Potassium Bromide Oral Solution, Veterinary
DEFINITION
Potassium Bromide Oral Solution, Veterinary contains an amount of potassium bromide equivalent to NLT 151 mg and NMT 185 mg of bromide (Br
) per mL.
) per mL.Prepare Potassium Bromide Oral Solution, Veterinary as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).| Potassium Bromide
|
25 g |
| Purified Water | 60 mL |
| Corn Syrup, FCC, a sufficient quantity to make | 100 mL |
Dissolve the Potassium Bromide in Purified Water. Add Corn Syrup to bring to final volume with mixing.
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 4 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
Instrumental conditions
Mode:
Vis
Analytical wavelength:
440 nm
System suitability
Samples:
Standard solutions and Blank
Suitability requirements
Correlation coefficient:
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, in mg/mL, of bromide (Br) in the portion of Oral Solution, Veterinary taken:
) 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)
)
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in a tight container, and store in a refrigerator.
• Labeling:
Label to state that it is to be kept out of the reach of children. Label it to state the Beyond-Use Date, and the nominal content of potassium bromide in the Oral Solution, Veterinary. Label it to indicate that it is for veterinary use only.
• Beyond-Use Date:
NMT 180 days after the date on which it was compounded.
• USP Reference Standards 11
11
USP Sodium Bromide RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun, Pharm.D.
Associate Scientific Liaison (301) 230-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 4931
Pharmacopeial Forum: Volume No. 40(6)