U.S. PHARMACOPEIA

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Neomycin Sulfate and Fluocinolone Acetonide Cream
» Neomycin Sulfate and Fluocinolone Acetonide Cream contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of fluocinolone acetonide (C24H30F2O6).
Packaging and storage— Preserve in collapsible tubes or in tight containers.
Identification—
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test 201BNP.
B: It meets the requirements for the Identification test under Fluocinolone Acetonide Cream.
Minimum fill 755: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin— Proceed with Cream as directed in the Assay under Neomycin Sulfate Cream.
Assay for fluocinolone acetonide— Proceed with Cream as directed in the Assay under Fluocinolone Acetonide Cream.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1495
Pharmacopeial Forum : Volume No. 28(4) Page 1155
Phone Number : 1-301-816-8223