Acetaminophen Oral Suspension
»Acetaminophen Oral Suspension is a suspension of Acetaminophen in a suitable aqueous vehicle.It 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— Transfer a volume of Oral Suspension,equivalent to about 240mg of acetaminophen,to a separator,add 50mLof ethyl acetate,and shake.Filter the ethyl acetate extract through a funnel containing glass wool and about 10g of anhydrous sodium sulfate.Collect the filtrate in a beaker,and evaporate on a steam bath to dryness.Dry the residue in vacuum over silica gel:the crystals so obtained respond to Identificationtest Aunder Acetaminophen.
Add the following:
Uniformity of dosage units á905ñ—
FOR ORAL SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.USP28
Add the following:
Deliverable volume á698ñ—
FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.USP28
pHá791ñ: between 4.0and 6.9.
Assay—
Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Acetaminophen Capsules.
Assay preparation— Transfer an accurately measured volume of Oral Suspension,previously well-shaken,equivalent to about 100mg of acetaminophen,to a 200-mLvolumetric flask,add about 100mLof Mobile phase,and shake by mechanical means for 10minutes.Dilute with Mobile phaseto volume,and mix.Transfer 5.0mLof this solution to a 250-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 Suspension taken by the formula:
10,000(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 Suspension 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 18
Pharmacopeial Forum:Volume No.30(5)Page 1579
Phone Number:1-301-816-8139