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.
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
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