Identification
A:
A10-g portion dissolves,with effervescence,in 200mLof water when performed as directed for the Assay preparationin the Assay.
B:
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.
Assay
Mobile phase,Standard preparation,and Chromatographic system
Proceed as directed in the
Assayunder
Acetaminophen Capsules.
Assay preparation
Dissolve about 10g of Acetaminophen for Effervescent Oral Solution,accurately weighed,in about 200mLof water in a 1000-mLvolumetric flask,using gentle heat if necessary,until effervescence subsides,then dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 8.0mLof this solution to a 50-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 g,of acetaminophen (C
8H
9NO
2)in the portion of Acetaminophen for Effervescent Oral Solution taken by the formula:
62.5C(rU/rS),
in which
Cis the concentration,in mg per mL,of
USP Acetaminophen RSin the
Standard preparation;and
rUand
rSare the acetaminophen peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.