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
—
11—
USP Nystatin RS 
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Uniformity of dosage units 905—
905—
for powder packaged in single-unit containers:
meets the requirements.
Deliverable volume 698—
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.
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%.
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 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4093
Pharmacopeial Forum: Volume No. 30(1) Page 143