Acetaminophen Oral Solution
» Acetaminophen Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of acetaminophen (C8H9NO2).
Packaging and storage Preserve in tight containers, and store at controlled room temperature.
USP Reference standards 11
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds 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 1 mg of acetaminophen per mL. This test solution responds to the Thin-Layer Chromatographic Identification Test 201, a solvent system consisting of a mixture of methylene chloride and methanol (4:1) being used.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers: meets the requirements.
pH 791: between 3.8 and 6.1.
Alcohol content (if present), Method II 611: between 90.0% and 115.0% of the labeled amount of C2H5OH, determined by the gasliquid chromatographic procedure, acetone being used as the internal standard.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Acetaminophen Capsules.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 500 mg of acetaminophen, to a 250-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 5.0 mL of this solution to a second 250-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 25.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Pass a portion of this solution through a filter having a 0.5-µm or finer porosity, discarding the first 10 mL of the filtrate. Use the clear filtrate as the Assay preparation.
Procedure Proceed as directed for Procedure in the Assay under Acetaminophen Capsules. Calculate the quantity, in mg, of acetaminophen (C8H9NO2) in each mL of the Oral Solution taken by the formula:
50,000(C/V)(rU / rS)in which C is the concentration, in mg per mL, of USP Acetaminophen RS in the Standard preparation; V is the volume, in mL, of Oral Solution taken; and rU and rS are the acetaminophen peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2031Pharmacopeial Forum: Volume No. 30(1) Page 40