Potassium 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

Potassium Bromide Compounded Oral Solution, Veterinary contains NLT 225 mg and NMT 275 mg of potassium bromide (KBr) per mL, equivalent to NLT 151 mg and NMT 185 mg of bromide (Br⁻) per mL.

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

Dissolve the Potassium Bromide in Purified Water. Add Corn Syrup, FCC, to bring to nal 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 by diluting the Standard stock solution with water.

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

Blank: Water

2.1 Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: Vis

Analytical wavelength: 440 nm

2.2 System suitability

Samples: Standard solutions and Blank

Suitability requirements

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

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

Result = C × D

C = concentration of the Sample solution (mg/mL) obtained 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 it to state the Beyond-Use Date. Label it to indicate that it is for veterinary use only.

USP Reference Standards 〈11〉

USP Sodium Bromide RS