Oxycodone and Acetaminophen Tablets
» Oxycodone and Acetaminophen Tablets contain Oxycodone Hydrochloride and Acetaminophen. Tablets contain the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of oxycodone (C18H21NO4), and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of acetaminophen (C8H9NO2).
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The Tablets may be labeled to indicate the content of oxycodone hydrochloride (C18H21NO4·HCl) equivalent. Each mg of oxycodone is equivalent to 1.116 mg of oxycodone hydrochloride.
USP Reference standards 11—
USP Acetaminophen RS Click to View Structure
USP Oxycodone RS Click to View Structure
Identification—
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.
Dissolution, Procedure for a Pooled Sample 711—
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.
Uniformity of dosage units 905: meet the requirements for Content Uniformity with respect to oxycodone and for Weight Variation with respect to acetaminophen.
Assay—
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:
1500C(rU / rS)
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:
1500C(rU / rS)
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
1-301-816-8139		 (SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106		 (GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 4176
Pharmacopeial Forum: Volume No. 37(4)