Neomycin Sulfate and Hydrocortisone Acetate Ointment
» Neomycin Sulfate and Hydrocortisone Acetate Ointment 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 collapsible tubes or in well-closed containers.
USP Reference standards 11
USP Neomycin Sulfate RS
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.
Water, Method I 921: not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Assay for neomycin Proceed with the Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Assay for hydrocortisone acetate Proceed with the Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4017Pharmacopeial Forum: Volume No. 30(2) Page 518