Pseudoephedrine Hydrochloride Tablets

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 Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl).

2 IDENTIFICATION

A. Thin-Layer Chromatographic Identification Test 〈201〉

Standard solution: 3 mg/mL of USP Pseudoephedrine Hydrochloride RS in water

Sample solution: Shake or mix 1 Tablet in 10 mL of water until the Tablet completely disintegrates. Sonicate for 5 min, centrifuge for 5 min, and pass through a nylon filter.

Chromatographic system

Developing solvent system: Butyl alcohol, glacial acetic acid, and water (8:2:2)

Analysis: Proceed as directed in the chapter.

Acceptance criteria: The R_F value and appearance of the principal spot from the Sample solution correspond to that from the Standard solution.

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

3 ASSAY

3.1 Procedure

Mobile phase: Alcohol and 0.40% ammonium acetate solution (17:3)

Standard solution: 1.2 mg/mL of USP Pseudoephedrine Hydrochloride RS in 0.01 N hydrochloric acid

Sample solution: Nominally 1.2 mg/mL of pseudoephedrine hydrochloride in 0.01 N hydrochloric acid, prepared by transferring an appropriate amount of the contents of NLT 20 Tablets to a suitable volumetric flask and dissolving in 0.01 N hydrochloric acid by sonicating. Cool to room temperature, dilute with 0.01 N hydrochloric acid to volume, and filter.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; packing L3

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% from five replicate injections

Analysis

Samples: Standard solution and Sample solution

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

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response 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)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

4.1 Dissolution, Procedure for a Pooled Sample 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Mobile phase: Alcohol and 0.40% ammonium acetate solution (17:3)

Standard solution: USP Pseudoephedrine Hydrochloride RS of a known concentration similar to that of the Sample solution, in Medium

Sample solution: Filtered portion of sample suitably diluted with Medium

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 214 nm

Column: 4.6-mm × 25-cm; packing L3

Flow rate: 1.5 mL/min

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% from five replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl) dissolved.

Tolerances: NLT 75% (Q) of the labeled amount of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl) is dissolved.

Change to read:

4.2 Uniformity of Dosage Units 〈905〉: Meets the requirements (ERR 1-May-2023)

Procedure for content uniformity, chewable tablets only (ERR 1-May-2023)

Mobile phase: Alcohol and 0.40% ammonium acetate solution (17:3)

Standard solution: 0.15 mg/mL of USP Pseudoephedrine Hydrochloride RS in a mixture of methanol and 0.01 N hydrochloric acid (1:4)

Sample solution: Transfer 1 Tablet to a 100-mL volumetric flask, add 20 mL of methanol, and shake for 30 min. Add 25 mL of 0.01 N hydrochloric acid, and sonicate to dissolve. Cool to room temperature, dilute with 0.01 N hydrochloric acid to volume, and filter.

Chromatographic system and System suitability: Proceed as directed in the Assay.

Analysis

Samples: Standard solution and Sample solution

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

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response 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)

(ERR 1-May-2023)

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Pseudoephedrine Hydrochloride RS