U.S. PHARMACOPEIA

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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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin— Proceed with Ointment as directed in the Assay under Neomycin Sulfate Ointment.
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— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1497
Pharmacopeial Forum : Volume No. 28(4) Page 1157
Phone Number : 1-301-816-8223