Acetaminophen for Effervescent Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Acetaminophen for Effervescent Oral Solution contains, in each 100 g, NLT 5.63 g and NMT 6.88 g of acetaminophen (C₈H₉NO₂).

2 IDENTIFICATION

A. A 10-g portion dissolves, with effervescence, in water when dissolved as directed for the Sample solution in the Assay.

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

C. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201)

Sample solution: Triturate 0.4 g of the powder with 25 mL of methanol, and filter.

Chromatographic system

Developing solvent system: Methylene chloride and methanol (4:1)

Acceptance criteria: Meets the requirements

3 ASSAY

3.1 PROCEDURE

Mobile phase: Methanol and water (1:3)

Standard solution: 0.01 mg/mL of USP Acetaminophen RS in Mobile phase

Sample stock solution: Dissolve 10 g of Acetaminophen for Effervescent Oral Solution in 200 mL of water in a 1000-mL volumetric flask, using gentle heat if necessary, until effervescence subsides, and then dilute with water to volume.

Sample solution: Nominally 0.16 mg/mL of acetaminophen in Mobile phase from the Sample stock solution. Pass a portion of this solution through a filter of 0.5-µm or finer pore size, discarding the first 10 mL of the filtrate.

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 243 nm

Column: 3.9-mm x 30-cm; packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

3.3 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Column efficiency: NLT 1000 theoretical plates

Relative standard deviation: NMT 2.0%

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the quantity, in g, of acetaminophen (C₈H₉NO₂) in 100 g of Acetaminophen for Effervescent Oral Solution taken:

Result = (r_U/r_S) x (C_S/C_U) x (1/F₁) x L x F₂

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Acetaminophen RS in the Standard solution (mg/mL)

C_U = nominal concentration of acetaminophen in the Sample solution (mg/mL)

F₁ = conversion factor, 1000 mg/g

L = label claim (mg/unit)

F₂ = conversion factor, 100, based on the label claim of g of acetaminophen per 100 g of sample

Acceptance criteria: 5.63-6.88 g

4 PERFORMANCE TESTS

MINIMUM FILL (755): Meets the requirements for solids packaged in multiple-unit containers

UNIFORMITY OF DOSAGE UNITS (905): Meets the requirements for solids packaged in single-unit containers

5 IMPURITIES

4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS (227): Meets the requirements

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in air-tight containers, and store at controlled room temperature.

USP REFERENCE STANDARDS (11)

USP Acetaminophen RS