Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension

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 and Hydrocortisone Ophthalmic Suspension is a sterile, aqueous suspension 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 contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone.

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 (11)-

USP Hydrocortisone RS

USP Neomycin Sulfate RS

USP Polymyxin B. Sulfate RS

THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): meets the requirements.

STERILITY TESTS (71): meets the requirements.

PH (791): between 4.1 and 7.0.

Assay for neomycin-Proceed as directed for neomycin under Antibiotics-Microbial Assays (81), using an accurately measured volume of Ophthalmic Suspension, freshly mixed and free from air bubbles, diluted quantitatively and stepwise withBuffer B.3to yield a Test 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 B under Antibiotics-Microbial Assays (81), using an accurately measured volume of Ophthalmic Suspension, freshly mixed and free from air bubbles, diluted quantitatively and stepwise with Buffer B.6 to yield a Test 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 Neomycin Sulfate RS, dissolved in Buffer B.6, to yield the same concentration of neomycin as is present in the Test Dilution.

Assay for hydrocortisone

Mobile phase, Standard preparation, and Chromatographic system-Prepare as directed in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment.

Assay preparation-Transfer an accurately measured volume of Ophthalmic Suspension, freshly mixed and free from air bubbles, equivalent to about 30 mg of hydrocortisone, to a 200-mL volumetric flask, dilute with a mixture of methanol and water (1:1) to volume, and mix. Filter the solution, rejecting the first 10 mL of the filtrate.

Procedure-Proceed as directed for Procedure in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment. Calculate the quantity, in mg, of C₂₁H₃₀O₅ in each mL of the Ophthalmic Suspension taken by the formula:

200(C/V)(r_u /r_s )

in which C is the concentration, in mg per mL, of USP Hydrocortisone RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Suspension taken, and r_u and r_s are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.