Neomycin and Polymyxin B Sulfates and Bacitracin Ointment
» Neomycin and Polymyxin B Sulfates 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, polymyxin B, and bacitracin. It may contain a suitable local anesthetic.
Packaging and storage— Preserve in tight, light-resistant containers, preferably at controlled room temperature.
USP Reference standards 11
USP Bacitracin Zinc RS
USP Neomycin Sulfate RS
USP Polymyxin B Sulfate RS
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.
Assay for neomycin and Assay for polymyxin B— Proceed with Ointment 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 bacitracin— Proceed with Ointment as directed in the Assay under Bacitracin Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 4021
Pharmacopeial Forum: Volume No. 28(4) Page 1160