Oxycodone and Acetaminophen Tablets, chemical structure, molecular formula, Reference Standards

Oxycodone and Acetaminophen Tablets

»Oxycodone and Acetaminophen Tablets contain Oxycodone Hydrochloride and Acetaminophen.Tablets contain the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of oxycodone (C18H21NO4),and not less than 90.0percent and not more than 110.0percent 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 1.116mg of oxycodone hydrochloride.

USP Reference standards á11ñ— USP Acetaminophen RS.USP Oxycodone RS.

Identification—

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

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

Dissolution,Procedure for a Pooled Sample á711ñ—

Medium: 0.1Nhydrochloric acid;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

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 pHof the solution under test to about 5.5before injecting.

Tolerances— Not less than 75%(Q)of the labeled amounts of C18H21NO4and C8H9NO2is dissolved in 45minutes.

Uniformity of dosage units á905ñ: meet the requirements for Content Uniformitywith respect to oxycodone and for Weight Variationwith respect to acetaminophen.

Assay—

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

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

Procedure— Proceed as directed for Procedurein the Assayunder 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 Cis the concentration,in mg per mL,of USP Oxycodone RSin the Standard preparation;and rUand rSare the peak oxycodone responses obtained from the Assay preparationand 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 Cis the concentration,in mg per mL,of USP Acetaminophen RSin the Standard preparation;and rUand rSare the peak acetaminophen responses obtained from the Assay preparationand the Standard preparation,respectively.

Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 1439

Pharmacopeial Forum:Volume No.30(1)Page 151

Phone Number:1-301-816-8143