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 90.0percent and not more than 120.0percent of the labeled amount of amikacin (C22H43N5O13).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIIglass.
Identification—
A: Dilute it with water to obtain a solution containing 6mg per mL:the resulting solution meets the requirements of Identificationtest Aunder Amikacin.
B: The retention time of the peak for amikacin in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of amikacin.
pHá791ñ: between 3.5and 5.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,System suitability solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder 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 0.02mg of amikacin (C22H43N5O13)per mL.
Procedure— Proceed as directed in the Assayfor Amikacin.Calculate the quantity,in mg,of amikacin (C22H43N5O13)in each mLof the Injection taken by the formula:
(L/D)(CE/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of amikacin in each mLof Injection;Dis the concentration,in mg per mL,of amikacin (C22H43N5O13)in the Assay preparation,on the basis of the labeled quantity per mLand the extent of dilution;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 117
Phone Number:1-301-816-8335