Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Ophthalmic Suspension
»Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Ophthalmic Suspension is a sterile suspension of Hydrocortisone Acetate in an aqueous solution of Neomycin Sulfate and Polymyxin B Sulfate.It contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amounts of neomycin and polymyxin B,and not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone acetate (C23H32O6).It may contain suitable buffers,preservatives,and suspending agents.
Packaging and storage— Preserve in tight containers.The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration underTest for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.0.
Assay for neomycin and Assay for polymyxin B— Proceed with Ophthalmic Suspension as directed in the Assay for neomycinand in the Assay for polymyxin Bunder Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for hydrocortisone acetate— Proceed with Ophthalmic Suspension as directed in the Assayunder Hydrocortisone Acetate Injectable Suspension.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1359
Phone Number:1-301-816-8335