Identification—
A:
It responds to the Identificationtests under Tobramycin.
B:
It responds to the tests for Sulfate á191ñ.
Sterility á71ñ—
It meets the requirements when tested as directed for
Membrane Filtrationunder
Test for Sterility of the Product to be Examined,6g being used if it is not packaged for dispensing.
pHá791ñ:
between 6.0and 8.0,in a solution containing 40mg per mL(or,where packaged for dispensing,in the solution constituted as directed in the labeling).
Assay—
Mobile phase,2,4-Dinitrofluorobenzene reagent,Tris(hydroxymethyl)aminomethane reagent,Standard preparation,Derivatization procedure,Resolution solution,and Chromatographic system—
Proceed as directed in the Assayunder Tobramycin.
Assay preparation 1
(where it is represented as being in a single-dose container)—Constitute a container of Tobramycin for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with water to obtain a solution containing the equivalent of about 0.2mg of tobramycin (C18H37N5O9)per mL.
Assay preparation 2
(where the label states the quantity of tobramycin in a given volume of constituted solution)—Constitute a container of Tobramycin for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing about 0.2mg of tobramycin (C18H37N5O9)per mL.
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Tobramycin.Calculate the quantity,in mg,of tobramycin (C
18H
37N
5O
9)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CE/1000)(rU/rS),
in which
Lis the labeled quantity,in mg,of tobramycin (C
18H
37N
5O
9)in the container,or in the volume of constituted solution taken;
Dis the concentration,in mg of tobramycin per mL,of
Assay preparation 1or
Assay preparation 2,based on the labeled quantity in the container or in the volume of constituted solution taken,respectively,and the extent of dilution;and the other terms are as defined therein.