Packaging and storage— Preserve in tight,light-resistant containers.

Labeling— Label the Tablets to indicate that they are intended for oral use only (as distinguished from Vaginal Tablets).

USP Reference standards á11ñ— USP Nystatin RS.

Disintegration á701ñ: if plain-coated,120minutes.

Loss on drying á731ñ— Dry about 100mg,accurately weighed,of powdered Tablets in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:if plain-coated,it loses not more than 5.0%of its weight;if film-coated,it loses not more than 8.0%of its weight.

Assay— Proceed as directed for Nystatin under Antibiotics—Microbial Assays á81ñ,blending not less than 5Tablets for 3to 5minutes in a high-speed blender with a sufficient accurately measured volume of dimethylformamide to obtain a solution of convenient concentration.Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing 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.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1408

Phone Number:1-301-816-8335