Dihydrostreptomycin Injection

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 Injection contains an amount of Dihydrostreptomycin Sulfate equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of dihydrostreptomycin (C₂₁H₄₁N₇O₁₂). It contains one or more suitable preservatives. 

1 Packaging and storage—

Preserve in single-dose or multiple-dose containers. 

2 Labeling—

Label it to indicate that it is intended for veterinary use only. 

USP Reference standards 〈11〉— 

USP Dihydrostreptomycin Sulfate RS 

3 Identication—

It responds to the Identication tests under Dihydrostreptomycin Sulfate. 

Bacterial Endotoxins Test 〈85〉 —It contains not more than 0.5 USP Endotoxin Unit per mg of dihydrostreptomycin. 

Sterility Tests 〈71〉 —It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined. 

pH 〈791〉: between 5.0 and 8.0.

4 Assay— 

Assay preparation 1 (where it is represented as being in a single-dose container)—Withdraw all of the withdrawable contents of Injection, using a suitable hypodermic needle and syringe, and dilute quantitatively with water to obtain a solution containing a convenient quantity of dihydrostreptomycin in each mL. 

Assay preparation 2 (where the label states the quantity of dihydrostreptomycin in a given volume of solution)—Dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing a convenient quantity of dihydrostreptomycin in each mL. Procedure—Proceed as directed for the turbidimetric assay of dihydrostreptomycin under Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of Assay preparation diluted quantitatively with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.