Levorphanol Tartrate Injection
»Levorphanol Tartrate Injection is a sterile solution of Levorphanol Tartrate in Water for Injection.It contains not less than 93.0percent and not more than 107.0percent of the labeled amount of C17H23NO.C4H6O6·2H2O.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification—
A: To 1mLof Injection add 1drop of 3Nhydrochloric acid and 2drops of ferric chloride TS.Heat to boiling,and add 1mLof potassium ferricyanide solution (1in 200):a blue-green color develops.
B: The angular rotation of the Injection is levorotatory (see Optical Rotation á781ñ).
Bacterial endotoxins á85ñ— It contains not more than 125.0USP Endotoxin Units per mg of levorphanol tartrate.
pHá791ñ: between 4.1and 4.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 40mg of levorphanol tartrate,to a 125-mLseparator.Add 5g of sodium chloride and sufficient sodium bicarbonate to render the solution alkaline to litmus,add an additional 100mg of sodium bicarbonate,and extract the levorphanol with five 20-mLportions of a mixture of 3volumes of ether and 1volume of chloroform.Pass the combined extracts through a layer of about 10g of granular anhydrous sodium sulfate into a 500-mLconical flask,and evaporate to a volume of about 30mL.Add about 50mLof chloroform and 1drop of methanolic methyl red TS,and titrate with 0.01Nperchloric acid in dioxane VSto a red endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.01Nperchloric acid is equivalent to 4.435mg of C17H23NO·C4H6O6·2H2O.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1126
Phone Number:1-301-816-8143