Printed on: Thu Feb 09 2023, 12:22:05 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-8690AABC-4A2A-468C-9B04-D62048F76DF7_10_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-Nov-2021 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: jb8de DOI: https://doi.org/10.31003/USPNF_M19080_10_01
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Injection volume: 10 µL
Acetaminophen Oral Suspension System suitability
To view the Notice from the Expert Committee that posted in Sample: Standard solution
conjunction with this accelerated revision, please click Suitability requirements
https://www.uspnf.com/rb-acetaminophen-oral-susp- Column efficiency: NLT 1000 theoretical plates
20211029. Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
DEFINITION Analysis
Acetaminophen Oral Suspension is a suspension of Samples: Standard solution and Sample solution
Acetaminophen in a suitable aqueous vehicle. It contains NLT Calculate the percentage of the labeled amount of
90.0% and NMT 110.0% of the labeled amount of acetaminophen (C8H9NO2) in the portion of Oral
acetaminophen (C8H9NO2). Suspension taken:
IDENTIFICATION Result = (rU/rS) × (CS/CU) × 100
• A. SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared
Spectroscopy: 197K rU = peak response from the Sample solution
Sample: Transfer a volume of Oral Suspension, equivalent rS = peak response from the Standard solution
to 240 mg of acetaminophen, to a separator. Add 50 mL of CS = concentration of USP Acetaminophen RS in the
ethyl acetate, and shake. Filter the ethyl acetate extract Standard solution (mg/mL)
through a funnel containing glass wool and 10 g of CU = nominal concentration of acetaminophen in the
anhydrous sodium sulfate. Collect the filtrate in a beaker, Sample solution (mg/mL)
and evaporate on a steam bath to dryness. Dry the residue
under vacuum over silica gel.

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Acceptance criteria: 90.0%–110.0%
Acceptance criteria: The crystals so obtained meet the
requirements.
Delete the following:
• B. The retention time of the acetaminophen peak of the
Sample solution corresponds to that of the Standard • ▲▲ (RB 1-Nov-2021)
solution, as obtained in the Assay.
ASSAY
• PROCEDURE
Mobile phase: Methanol and water (1:3)
ci PERFORMANCE TESTS
• UNIFORMITY OF DOSAGE UNITS á905ñ
For single-unit containers: Meets the requirements
• DELIVERABLE VOLUME á698ñ
Standard solution: 0.01 mg/mL of USP Acetaminophen RS For multiple-unit containers: Meets the requirements
in Mobile phase
ffi
Sample stock solution: Nominally 0.5 mg/mL of IMPURITIES
acetaminophen prepared as follows. Transfer 100 mg of • 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG
acetaminophen from a volume of Oral Suspension, PRODUCTS á227ñ: Meets the requirements
previously well shaken, to a 200-mL volumetric flask. Add
100 mL of Mobile phase, and shake by mechanical means Delete the following:
for 10 min. Dilute with Mobile phase to volume.
O

▲
Sample solution: Nominally 0.01 mg/mL of ▲ (RB 1-Nov-2021)
acetaminophen from the Sample stock solution in SPECIFIC TESTS
Mobile phase. Pass a portion of this solution through a filter • PH á791ñ: 4.0–6.9
of 0.5-µm pore size or finer, discarding the first 10 mL of
the filtrate. Use the clear filtrate. ADDITIONAL REQUIREMENTS
Chromatographic system • PACKAGING AND STORAGE: Preserve in tight containers, and
(See Chromatography á621ñ, System Suitability.) store at controlled room temperature.
Mode: LC • USP REFERENCE STANDARDS á11ñ
Detector: UV 243 nm USP Acetaminophen RS
Column: 3.9-mm × 30-cm; packing L1 USP 4-Aminophenol RS
Flow rate: 1.5 mL/min

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