Nystatin Tablets
»Nystatin Tablets contain not less than 90.0percent and not more than 130.0percent of the labeled amount of USP Nystatin Units.
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).
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.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1408
Pharmacopeial Forum:Volume No.28(1)Page 137
Phone Number:1-301-816-8335