Gentamicin Sulfate Ophthalmic Solution
» Gentamicin Sulfate Ophthalmic Solution is a sterile, buffered solution of Gentamicin Sulfate with preservatives. It 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 tight containers, and avoid exposure to excessive heat.
USP Reference standards 11
USP Gentamicin Sulfate RS Click to View Structure
pH 791: between 6.5 and 7.5.
Other requirements— It meets the requirements of the Identification test under Gentamicin Injection and meets the requirements under Sterility Tests 71, when tested as directed in the section Membrane Filtration in Test for Sterility of the Product To Be Examined.
Assay— Proceed with Ophthalmic Solution as directed in the Assay under Gentamicin Injection.
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
USP35–NF30 Page 3327