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.
USP Reference standards 11
USP Gentamicin Sulfate RS Click to View Structure
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.
Other requirements— It meets the requirements of the test for Water and of the Assay in Gentamicin Sulfate Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3327