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Sodium Bromide Injection, Veterinary
» Sodium Bromide Injection, Veterinary contains an amount of Sodium Bromide equivalent to not less than 21.0 mg and not more than 25.6 mg of bromide (Br ) per mL (see Pharmaceutical CompoundingSterile Preparations 797):
Dissolve an accurately weighed quantity of Sodium Bromide in Sterile Water for Injection to volume with mixing. Sterilize by a suitable means such as sterile filtration or autoclaving.
Packaging and storage Preserve in single-dose containers, preferably of Type I glass, 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, and to indicate the nominal content of sodium bromide in the Injection. Label it to indicate that it is for infusion only at a rate not to exceed 150 mg of sodium bromide per kg body weight per hour. Label it to indicate that it is for veterinary use only.
Beyond-use date: 180 days after the date on which it was compounded.
Bacterial endotoxins 85 It contains not more than 0.03 USP Endotoxin Unit per mg of sodium bromide.
Sterility 71: meets the requirements.
Other requirements It meets the requirements under Injections 1.
Trichloroacetic acid (TCA) solution Dissolve a quantity of TCA 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, respectively, by diluting quantitatively the Bromide standard stock solution with the appropriate volumes of water.
Assay preparation Dilute Injection, Veterinary quantitatively with water (1:19).
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 Trichloroacetic acid (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 Injection, Veterinary taken by the formula:
20Cin 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 3567Pharmacopeial Forum: Volume No. 33(5) Page 949