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.
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.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2491