Printed on: Wed Jan 06 2021, 03:38:43 AM Official Status: Currently Official on 06-Jan-2021 DocId: 1_GUID-ABAFA796-6721-4769-8BAE-A3BF1946E0D1_2_en-US (EST) Printed by: Jinjiang Yang Official Date: Official Prior to 2013 @2021 USPC 1

Sample solution: Pass a portion of the solution under test Levorphanol Tartrate Tablets through a filter and suitably dilute with water. DEFINITION Instrumental conditions Levorphanol Tartrate Tablets contain NLT 93.0% and NMT Mode: UV 107.0% of the labeled amount of levorphanol tartrate Analytical wavelength: Maximum absorbance at about (C H NO · C H O · 2H O). 279 nm 17 23 4 6 6 2 Analysis IDENTIFICATION Samples: Standard solution and Sample solution • A. Determine the percentage of levorphanol tartrate Sample: Nominally equivalent to about 1 mg of levorphanol (C17H23NO · C4H6O6 · 2H2O) dissolved by comparing tartrate from a number of finely powdered Tablets the UV absorbances between the Standard solution and Analysis: To the Sample, add 1 mL of water, 1 drop of 3 N Sample solution. hydrochloric acid, and 2 drops of ferric chloride TS, and Tolerances: NLT 75% (Q) of the labeled amount of heat to boiling. To the hot solution, add 1 mL of potassium levorphanol tartrate (C17H23NO · C4H6O6 · 2H2O) is ferricyanide solution (1 in 200). dissolved. Acceptance criteria: A bluish color develops. ● UNIFORMITY OF DOSAGE UNITS á905ñ ●B. Procedure for content uniformity Sample solution: Powder a number of Tablets, equivalent Diluent: 0.1 N hydrochloric acid to about 60 mg of levorphanol tartrate, and transfer the Standard solution: USP Levorphanol Tartrate RS in mixture to a small separator. Add 10 mL of water, dissolve Diluent having a known concentration of about 80 as much of the powder as possible, add about 400 mg of µg/mL of anhydrous levorphanol tartrate sodium bicarbonate, and extract with a 50-mL portion of Sample solution: Nominally about 80 ug/mL of chloroform. Evaporate the filtered chloroform extract on a levorphanol tartrate in Diluent prepared as follows. steam bath to a small volume, and dilute with chloroform Transfer 1 Tablet to a glass-stoppered flask, add to 10 mL. 25.0 mL of Diluent, and allow the Tablet to disintegrate. Analysis: Determine the angular rotation of the Sample Shake well, filter through a small filter paper, and discard solution (see Optical Rotation á781ñ). the first portion of the filtrate. Dilute a portion of the Acceptance criteria: The Sample solution is levorotatory. filtrate quantitatively and stepwise, if necessary. Instrumental conditions ASSAY Mode: UV ● PROCEDURE Analytical wavelength: Maximum absorbance at Sample solution: Weigh and finely powder Tablets (NLT about 279 nm 20). Transfer an amount nominally equivalent to about Blank: Diluent 40 mg of levorphanol tartrate to a 125-mL separator. Add Cell: 1 cm 20 mL of water and sufficient sodium bicarbonate to Analysis render the suspension alkaline to litmus. Add an additional Samples: Standard solution and Sample solution 100 mg of sodium bicarbonate, and extract the Calculate the percentage of the labeled amount of levorphanol with five 20-mL portions of a mixture of 3 levorphanol tartrate (C H NO · C H O · 2H O) in volumes of ether and 1 volume of chloroform. Pass the 17 23 4 6 6 2 combined extracts through a layer of about 10 g of the portion of Tablets taken: granular sodium sulfate, anhydrous into a 500-mL conical Result = (A /A ) x (C /C ) x (M /M ) x 100 flask, and evaporate to a volume of about 30 mL. U S S U r1 r2 Titrimetric system A = absorbance of the Sample solution Mode: Direct titration U OfficialAS = absorbance of the Standard solution Titrant: 0.01 N perchloric acid in dioxane VS End point detection: Visual CS = concentration of USP Levorphanol Tartrate RS, on Analysis: To the Sample solution, add about 50 mL of the anhydrous basis, in the Standard solution (µg/ chloroform and 1 drop of methyl red TS, methanolic. mL) Titrate with the Titrant to a red endpoint. Perform a blank CU = nominal concentration of levorphanol tartrate in determination, and make any necessary correction. Each the Sample solution (µg/mL) milliliter of 0.01 N perchloric acid is equivalent to Mr1 = molecular weight of the hydrated form of 4.435 mg of levorphanol tartrate (C H NO · C H O · levorphanol tartrate, 443.49 17 23 4 6 6 M = molecular weight of the anhydrous form of 2H O). r2 2 levorphanol tartrate, 407.47 Acceptance criteria: 93.0%–107.0% PERFORMANCE TESTS Acceptance criteria: Meet the requirements ● DISSOLUTION á711ñ ADDITIONAL REQUIREMENTS Medium: Water; 500 mL ● PACKAGING AND STORAGE: Preserve in well-closed Apparatus 2: 50 rpm containers. Time: 30 min ● USP REFERENCE STANDARDS á11ñ Standard solution: A known concentration of USP USP Levorphanol Tartrate RS Levorphanol Tartrate RS in Medium

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