Nystatin Cream
»Nystatin Cream contains not less than 90.0percent and not more than 130.0percent 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.
Minimum fill á755ñ: meets the requirements.
Assay— Proceed as directed for Nystatin under Antibiotics—Microbial Assays á81ñ,blending a suitable accurately weighed portion of Cream in a high-speed blender for 3to 5minutes with a sufficient accurately measured volume of dimethylformamide to give a concentration of about 400USP Nystatin Units per mL.Dilute this stock solution quantitatively with Buffer No.6to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1407
Pharmacopeial Forum:Volume No.28(1)Page 134
Phone Number:1-301-816-8335