Nystatin for Oral Suspension, chemical structure, molecular formula, Reference Standards

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

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Nystatin RS.

Add the following:

Uniformity of dosage units á905ñ—

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

USP28

Add the following:

Deliverable volume á698ñ—

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

USP28

pHá791ñ: between 4.9and 5.5,in the suspension constituted as directed in the labeling.

Water,Method Iá921ñ: not more than 7.0%.

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

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1408

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

Phone Number:1-301-816-8335