A: Dilute it with water to obtain a solution containing 6 mg per mL: the resulting solution meets the requirements of Identification test A under Amikacin.

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

(Official January 1, 2007)

Mobile phase, System suitability solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Amikacin.

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 0.02 mg of amikacin (C22H43N5O13) per mL.

Procedure— Proceed as directed in the Assay for Amikacin. Calculate the quantity, in mg, of amikacin (C22H43N5O13) in each mL of the Injection taken by the formula: in which L is the labeled quantity, in mg, of amikacin in each mL of Injection; D is the concentration, in mg per mL, of amikacin (C22H43N5O13) 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.