Neomycin and Polymyxin B Sulfates,Bacitracin,and Hydrocortisone Acetate Ophthalmic Ointment
»Neomycin and Polymyxin B Sulfates,Bacitracin,and Hydrocortisone Acetate Ophthalmic Ointment 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,in a suitable ointment base.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification—
A: It meets the requirements under Thin-Layer Chromatographic Identification Test á201BNPñ.
B: The retention time of the major peak for hydrocortisone acetate in the chromatogram of the Assay 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 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 underBacitracin 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 1353
Pharmacopeial Forum:Volume No.30(2)Page 519
Phone Number:1-301-816-8335