Neomycin Sulfate Ointment
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Neomycin Sulfate Ointment contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin.
Packaging and storage-Preserve in well-closed containers, preferably at controlled room temperature.
USP REFERENCE STANDARDS (11)
USP Neomycin Sulfate RS
THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): meets the requirements.
MINIMUM FILL (755): meets the requirements.
WATER DETERMINATION, Method / (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-Proceed as directed under Antibiotics-Microbial Assays (81), using an accurately weighed portion of Ointment, equivalent to about 3.5 mg of neomycin, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of Buffer B.3. Combine the aqueous extracts, and dilute with Buffer B.3 to an appropriate volume to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
