Nystatin for Oral Suspension

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 for Oral Suspension is a dry mixture of Nystatin with one or more suitable colors, diluents, suspending agents, flavors, and preservatives. It contains the equivalent of NLT 90.0% and NMT 140.0% 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. Constitute Nystatin for Oral Suspension as directed in the labeling. Blend a suitable aliquot of the suspension, freshly mixed and free from air bubbles, 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 the resulting 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%–140.0% of the labeled amount of USP Nystatin Units

3 PERFORMANCE TESTS

3.1 Uniformity of Dosage Units 〈905〉

For powder packaged in single-unit containers

Acceptance criteria: Meets the requirements

3.2 Deliverable Volume 〈698〉

For powder packaged in multiple-unit containers

Acceptance criteria: Meets the requirements

4 SPECIFIC TESTS

pH 〈791〉

Sample suspension: Constitute as directed in the labeling.

Acceptance criteria: 4.9–5.5

Water Determination, Method I 〈921〉: Acceptance criteria: NMT 7.0%

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Nystatin RS