» 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.
Packaging and storage Preserve in single-dose or multiple-dose containers.
Labeling Label it to indicate that it is intended for veterinary use only.
Identification It responds to the Identification tests under Dihydrostreptomycin Sulfate.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mg of dihydrostreptomycin.
Sterility 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.
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 AntibioticsMicrobial 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.
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USP32NF27 Page 2153