Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment
»Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate,Polymyxin B Sulfate,and Bacitracin.It contains the equivalent of not less than 90.0percent and not more than 140.0percent of the labeled amounts of neomycin,polymyxin B,and bacitracin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration underTest for Sterility of the Product to be Examined.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 0.5%,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 forMetal Particles in Ophthalmic Ointments á751ñ.
Assay for neomycin and Assay for polymyxin B— Proceed with Ophthalmic Ointment as directed in theAssay for neomycin and in theAssay for polymyxin BunderNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for bacitracin— Proceed with Ophthalmic Ointment as directed in theAssay for bacitracin underBacitracin Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1353
Pharmacopeial Forum:Volume No.28(4)Page 1160
Phone Number:1-301-816-8335