U.S. PHARMACOPEIA

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Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment
» Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin, polymyxin B, and bacitracin. It may contain a suitable local anesthetic.
Packaging and storage— Preserve in well-closed containers, preferably at controlled room temperature.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin, Assay for polymyxin B, and Assay for bacitracin— Proceed with Ointment as directed in the Assay for neomycin, in the Assay for polymyxin B, and in the Assay for bacitracin under Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1504
Pharmacopeial Forum : Volume No. 28(4) Page 1161
Phone Number : 1-301-816-8223