Neomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Acetate Ophthalmic Ointment
»Neomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Acetate Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate,Polymyxin B Sulfate,Bacitracin Zinc,and Hydrocortisone Acetate.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,and not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone acetate.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification—
A: It meets the requirements underThin-Layer Chromatographic Identification Test á201BNPñ.
B: The retention time of the major peak for hydrocortisone acetate in the chromatogram of theAssay preparationcorresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay for hydrocortisone acetate.
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,Assay for polymyxin B,and Assay for bacitracin— Proceed with Ophthalmic Ointment as directed in theAssay for neomycin,in theAssay for polymyxin B,and in theAssay for bacitracin underNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for hydrocortisone acetate— Proceed with Ophthalmic Ointment as directed in theAssay underHydrocortisone Acetate Lotion.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1355
Pharmacopeial Forum:Volume No.30(2)Page 519
Phone Number:1-301-816-8335