Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ointment
» Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 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, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone.
Packaging and storage— Preserve in well-closed containers, preferably at controlled room temperature.
USP Reference standards 11—
USP Bacitracin Zinc RS
USP Hydrocortisone RS Click to View Structure
USP Neomycin Sulfate RS
USP Polymyxin B Sulfate RS
Identification—
A: It meets the requirements under Thin-Layer Chromatographic Identification Test 201BNP.
B: The retention time of the major peak for hydrocortisone in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for hydrocortisone.
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, 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.
Assay for hydrocortisone— Proceed with the Ointment as directed in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic 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 4023
Pharmacopeial Forum: Volume No. 28(4) Page 1162