» Kanamycin Injection contains an amount of Kanamycin Sulfate equivalent to not less than 90.0 percent and not more than 115.0 percent 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 I or Type III glass.
USP Reference standards 11
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 0.67 USP Endotoxin Unit per mg of kanamycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.5 and 5.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
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:
(L / D)(CP / 1000)(rU / rS)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.
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USP35NF30 Page 3617Pharmacopeial Forum: Volume No. 26(6) Page 1554