Nystatin Vaginal Inserts

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Nystatin Vaginal Inserts are composed of Nystatin with suitable binders, diluents, and lubricants. Vaginal Inserts contain NLT 90.0% and NMT 140.0% of the labeled amount of USP Nystatin Units.

2 ASSAY

2.1 Nystatin

(See Antibiotics—Microbial Assays 〈81〉.)

Sample stock solution: 400 USP Nystatin Units/mL in dimethylformamide prepared as follows. Blend NLT 5 Vaginal Inserts 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.

Test dilution: Dilute a volume of the Sample stock solution with Buffer B.6 to obtain a nystatin concentration assumed to be equal to the median dose level of the standard.

Acceptance criteria: 90.0%–140.0% of the labeled amount of USP Nystatin Units

3 PERFORMANCE TESTS

3.1 Disintegration 〈701〉

Time: 60 min

Analysis: Use the Procedure for Uncoated Tablets in the chapter.

Acceptance criteria: Meets the requirements

4 SPECIFIC TESTS

Loss on Drying 〈731〉

Dry 100 mg of powdered Vaginal Inserts in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h: it loses NMT 5.0% of its weight.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers and, where so specified in the labeling, in a refrigerator.

USP Reference Standards 〈11〉

USP Nystatin RS