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.
Minimum fill 755: meets the requirements.
Assay— Proceed as directed under Antibiotics—Microbial 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3046
Pharmacopeial Forum: Volume No. 28(4) Page 1152