U.S. PHARMACOPEIA

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Nystatin Lozenges
» Nystatin Lozenges contain not less than 90.0 percent and not more than 125.0 percent of the labeled amount of USP Nystatin Units.
Packaging and storage— Preserve in tight, light-resistant containers.
Disintegration 701: 90 minutes, determined as set forth under Uncoated Tablets.
pH 791: between 5.0 and 7.5, in a solution prepared by dissolving 1 Lozenge in 100 mL of water at 37 and allowing the solution to cool to room temperature.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed as directed for Nystatin under Antibiotics—Microbial Assays 81, blending not less than 5 Lozenges for 18 to 20 minutes in a high-speed blender jar containing 100.0 mL of water. Add 400.0 mL of dimethylformamide, and blend for an additional 10 minutes. Dilute an accurately measured volume of this solution quantitatively with a mixture of dimethylformamide and water (4:1) to obtain a stock solution containing about 400 USP Nystatin Units per mL. Dilute an accurately measured volume of this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a nystatin concentration assumed to be equal to the median dose level of the Standard. [NOTE—The Test Dilution of the specimen and the test dilutions of the Standard contain the same amount of dimethylformamide (about 4%).]
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1568
Pharmacopeial Forum : Volume No. 28(1) Page 135
Phone Number : 1-301-816-8223