Acetaminophen Oral Solution
»Acetaminophen Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of acetaminophen (C8H9NO2).
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Identification—
A: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
B: Dilute a portion of Oral Solution with methanol to obtain a solution containing about 1mg of acetaminophen per mL.This test solution responds to the Thin-Layer Chromatographic Identification Test á201ñ,a solvent system consisting of a mixture of methylene chloride and methanol (4:1)being used.
Add the following:
Uniformity of dosage units á905ñ
for oral solution packaged in single-unit containers: meets the requirements.USP28
Add the following:
Deliverable volume á698ñ
for oral solution packaged in multiple-unit containers: meets the requirements.USP28
pHá791ñ: between 3.8and 6.1.
Alcohol content (if present),Method IIá611ñ: between 90.0%and 115.0%of the labeled amount of C2H5OH,determined by the gas–liquid chromatographic procedure,acetone being used as the internal standard.
Assay
Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Acetaminophen Capsules.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 500mg of acetaminophen,to a 250-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer 5.0mLof this solution to a second 250-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer 25.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Pass a portion of this solution through a filter having a 0.5-µm or finer porosity,discarding the first 10mLof the filtrate.Use the clear filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Acetaminophen Capsules.Calculate the quantity,in mg,of acetaminophen (C8H9NO2)in each mLof the Oral Solution taken by the formula:
50,000(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Acetaminophen RSin the Standard preparation;Vis the volume,in mL,of Oral Solution taken;and rUand rSare the acetaminophen peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 17
Pharmacopeial Forum:Volume No.30(1)Page 40
Phone Number:1-301-816-8139