Dihydrostreptomycin Sulfate Boluses

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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). 

1 Packaging and storage—

Preserve in tight containers. 

2 Labeling—

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

2.1 USP Reference standards 〈11〉— 

USP Dihydrostreptomycin Sulfate RS 

2.2 Loss on drying 〈731〉—

Dry about 100 mg, accurately weighed, of nely 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. 

3 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 B.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 B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.