Sodium Bromide Compounded Injection, 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 Injection, Veterinary contains NLT 27 mg and NMT 33 mg of Sodium Bromide (NaBr) per mL, equivalent to NLT 21.0 mg and NMT 25.6 mg of bromide (Br⁻) per mL.

Prepare Sodium Bromide Compounded Injection, Veterinary as follows (see Pharmaceutical Compounding—Sterile Preparations 〈797〉).

Sodium Bromide 3.0 g

Sterile Water for Injection, USP, a suficient quantity to make 100 mL

Dissolve the Sodium Bromide in Sterile Water for Injection with mixing. Sterilize by a suitable means such as sterile filtration or autoclaving.

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 and water.

Sample solution: Dilute Injection, Veterinary quantitatively with water (1:19).

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 Injection, 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 (20)

Acceptance criteria: 21.0–25.6 mg/mL of bromide (Br⁻)

3 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 0.03 USP Endotoxin Units/mg of sodium bromide

Sterility Tests 〈71〉: Meets the requirements

Other Requirements: It meets the requirements in Labeling 〈7〉, Labels and Labeling for Injectable Products.

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in single-dose containers, preferably of Type I glass, and store in a refrigerator.

Change to read:

Beyond-Use Date: In the absence of performing and completing a sterility and endotoxin test, the storage conditions in Pharmaceutical

Compounding – Sterile Preparations 〈797〉, 14.3 Establishing a BUD for a CSP apply. (CN 1-Nov-2023) After successful completion of sterility and endotoxin testing, 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 infusion only at a rate not to exceed 150 mg of sodium bromide per kg of body weight per hour. Label to state that it is for veterinary use only.

USP Reference Standards 〈11〉

USP Sodium Bromide RS