Pseudoephedrine Hydrochloride 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

Pseudoephedrine Hydrochloride Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl).

2 IDENTIFICATION

Change to read:

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Dec-2020)

Change to read:

B.

Sample solution: 5 mg/mL of pseudoephedrine from a volume of Oral Solution equivalent to 120 mg of pseudoephedrine hydrochloride (USP 1-Dec-2020) in 0.1 N hydrochloric acid

Acceptance criteria: The Sample solution is dextrorotatory.

3 ASSAY

Change to read:

3.1 Procedure

Solution A: 0.1 M potassium phosphate, 1.0% triethylamine, and 0.4% phosphoric acid in a mixture of methanol and water (10:90) prepared as follows. Dissolve 17.4 g of potassium phosphate dibasic in 800 mL of a mixture of methanol and water (10:90) into a 1-L volumetric flask. Pipet 10.0 mL of triethylamine and 4.0 mL of phosphoric acid into the flask. Dilute with a mixture of methanol and water (10:90) to volume.

Solution B: 0.1 M potassium phosphate, 1.0% triethylamine, and 0.4% phosphoric acid in a mixture of methanol and water (50:50) prepared as follows. Dissolve 17.4 g of potassium phosphate dibasic in 800 mL of a mixture of methanol and water (50:50) into a 1-L volumetric flask. Pipet 10.0 mL of triethylamine and 4.0 mL of phosphoric acid into the flask. Dilute with a mixture of methanol and water (50:50) to volume.

Mobile phase: See Table 1.

Table 1

Standard solution: 0.3 mg/mL each of USP Pseudoephedrine Hydrochloride RS and USP Sodium Benzoate RS in water

Sample solution: Nominally 0.3 mg/mL of pseudoephedrine hydrochloride in water. Prepare by adding a suitable amount of Oral Solution to an appropriate flask and diluting with water to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 257 nm

Column: 3.0-mm × 10-cm; 1.8-µm packing L1

Column temperature: 50°

Flow rate: 0.25 mL/min

Injection volume: 7 µL

System suitability

Sample: Standard solution

[Note—The relative retention times for sodium benzoate and pseudoephedrine are 0.85 and 1.00, respectively.]

Suitability requirements

Resolution: NLT 2.0 between sodium benzoate and pseudoephedrine

Relative standard deviation: NMT 2.0% for both sodium benzoate and pseudoephedrine

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl) in the portion of Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of pseudoephedrine from the Sample solution

r_S = peak response of pseudoephedrine from the Standard solution

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

C_U = nominal concentration of pseudoephedrine hydrochloride in the Sample solution (mg/mL) (USP 1-Dec-2020)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

4.1 Uniformity of Dosage Units 〈905〉

For Oral Solution packaged in single-unit containers

Acceptance criteria: Meets the requirements

4.2 Deliverable Volume 〈698〉

For Oral Solution packaged in multiple-unit containers

Acceptance criteria: Meets the requirements

5 IMPURITIES

Add the following:

5.1 Organic Impurities

Solution A, Solution B, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Standard stock solution: Prepare as directed for the Standard solution in the Assay.

Standard solution: 0.6 µg/mL each of USP Pseudoephedrine Hydrochloride RS and USP Sodium Benzoate RS in water from the Standard stock solution

Sensitivity solution: 0.3 µg/mL each of USP Pseudoephedrine Hydrochloride RS and USP Sodium Benzoate RS in water from the Standard stock solution

System suitability

Samples: Standard solution and Sensitivity solution

Suitability requirements

Resolution: NLT 2.0 between sodium benzoate and pseudoephedrine, Standard solution

Relative standard deviation: NMT 6.0% for sodium benzoate, Standard solution

Signal-to-noise ratio: NLT 10 for sodium benzoate, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of any unspecified degradation product in the portion of Oral Solution taken:

Result =  (r_U/r_S) × (C_S/C_U) × (1/F) × 100

r_U = peak response of any unspecified degradation product from the Sample solution

r_S = peak response of sodium benzoate from the Standard solution

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

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

F = relative response factor for sodium benzoate, 0.12

Acceptance criteria: See Table 2.

Table 2

6 SPECIFIC TESTS

Change to read:

Reaction

Sample: Oral Solution (USP 1-Dec-2020)

Acceptance criteria: It is acid to litmus.

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

Change to read:

USP Reference Standards 〈11〉

USP Pseudoephedrine Hydrochloride RS

USP Sodium Benzoate RS (USP 1-Dec-2020)