Gentamicin Sulfate Ophthalmic Ointment
»Gentamicin Sulfate Ophthalmic Ointment 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 collapsible ophthalmic ointment tubes,and avoid exposure to excessive heat.
Identification— Shake a quantity of Ophthalmic Ointment,equivalent to about 5mg of gentamicin,with a mixture of 200mLof chloroform and 5mLof water.Allow to separate,and filter the aqueous layer:the filtrate so obtained meets the requirements of the Identificationtest under Gentamicin Injection.
Sterility á71ñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.
Other requirements— It meets the requirements of the test for Waterand of the Assayin Gentamicin Sulfate Ointment.
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