Packaging and storage— Preserve in tight containers.

Labeling— Label Boluses to indicate that they are intended for veterinary use only.

USP Reference standards 11— USP Dihydrostreptomycin Sulfate RS.

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.

Residual solvents 467: meet the requirements.

Assay— Proceed as directed for the cylinder-plate assay of dihydrostreptomycin under Antibiotics—Microbial 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.

Expert Committee : (VET05) Veterinary Drugs 05

USP29–NF24 Page 708

Phone Number : 1-301-816-8178