Packaging and storage— Preserve in collapsible tubes, or in other tight containers, and avoid exposure to excessive heat.

USP Reference standards 11— USP Nystatin RS.

Minimum fill 755: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Proceed as directed for Nystatin under Antibiotics—Microbial 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.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1567

Phone Number : 1-301-816-8223