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.

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.

Residual solvents 467: meet the requirements.

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.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1569

Phone Number : 1-301-816-8223