» Nystatin Tablets contain 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 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 11
Disintegration 701: if plain-coated, 120 minutes.
Loss on drying 731 Dry about 100 mg, accurately weighed, of powdered Tablets in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: 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 AntibioticsMicrobial Assays 81, blending not less than 5 Tablets for 3 to 5 minutes 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 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 4093Pharmacopeial Forum: Volume No. 28(1) Page 137