U.S. PHARMACOPEIA

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Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment
» Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate, Polymyxin B Sulfate, and Bacitracin. It contains the equivalent of not less than 90.0 percent and not more than 140.0 percent of the labeled amounts of neomycin, polymyxin B, and bacitracin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
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.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin and Assay for polymyxin B— Proceed with Ophthalmic Ointment as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for bacitracin— Proceed with Ophthalmic Ointment as directed in the Assay for bacitracin under Bacitracin Ointment.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1503
Pharmacopeial Forum : Volume No. 28(4) Page 1160
Phone Number : 1-301-816-8223