Kanamycin Injection
»Kanamycin Injection contains an amount of Kanamycin Sulfate equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of kanamycin (C18H36N4O11).It contains suitable buffers and preservatives.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIIglass.
Identification—
A: Dilute a suitable volume of Injection with water to obtain a test solution having a concentration of about 1mg of kanamycin per mL.This solution meets the requirements of Identificationtest Aunder Kanamycin Sulfate Capsules.
B: The retention time of the peak for kanamycin 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 0.67USP Endotoxin Unit per mg of kanamycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 3.5and 5.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder 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 0.006mg of kanamycin per mL.
Procedure— Proceed as directed in the Assayunder Kanamycin Sulfate.Calculate the quantity,in mg,of kanamycin (C18H36N4O11)in each mLof the Injection taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of kanamycin in each mLof the Injection;Dis the concentration,in mg per mL,of kanamycin 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 1096
Pharmacopeial Forum:Volume No.26(6)Page 1554
Phone Number:1-301-816-8335