Add the following:
Potassium Bromide Oral Solution, Veterinary
» Potassium Bromide Oral Solution, Veterinary contains an amount of Potassium Bromide equivalent to not less than 151 mg and not more than 185 mg of bromide (Br ) per mL (see Pharmaceutical CompoundingNonsterile Preparations 795):
Dissolve an accurately weighed quantity of Potassium Bromide in water. Add Corn Syrup to volume with mixing.
Packaging and storage Package in a tight container, and store in a refrigerator.
Labeling Label it to indicate that it is to be discarded after 180 days, to state that it is to be kept out of the reach of children, to indicate the nominal content of potassium bromide in the Oral Solution, Veterinary and to state that it is for veterinary use only.
Beyond-use date: 180 days after the date on which it was compounded.
TCA solution Dissolve a quantity of trichloroacetic acid in water to obtain a 20% (w/v) solution.
Gold chloride solution Dissolve a quantity of gold chloride in water to obtain a 0.5% (w/v) solution.
Blank Use water.
Bromide standard stock solution Dissolve an accurately weighed quantity of USP Sodium Bromide RS in water to obtain a solution having a known concentration equivalent to about 20 mg of bromide per mL.
Standard preparations Prepare four Standard preparation solutions of known concentrations of about 2.0 mg of bromide per mL, 1.0 mg of bromide per mL, 0.5 mg of bromide per mL, and 0.25 mg of bromide per mL by quantitatively diluting the Bromide standard stock solution with the appropriate volumes of water.
Assay preparation Dilute Oral Solution, Veterinary quantitatively with water (1:99).
Procedure (see Spectrophotometry and Light Scattering 851) To 750-µL aliquots each of Blank, the four Standard preparations, and the Assay preparation add 500 µL of TCA solution and 250 µL of Gold chloride solution. Mix on a vortex mixer, and immediately read the absorbance at 440 nm. Generate a standard curve of absorbance versus bromide concentration, correcting for the blank, and calculate the regression line and the regression coefficient. The test is considered valid if the square of the correlation coefficient of the regression curve (r2) is not less than 0.99. Calculate the concentration, in mg per mL, of bromide (Br ) in the portion of Oral Solution, Veterinary taken by the formula:
100Cin which C is the concentration, in mg per mL, of bromide in the Assay preparation as calculated from the regression line.USP32
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USP32NF27 Page 3335Pharmacopeial Forum: Volume No. 33(5) Page 936