Neomycin Sulfate and Flurandrenolide Ointment
» Neomycin Sulfate and Flurandrenolide 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 flurandrenolide (C24H33FO6).
Packaging and storage Preserve in collapsible tubes or in tight containers, protected from light.
USP Reference standards 11
USP Neomycin Sulfate RS
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.
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.
Assay for neomycin Proceed with Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Assay for flurandrenolide Proceed with Ointment as directed in the Assay under Flurandrenolide Cream. Calculate the quantity, in mg, of C24H33FO6 in the portion of Ointment 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.
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USP35NF30 Page 4015Pharmacopeial Forum: Volume No. 28(4) Page 1156