Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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 90.0 percent and not more than 130.0 percent 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 (11)-
USP Gramicidin RS
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 4.7 and 6.0.
Assay for neomycin-Proceed as directed for neomycin under Antibiotics-Microbial Assays (81), using an accurately measured volume of Ophthalmic Solution 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 Solution diluted quantitatively and stepwise withBuffer B.6to 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 USP Neomycin Sulfate RS, dissolved in Buffer B.6, to obtain the same concentration of neomycin as is present in the Test Dilution.
Assay for gramicidin-Proceed as directed for gramicidin under Antibiotics-Microbial Assays (81), using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with alcohol to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
