Neomycin Sulfate Ophthalmic Ointment
»Neomycin Sulfate Ophthalmic Ointment is a sterile preparation of Neomycin Sulfate in a suitable ointment base.It contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Sterility á71ñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 1.0%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.
Assay— Proceed with Ophthalmic Ointment as directed in the Assayunder Neomycin Sulfate Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1343
Pharmacopeial Forum:Volume No.28(4)Page 1153
Phone Number:1-301-816-8335