USP Monographs: Nystatin for Oral Suspension


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Nystatin for Oral Suspension

» 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 not less than 90.0 percent and not more than 140.0 percent of the labeled amount of USP Nystatin Units.

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Nystatin RS.

Uniformity of dosage units

—

FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume

—

FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

pH

: between 4.9 and 5.5, in the suspension constituted as directed in the labeling.

Water, Method I

: not more than 7.0%.

Residual solvents

: meets the requirements.

(Official January 1, 2007)

Assay— Constitute Nystatin for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Nystatin Oral Suspension.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1569

Pharmacopeial Forum : Volume No. 30(1) Page 143

Phone Number : 1-301-816-8223