A: Using a quantity of finely powdered Tablets, equivalent to about 2.5 mg of oxycodone, proceed as directed for Identification test A under Oxycodone and Acetaminophen Capsules: the specified results are obtained.

B: The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.

Medium: 0.1 N hydrochloric acid; 900 mL.

Apparatus 2: 50 rpm.

Time: 45 minutes.

Procedure— Determine the amounts of oxycodone (C18H21NO4) and acetaminophen (C8H9NO2) dissolved, employing the procedure set forth in the Assay, making any necessary volumetric adjustments, including adjusting the pH of the solution under test to about 5.5 before injecting.

Tolerances— Not less than 75% (Q) of the labeled amounts of C18H21NO4 and C8H9NO2 is dissolved in 45 minutes.

(Official January 1, 2007)

Solvent mixture, Mobile phase, Oxycodone standard stock solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Oxycodone and Acetaminophen Capsules.

Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of powder, equivalent to about 4.5 mg of oxycodone (C18H21NO4), to a suitable container. Add 150.0 mL of Solvent mixture, and shake by mechanical means for 1 hour. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix. Pass the resulting solution through a membrane filter having a 0.5-µm or finer porosity, discarding the first 10 mL of the filtrate. Use the filtrate as the Assay preparation.

Procedure— Proceed as directed for Procedure in the Assay under Oxycodone and Acetaminophen Capsules. Calculate the quantity, in mg, of oxycodone (C18N21NO4) in the portion of Tablets taken by the formula: in which C is the concentration, in mg per mL, of USP Oxycodone RS in the Standard preparation; and rU and rS are the peak oxycodone responses obtained from the Assay preparation and the Standard preparation, respectively. Calculate the quantity, in mg, of acetaminophen (C8H9NO2) in the portion of Tablets taken by the formula: in which C is the concentration, in mg per mL, of USP Acetaminophen RS in the Standard preparation; and rU and rS are the peak acetaminophen responses obtained from the Assay preparation and the Standard preparation, respectively.