Neomycin Sulfate and Flurandrenolide Ointment

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

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).

1 Packaging and storage

Preserve in collapsible tubes or in tight containers, protected from light.

1.1 USP Reference standards 〈11〉

USP Flurandrenolide RS

USP Neomycin Sulfate RS

2 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.

Water Determination, 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.

3 Assay for neomycin

Proceed with Ointment as directed in the Assay under Neomycin Sulfate Ointment.

4 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.