U.S. PHARMACOPEIA

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Gentamicin Sulfate Ophthalmic Ointment
» Gentamicin Sulfate Ophthalmic Ointment contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of gentamicin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes, and avoid exposure to excessive heat.
Identification— Shake a quantity of Ophthalmic Ointment, equivalent to about 5 mg of gentamicin, with a mixture of 200 mL of chloroform and 5 mL of water. Allow to separate, and filter the aqueous layer: the filtrate so obtained meets the requirements of the Identification test under Gentamicin Injection.
Sterility 71: meets the requirements.
Minimum fill 755: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements of the test for Water and of the Assay in Gentamicin Sulfate Ointment.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 995
Phone Number : 1-301-816-8223