Neomycin Sulfate and Hydrocortisone Ointment
» Neomycin Sulfate and Hydrocortisone 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 (C21H30O5).
Packaging and storage
Preserve in collapsible tubes or in well-closed containers.
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.
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 hydrocortisone
Proceed with 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.
Chromatographic Column
USP32NF27 Page 3051
Pharmacopeial Forum: Volume No. 28(4) Page 1157
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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