» Nystatin Cream contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of USP Nystatin Units.
Packaging and storage Preserve in collapsible tubes, or in other tight containers, and avoid exposure to excessive heat.
USP Reference standards 11
Minimum fill 755: meets the requirements.
Assay Proceed as directed for Nystatin under AntibioticsMicrobial Assays 81, blending a suitable accurately weighed portion of Cream in a high-speed blender for 3 to 5 minutes with a sufficient accurately measured volume of dimethylformamide to give a concentration of about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 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.
USP35NF30 Page 4091Pharmacopeial Forum: Volume No. 28(1) Page 134