Acetaminophen for Effervescent Oral Solution
»Acetaminophen for Effervescent Oral Solution contains,in each 100g,not less than 5.63g and not more than 6.88g of acetaminophen (C8H9NO2).
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
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.
C: Triturate about 0.4g of the powder with 25mLof methanol,and filter: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.
Minimum fill á755ñ
FOR SOLID PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Uniformity of dosage units á905ñ
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
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 (C8H9NO2)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.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 18
Pharmacopeial Forum:Volume No.27(3)Page 2495
Phone Number:1-301-816-8139