Pseudoephedrine Hydrochloride

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

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

DOWNLOAD PDF HERE

C₁₀H₁₅NO . HCl 201.69

Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride;

(+)-Pseudoephedrine hydrochloride CAS RN^®: 345-78-8; UNII: 6V9V2RYJ8N

1 DEFINITION

Pseudoephedrine Hydrochloride contains NLT 98.0% and NMT 102.0% of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

B. Identification Tests—General, Chloride 〈191〉: Meets the requirements

3 ASSAY

Change to read:

3.1 Procedure

Triethylamine–phosphoric acid solution: Mix 5 mL of triethylamine with 1 L of water. Adjust with phosphoric acid to a pH of 6.8.

Mobile phase: Methanol and Triethylamine–phosphoric acid solution (10:90)

System suitability solution: 0.1 mg/mL of USP Pseudoephedrine Hydrochloride RS and 0.002 mg/mL of USP Ephedrine Sulfate RS in water

Standard solution: 0.1 mg/mL of USP Pseudoephedrine Hydrochloride RS in water

Sample solution: 0.1 mg/mL of pseudoephedrine hydrochloride in water

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 206 nm

Column: 3.0-mm × 15-cm; packing L11

Flow rate: 0.6 mL/min

Injection volume: 10 µL

System suitability

Sample: System suitability solution

[Note—The relative retention times for ephedrine and pseudoephedrine are approximately 0.9 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2 between the pseudoephedrine and ephedrine peaks

Tailing factor: NMT 2.0 for the pseudoephedrine peak

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of pseudoephedrine hydrochloride (C₁₀H₁₅NO . HCl) in the portion of Pseudoephedrine Hydrochloride 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 = concentration of Pseudoephedrine Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Organic Impurities

Sample solution: Proceed as directed in the Assay.

Analysis: Using the chromatogram of the Sample solution, calculate the percentage of each impurity in the portion of Pseudoephedrine Hydrochloride taken:

Result = (r_U/r_T) × 100

r_U = peak response for each impurity

r_T = sum of all the peak responses

Acceptance criteria: NMT 2.0%, total impurities

5 SPECIFIC TESTS

Melting Range or Temperature, Class I 〈741〉: 182°–186°. The range between beginning and end of melting does not exceed 2°.

Optical Rotation, Specific Rotation 〈781S〉

Sample solution: 50 mg/mL

Acceptance criteria: +61.0° to +62.5°

pH 〈791〉: 4.6–6.0, in a 50-mg/mL solution

Loss on Drying 〈731〉

Analysis: Dry a sample at 105° for 3 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

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

USP Reference Standards 〈11〉

USP Ephedrine Sulfate RS

USP Pseudoephedrine Hydrochloride RS