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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.
Identification
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
Uniformity of dosage units
for oral solution packaged in single-unit containers:
meets the requirements.
Deliverable volume
for oral solution packaged in multiple-unit containers:
meets the requirements.
pH
Alcohol content (if present), Method II
Assay
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1389
Pharmacopeial Forum: Volume No. 30(1) Page 40
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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