Levorphanol Tartrate Injection
» Levorphanol Tartrate Injection is a sterile solution of Levorphanol Tartrate in Water for Injection. It contains not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C17H23NO.C4H6O6·2H2O.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin RS
A: To 1 mL of Injection add 1 drop of 3 N hydrochloric acid and 2 drops of ferric chloride TS. Heat to boiling, and add 1 mL of potassium ferricyanide solution (1 in 200): a blue-green color develops.
B: The angular rotation of the Injection is levorotatory (see Optical Rotation 781).
Bacterial endotoxins 85 It contains not more than 125.0 USP Endotoxin Units per mg of levorphanol tartrate.
pH 791: between 4.1 and 4.5.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 40 mg of levorphanol tartrate, to a 125-mL separator. Add 5 g of sodium chloride and sufficient sodium bicarbonate to render the solution alkaline to litmus, add an additional 100 mg of sodium bicarbonate, and extract the levorphanol with five 20-mL portions of a mixture of 3 volumes of ether and 1 volume of chloroform. Pass the combined extracts through a layer of about 10 g of granular anhydrous sodium sulfate into a 500-mL conical flask, and evaporate to a volume of about 30 mL. Add about 50 mL of chloroform and 1 drop of methanolic methyl red TS, and titrate with 0.01 N perchloric acid in dioxane VS to a red endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.01 N perchloric acid is equivalent to 4.435 mg of C17H23NO·C4H6O6·2H2O.
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Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
(SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
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USP35–NF30 Page 3676