Sodium Bromide Compounded Oral Solution, Veterinary

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

Sodium Bromide Compounded Oral Solution, Veterinary contains NLT 194.4 mg and NMT 237.6 mg of sodium bromide (NaBr) per mL equivalent to NLT 151 mg and NMT 185 mg of bromide (Br⁻) per mL.

Prepare Sodium Bromide Compounded Oral Solution, Veterinary as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Dissolve the Sodium Bromide in Purified Water. Add Corn Syrup to bring the preparation to final volume with mixing.

2 ASSAY

Procedure

TCA solution: 20% (w/v) trichloroacetic acid in water

Gold chloride solution: 5 mg/mL of gold chloride in water

Standard stock solution: Dissolve USP Sodium Bromide RS in water to obtain a solution with a nominal concentration of 20 mg/mL of bromide.

Standard solutions: Prepare four solutions of known concentrations of about 2.0, 1.0, 0.5, and 0.25 mg/mL of bromide from Standard stock solution in water.

Sample solution: Dilute Oral Solution, Veterinary quantitatively with water (1:99).

Blank: Water

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: Vis

Analytical wavelength: 440 nm

System suitability

Samples: Standard solutions and Blank

Suitability requirements

Correlation coeficient: NLT 0.99, linear regression of the Standard solutions

Analysis

Samples: Sample solution and Blank

To 750-μL aliquots of each Sample add 500 μL of TCA solution and 250 μL of Gold chloride solution. Mix on a vortex mixer, and immediately read the absorbance of each Sample.

Calculate the concentration of bromide (Br⁻), in mg/mL, in the portion of Oral Solution, Veterinary taken:

Result = C × D

C = concentration of the Sample solution (mg/mL) calculated from the standard curve

D = dilution factor of the Sample solution (100)

Acceptance criteria: 151–185 mg/mL of bromide (Br⁻)

3 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in a tight container, and store in a refrigerator.

Beyond-Use Date: NMT 180 days after the date on which it was compounded when stored in a refrigerator

Labeling: Label to state the Beyond-Use Date. Label to state that it is for veterinary use only.

USP Reference Standards 〈11〉

USP Sodium Bromide RS