Nystatin Cream
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Nystatin Cream contains NLT 90.0% and NMT 130.0% of the labeled amount of USP Nystatin Units.
2 ASSAY
PROCEDURE
(See Antibiotics-Microbial Assays (81).)
Sample solution: 400 USP Nystatin Units/mL prepared as follows. Blend a suitable portion of Cream in a high-speed blender for 3-5 min with a suitable volume of dimethylformamide.
Analysis: Proceed as directed in the chapter. Dilute an aliquot of the Sample solution with Buffer B.6 to obtain a Test Dilution having a nystatin concentration assumed to be equal to the median level of the standard.
Acceptance criteria: 90.0%-130.0% of the labeled amount of USP Nystatin Units
3 PERFORMANCE TESTS
MINIMUM FILL (755); Meets the requirements
4 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in collapsible tubes, or in other tight containers, and avoid exposure to excessive heat.
USP REFERENCE STANDARDS (11)
USP Nystatin RS
