Dihydrostreptomycin Sulfate Boluses
» Dihydrostreptomycin Sulfate Boluses contain the equivalent of not less than 85.0 percent and not more than 120.0 percent of the labeled amount of dihydrostreptomycin (C21H41N7O12).
Packaging and storage— Preserve in tight containers.
Labeling— Label Boluses to indicate that they are intended for veterinary use only.
Loss on drying 731 Dry about 100 mg, accurately weighed, of finely ground Boluses in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 10.0% of its weight.
Assay— Proceed as directed for the cylinder-plate assay of dihydrostreptomycin under AntibioticsMicrobial Assays 81, using 3 Boluses added to a mixture of 499.0 mL of Buffer No. 3 and 1.0 mL of polysorbate 80 and blended for 5 minutes in a high-speed glass blender jar. Allow to stand for not less than 1 hour, and repeat the blending. While stirring this mixture, withdraw an accurately measured volume of it, and dilute quantitatively and stepwise with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2153