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 90.0percent and not more than 135.0percent of the labeled amount of gentamicin.
Packaging and storage— Preserve in tight containers,and avoid exposure to excessive heat.
pHá791ñ: between 6.5and 7.5.
Other requirements— It meets the requirements of the Identificationtest under Gentamicin Injectionand meets the requirements under Sterility Tests á71ñ,when tested as directed in the section Membrane Filtrationin Test for Sterility of the Product To Be Examined.
Assay— Proceed with Ophthalmic Solution as directed in the Assayunder Gentamicin Injection.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 897
Phone Number:1-301-816-8335