» Tobramycin Injection is a sterile solution of Tobramycin Sulfate in Water for Injection, or of Tobramycin in Water for Injection prepared with the aid of Sulfuric Acid. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of tobramycin (C18H37N5O9).
Packaging and storage Preserve in single-dose or multiple-dose glass or plastic containers. Glass containers are preferably of Type I glass.
A: Dilute the Injection with water to obtain a solution containing 6 mg of tobramycin per mL, and proceed as directed for Identification test A under Tobramycin, beginning with Apply 3 µL of this test solution.
B: The retention time of the major peak for tobramycin in the chromatogram of the Derivatized assay preparation corresponds to that in the chromatogram of the Derivatized standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 2.00 USP Endotoxin Units per mg of tobramycin.
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 3.0 and 6.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Mobile phase, 2,4-Dinitrofluorobenzene reagent, Tris(hydroxymethyl)aminomethane reagent, Standard preparation, Derivatization procedure, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Tobramycin.
Assay preparation Dilute an accurately measured volume of Injection quantitatively, and stepwise if necessary, with water to obtain a solution containing the equivalent of about 0.2 mg of tobramycin per mL.
Procedure Proceed as directed in the Assay under Tobramycin. Calculate the quantity, in mg, of tobramycin (C18H37N5O9) in each mL of the Injection taken by the formula:
(L / D)(CE / 1000)(rU / rS)in which L is the labeled quantity, in mg per mL, of tobramycin (C18H37N5O9) in the Injection; D is the concentration, in mg per mL, of tobramycin in the Assay preparation, on the basis of the labeled quantity, the volume taken, and the extent of dilution; and the other terms are as defined therein.
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USP32NF27 Page 3757