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 11
USP Nystatin RS Click to View Structure
Uniformity of dosage units 905
for powder packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for powder packaged in multiple-unit containers: meets the requirements.
pH 791: between 4.9 and 5.5, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 7.0%.
Assay— Constitute Nystatin for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Nystatin Oral Suspension.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 4093
Pharmacopeial Forum: Volume No. 30(1) Page 143