U.S. PHARMACOPEIA

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Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Ophthalmic Suspension
» Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Ophthalmic Suspension is a sterile suspension of Hydrocortisone Acetate in an aqueous solution of Neomycin Sulfate and Polymyxin B Sulfate. It contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amounts of neomycin and polymyxin B, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone acetate (C23H32O6). It may contain suitable buffers, preservatives, and suspending agents.
Packaging and storage— Preserve in tight containers. The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin and Assay for polymyxin B— Proceed with Ophthalmic Suspension 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 hydrocortisone acetate— Proceed with Ophthalmic Suspension as directed in the Assay under Hydrocortisone Acetate Injectable Suspension.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1510
Phone Number : 1-301-816-8223