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.
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%.
Auxiliary Information Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28NF23Page 1408Pharmacopeial Forum:Volume No.30(1)Page 143