Neomycin Sulfate and Hydrocortisone Acetate Cream
» Neomycin Sulfate and Hydrocortisone Acetate Cream contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone acetate (C23H32O6).
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11
USP Hydrocortisone Acetate RS Click to View Structure
USP Neomycin Sulfate RS
Identification—
A: It meets the requirements for neomycin 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.
Assay for neomycin— Proceed with Cream as directed in the Assay under Neomycin Sulfate Ointment.
Assay for hydrocortisone acetate— Proceed with Cream 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 4016
Pharmacopeial Forum: Volume No. 30(2) Page 517