U.S. PHARMACOPEIA

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Neomycin Sulfate and Bacitracin Ointment
» Neomycin Sulfate and Bacitracin Ointment contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin and bacitracin.
Packaging and storage— Preserve in tight, light-resistant 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— Proceed with Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Assay for bacitracin— Proceed with Ointment as directed in the Assay under Bacitracin Ointment
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1493
Pharmacopeial Forum : Volume No. 28(4) Page 1153
Phone Number : 1-301-816-8223