Arginine Hydrochloride Compounded 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

Arginine Hydrochloride Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of arginine hydrochloride (C₆H₁₄N₄O₂.HCI).

Prepare Arginine Hydrochloride Compounded Oral Solution 100 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

In an appropriately sized container, add the Methylparaben and Propylparaben to about 80 mL of Purified Water. Stir until dissolved. [NOTE-May heat up to 50° to facilitate dissolution.] Dissolve the Arginine Hydrochloride powder in the previously prepared solution of Methylparaben and Propylparaben. Bring to final volume with Purified Water.

2 ASSAY

2.1 PROCEDURE

Solution A: 20 mM ammonium acetate solution adjusted with glacial acetic acid to a pH of 6

Mobile phase: Acetonitrile and Solution A (22:78). Pass through a membrane filter of 0.22-µm pore size.

Standard solution: 0.5 mg/mL of arginine hydrochloride prepared from USP Arginine Hydrochloride RS in water

Sample solution: Transfer 1 mL of Oral Solution to a 200-mL volumetric flask, add approximately 160 mL of water, and vortex. Dilute with water to volume and mix.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 15-cm; 5-µm packing L10

Temperatures

Autosampler: 4°

Column: 30°

Flow rate: 1 mL/min

Injection volume: 60 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for arginine hydrochloride is about 5.4 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of arginine hydrochloride (C₆H₁₄N₄O₂.HCI) in the portion of Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of arginine hydrochloride from the Sample solution

r_S = peak response of arginine hydrochloride from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 5.0-6.0

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature.

BEYOND-USE DATE: NMT 90 days after the date on which it was compounded when stored in a refrigerator or at controlled room temperature

LABELING: Label it to state the Beyond-Use Date.

USP REFERENCE STANDARDS (11)

USP Arginine Hydrochloride RSA (USP 1-May-2020)