Neomycin Sulfate and Flurandrenolide Cream
» Neomycin Sulfate and Flurandrenolide 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 not less than 90.0 percent and not more than 110.0 percent of the labeled amount of flurandrenolide (C24H33FO6).
Packaging and storage— Preserve in collapsible tubes or in tight containers, protected from light.
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 Flurandrenolide Cream.
Minimum fill 755: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in the Assay under Neomycin Sulfate Ointment.
Assay for flurandrenolide— Proceed with Cream as directed in the Assay under Flurandrenolide Cream. Calculate the quantity, in mg, of C24H33FO6 in the portion of Cream taken by the formula:
10C(rU / rS)
in which C is the concentration, in mg per mL, of USP Flurandrenolide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 3050
Pharmacopeial Forum: Volume No. 28(4) Page 1155
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.