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.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.0 and 7.0.
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— 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