» 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).
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.Chromatographic Column
USP32NF27 Page 3123Pharmacopeial Forum: Volume No. 28(1) Page 137
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.