Neomycin Sulfate Cream
» Neomycin Sulfate Cream 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.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Minimum fill 755: meets the requirements.
Assay Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately weighed portion of Cream, equivalent to about 1.75 mg of neomycin, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of Buffer No. 3. Combine the aqueous extracts, and dilute with Buffer No. 3 to an appropriate volume to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 3046Pharmacopeial Forum: Volume No. 28(4) Page 1152