Neomycin Sulfate Ophthalmic Ointment
» Neomycin Sulfate Ophthalmic Ointment is a sterile preparation of Neomycin Sulfate in a suitable ointment base. It contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Sterility 71: meets the requirements.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 1.0%, 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— Proceed with Ophthalmic Ointment as directed in the Assay under Neomycin Sulfate 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 3047
Pharmacopeial Forum: Volume No. 28(4) Page 1153