Nystatin Tablets
» 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
USP Nystatin RS Click to View Structure
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 Antibiotics—Microbial 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.
Topic/Question Contact Expert Committee
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701 Margareth R.C. Marques, Ph.D.
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