» Gentamicin Injection contains an amount of Gentamicin Sulfate equivalent to not less than 90.0 percent and not more than 125.0 percent of the labeled amount of gentamicin. It may contain suitable buffers, preservatives, and sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Identification Apply separately a volume of Injection equivalent to 20 µg of gentamicin and the same volume of a similar preparation of USP Gentamicin Sulfate RS to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel having an average pore size of 6 nm. [noteDilute the Injection with water, if necessary, to obtain a test solution containing 1000 µg of gentamicin per mL. Where the Injection contains less than 1000 µg per mL, apply a volume of it, equivalent to 20 µg of gentamicin, to the chromatographic plate, in separate portions of not more than 20 µL each, each application being allowed to dry before the next is applied.] Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of the lower phase of a mixture of chloroform, methanol, and ammonium hydroxide (20:13:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and expose the plate to vapors of iodine in a detection jar containing iodine crystals: the intensities and RF values of the three principal spots obtained from the test solution correspond to those obtained from the Standard solution.
Bacterial endotoxins 85 It contains not more than 0.71 USP Endotoxin Unit per mg of gentamicin.
pH 791: between 3.0 and 5.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Assay Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately measured volume of Injection diluted quantitatively and stepwise with Buffer No. 3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (0.1 µg of gentamicin per mL).
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USP32NF27 Page 2490