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

Neomycin and Polymyxin B Sulfates Solution for Irrigation

»Neomycin and Polymyxin B Sulfates Solution for Irrigation is a sterile,aqueous solution containing the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin and of polymyxin B.It may contain a suitable preservative.

Packaging and storage— Preserve in tight containers.

Labeling— Label it to indicate that it is to be diluted for use in a urinary bladder irrigation and is not intended for injection.

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 4.5and 6.0.

Assay for neomycin and Assay for polymyxin B— Proceed with Neomycin and Polymyxin B Sulfates Solution for Irrigation 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