U.S. PHARMACOPEIA

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Nystatin Ointment
» Nystatin Ointment contains 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 well-closed containers, preferably at controlled room temperature.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Ointment as directed in the Assay under Nystatin Cream.
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