Neomycin and Polymyxin B Sulfates Solution for Irrigation

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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

1 Packaging and storage

Preserve in tight containers.

2 Labeling

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

2.1 USP Reference standards 〈11〉

USP Neomycin Sulfate RS

USP Polymyxin B Sulfate RS

Thin-layer chromatographic identification test 〈201BNP〉: meets the requirements.

Sterility Tests 〈71〉 - It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

pH 〈791〉: between 4.5 and 6.0.

3 Assay for neomycin and Assay for polymyxin B

Proceed with Neomycin and Polymyxin B Sulfates Solution for Irrigation as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.