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