Neomycin and Polymyxin B Sulfates, Bacitracin, and Hydrocortisone Acetate Ointment
» Neomycin and Polymyxin B Sulfates, Bacitracin, and Hydrocortisone Acetate 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 acetate in a suitable ointment base.
Packaging and storage— Preserve in collapsible tubes or in well-closed containers.
USP Reference standards 11
USP Bacitracin Zinc RS
USP Hydrocortisone Acetate 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 acetate in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for hydrocortisone acetate.
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.
Assay for hydrocortisone acetate— Proceed with Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.
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. 30(2) Page 519