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.
USP Reference standards 11—
USP Bacitracin Zinc RS
USP Neomycin Sulfate RS
USP Polymyxin B Sulfate RS
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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161		 (SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339		 (GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4021
Pharmacopeial Forum: Volume No. 28(4) Page 1160