A: Dilute a suitable volume of Injection with water to obtain a test solution having a concentration of about 1 mg of kanamycin per mL. This solution meets the requirements of Identification test A under Kanamycin Sulfate Capsules.

B: The retention time of the peak for kanamycin in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Kanamycin Sulfate.

Assay preparation— Dilute an accurately measured volume of Injection quantitatively, and stepwise if necessary, with water to obtain a solution having a concentration of about 0.006 mg of kanamycin per mL.

Procedure— Proceed as directed in the Assay under Kanamycin Sulfate. Calculate the quantity, in mg, of kanamycin (C18H36N4O11) in each mL of the Injection taken by the formula: in which L is the labeled quantity, in mg, of kanamycin in each mL of the Injection; D is the concentration, in mg per mL, of kanamycin in the Assay preparation, on the basis of the labeled quantity per mL and the extent of dilution; and the other terms are as defined therein.