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.
USP Reference standards 11
USP Nystatin RS Click to View Structure
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.
Assay— Proceed with Ointment as directed in the Assay under Nystatin Cream.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 4092
Pharmacopeial Forum: Volume No. 28(1) Page 135