Amikacin Sulfate Injection
» Amikacin Sulfate Injection is a sterile solution of Amikacin Sulfate in Water for Injection, or of Amikacin 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 amikacin (C22H43N5O13).
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type III glass.
USP Reference standards 11
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 0.33 USP Endotoxin Unit per mg of amikacin.
pH 791: between 3.5 and 5.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
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:
(L / D)(CE / 1000)(rU / rS)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.
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USP35NF30 Page 2160Pharmacopeial Forum: Volume No. 37(4)