U.S. PHARMACOPEIA

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Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Cream
» Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Cream contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin and polymyxin B, 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 well-closed containers.
Identification—
A: It meets the requirements 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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin and Assay for polymyxin B— Proceed with Cream as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates Cream.
Assay for hydrocortisone acetate— Proceed with Cream as directed in the Assay under Hydrocortisone Acetate Lotion.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1510
Pharmacopeial Forum : Volume No. 30(2) Page 520
Phone Number : 1-301-816-8223