Neomycin and Polymyxin B Sulfates Ophthalmic Solution, chemical structure, molecular formula, Reference Standards

Neomycin and Polymyxin B Sulfates Ophthalmic Solution

»Neomycin and Polymyxin B Sulfates Ophthalmic Solution contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin and polymyxin B.It may contain one or more suitable buffers,dispersants,irrigants,and preservatives.

Packaging and storage— Preserve in tight containers,and avoid exposure to excessive heat.

USP Reference standards á11ñ— USP Neomycin Sulfate RS.USP Polymyxin B Sulfate RS.

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.

pHá791ñ: between 5.0and 7.0.

Assay for neomycin and Assay for polymyxin B— Proceed with Ophthalmic Solution as directed in theAssay for neomycin and in theAssay for polymyxin BunderNeomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1352

Pharmacopeial Forum:Volume No.28(4)Page 1159

Phone Number:1-301-816-8335