and a similar preparation of USP Levorphanol Tartrate RS.
for 1hour.Proceed as directed with the dried levorphanol so obtained and a similar preparation of USP Levorphanol Tartrate RS.
B:Ultraviolet Absorption á197Uñ—
Solution:
130µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 279nm,calculated on the anhydrous basis,do not differ by more than 3.0%.
Specific rotation á781Sñ:
between -14.7and -16.3.
and -16.3.
Test solution:
30mg per mL,in water.Heat on a water bath or sonicate to dissolve 750mg in 20mLof water in a 25-mLvolumetric flask,dilute with water to volume,and mix.
Water,Method Iá921ñ:
between 7.0%and 9.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
water.
Standard solution:
water.
Eluant:
a mixture of hexanes,dehydrated alcohol,and ammonium hydroxide (80:25:1).
Visualization:
17;then view immediately under short-wavelength UVlight.
Assay—
Transfer about 250mg of Levorphanol Tartrate,accurately weighed,to a 250-mLflask,add 25mLof dehydrated alcohol,and warm slightly to dissolve.Add 100mLof chloroform,then add 4drops of methanolic methyl red TS,and titrate with 0.02Nperchloric acid in dioxane VSto a red endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.02Nperchloric acid is equivalent to 8.149mg of C17H23NO·C4H6O6.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1125
Pharmacopeial Forum:Volume No.29(6)Page 1916
Phone Number:1-301-816-8143