Packaging and storage
Preserve in tight, light-resistant containers.
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.
Assay
Proceed as directed for Nystatin under
AntibioticsMicrobial 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.
[NOTEThe
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
USP29NF24 Page 1568
Pharmacopeial Forum : Volume No. 28(1) Page 135
Phone Number : 1-301-816-8223