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.
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.
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.
Chromatographic Column
USP32NF27 Page 3053
Pharmacopeial Forum: Volume No. 30(2) Page 518
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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