Neomycin and Polymyxin B Sulfates Ophthalmic Solution

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

1 Packaging and storage

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

1.1 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 5.0 and 7.0.

2 Assay for neomycin and Assay for polymyxin B

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