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Neomycin Sulfate and Hydrocortisone Ointment
»Neomycin Sulfate and Hydrocortisone Ointment contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin,and not less than 90.0percent and not more than 110.0percent 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 underThin-Layer Chromatographic Identification Test á201BNPñ.
B:
The retention time of the major peak for hydrocortisone acetate in the chromatogram of theAssay preparationcorresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay for hydrocortisone.
Minimum fill á755ñ:
meets the requirements.
Water,Method Iá921ñ:
not more than 1.0%,20mLof 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 theAssay for hydrocortisone underNeomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Ophthalmic Ointment.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1348
Pharmacopeial Forum:Volume No.28(4)Page 1157
Phone Number:1-301-816-8335
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