Dihydrostreptomycin Injection
»Dihydrostreptomycin Injection contains an amount of Dihydrostreptomycin Sulfate equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of dihydrostreptomycin (C21H41N7O12).It contains one or more suitable preservatives.
Packaging and storage— Preserve in single-dose or in multiple-dose containers.
Labeling— Label it to indicate that it is intended for veterinary use only.
Identification— It responds to the Identificationtests under Dihydrostreptomycin Sulfate.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mg of dihydrostreptomycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 8.0.
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 á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 650
Phone Number:1-301-816-8178