Gentamicin Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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.

1 Packaging and storage

Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference standards 〈11〉

USP Gentamicin Sulfate RS

2 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. [Note-Dilute 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 fllower 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 R values of the three principal spots obtained from the test solution correspond to those obtained from the

Standard solution.

Bacterial Endotoxins Test 〈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 in Injections 〈788〉: meets the requirements for small-volume injections.

3 Other requirements

It meets the requirements under Injections and Implanted Drug Products 〈1〉.

4 Assay

Proceed as directed under Antibiotics - Microbial Assays 〈81〉, using an accurately measured volume of Injection diluted quantitatively and stepwise with Buffer B.3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (0.1μg of gentamicin per mL).