Nystatin Tablets
If you find any inaccurate information, please let us know by providing your feedback here
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 Tablets contain NLT 90.0% and NMT 130.0% of the labeled amount of USP Nystatin Units.
2 ASSAY
2.1 Procedure
(See Antibiotics—Microbial Assays 〈81〉.)
Sample solution: 400 USP Nystatin Units/mL prepared as follows. Blend NLT 5 Tablets for 3–5 min in a high-speed blender with a sufficient volume of dimethylformamide to obtain a solution of suitable concentration. Dilute a portion of this solution with 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
Disintegration 〈701〉
Time: If plain-coated, 120 min
Acceptance criteria: Meet the requirements
4 SPECIFIC TESTS
Loss on Drying 〈731〉
Sample: 100 mg of powdered Tablets
Analysis: Dry the Sample in a capillary-stoppered bottle under vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h.
Acceptance criteria: If plain-coated, NMT 5.0%; if film-coated, NMT 8.0%
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant containers.
Labeling: Label the Tablets to indicate that they are intended for oral use only (as distinguished from Vaginal Tablets).
USP Reference Standards 〈11〉
USP Nystatin RS
