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 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.

Residual solvents 467: meets the requirements.

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 with Buffer No. 3 to 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 with Buffer No. 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 USP Neomycin Sulfate RS, dissolved in Buffer No. 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.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1508

Phone Number : 1-301-816-8223