USP Monographs: Neomycin and Polymyxin B Sulfates Ophthalmic Solution

Neomycin and Polymyxin B Sulfates Ophthalmic Solution

» 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.

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

USP Reference standards

— USP Neomycin Sulfate RS. USP Polymyxin B Sulfate RS.

Thin-layer chromatographic identification test

201BNP

: meets the requirements.

Sterility

— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

791

: between 5.0 and 7.0.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

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.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1502

Pharmacopeial Forum : Volume No. 28(4) Page 1159

Phone Number : 1-301-816-8223


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