Neomycin and Polymyxin B Sulfates Ophthalmic Ointment
» Neomycin and Polymyxin B Sulfates Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate and Polymyxin B Sulfate. It 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.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3056
Pharmacopeial Forum: Volume No. 28(4) Page 1159