Printed on: Tue Mar 19 2024, 02:33:54 AM(EST) Status: Currently Official on 19-Mar-2024 DocId: GUID-B7C49759-B06A-45C0-8C83-942DC936EA0D_3_en-US
Printed by: USMAN SHAHZAD Official Date: Official as of 01-May-2018 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: 5qs4q DOI: [Link]
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plate, in separate portions of not more than 20 µL each, each
Gentamicin Injection application being allowed to dry before the next is applied.]
Place the plate in a suitable chromatographic chamber, and
» Gentamicin Injection contains an amount of develop the chromatogram in a solvent system consisting of
the lower phase of a mixture of chloroform, methanol, and
Gentamicin Sulfate equivalent to not less than 90.0 ammonium hydroxide (20:13:10) until the solvent front has
percent and not more than 125.0 percent of the moved about three-fourths of the length of the plate. Remove
labeled amount of gentamicin. It may contain the plate from the chamber, air-dry, and expose the plate to
suitable buffers, preservatives, and sequestering vapors of iodine in a detection jar containing iodine crystals:
agents, unless it is intended for intrathecal use, in the intensities and R F values of the three principal spots
obtained from the test solution correspond to those obtained
which case it contains only suitable tonicity agents. from the Standard solution.
Bacterial Endotoxins Test á85ñ —It contains not more than
Packaging and storage—Preserve in single-dose or 0.71 USP Endotoxin Unit per mg of gentamicin.
multiple-dose containers, preferably of Type I glass.
pH á791ñ: between 3.0 and 5.5.
USP Reference standards á11ñ—
Particulate Matter in Injections á788ñ: meets the
USP Gentamicin Sulfate RS
requirements for small-volume injections.
Identification—Apply separately a volume of Injection
Other requirements—It meets the requirements under
equivalent to 20 µg of gentamicin and the same volume of a
Injections and Implanted Drug Products á1ñ.
similar preparation of USP Gentamicin Sulfate RS to a suitable
Assay—Proceed as directed under Antibiotics—Microbial
thin-layer chromatographic plate (see Chromatography á621ñ)
Assays á81ñ, using an accurately measured volume of Injection
coated with a 0.25-mm layer of chromatographic silica gel
diluted quantitatively and stepwise with Buffer B.3 to yield a
having an average pore size of 6 nm. [NOTE—Dilute the
al
Test Dilution having a concentration assumed to be equal to
Injection with water, if necessary, to obtain a test solution
the median dose level of the Standard (0.1 µg of gentamicin
containing 1000 µg of gentamicin per mL. Where the Injection
per mL).
contains less than 1000 µg per mL, apply a volume of it,
equivalent to 20 µg of gentamicin, to the chromatographic
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