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

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution

»Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is a sterile,isotonic aqueous solution of Neomycin Sulfate,Polymyxin B Sulfate,and Gramicidin.It contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin,polymyxin B,and gramicidin.

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.

USP Reference standards á11ñ— USP Gramicidin RS.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 4.7and 6.0.

Assay for neomycin— Proceed as directed for neomycin underAntibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise withBuffer No.3to yield aTest Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Assay for polymyxin B— Proceed as directed for polymyxin BunderAntibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise withBuffer No.6to yield aTest Dilution having a concentration assumed to be equal to the median dose level of the Standard.Add to each test dilution of the Standard a quantity of USP Neomycin Sulfate RS,dissolved inBuffer No.6,to obtain the same concentration of neomycin as is present in theTest Dilution.

Assay for gramicidin— Proceed as directed for gramicidin underAntibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with alcohol to yield aTest Dilution having a concentration assumed to be equal to the median dose level of the Standard.

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

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1357

Pharmacopeial Forum:Volume No.28(4)Page 1163

Phone Number:1-301-816-8335