Nystatin Tablets
» Nystatin Tablets contain not less than 90.0 percent and not more than 130.0 percent of the labeled amount of USP Nystatin Units.
Packaging and storage—
Preserve in tight, light-resistant containers.
Labeling—
Label the Tablets to indicate that they are intended for oral use only (as distinguished from Vaginal Tablets).
USP Reference standards 
11
—
11—
USP Nystatin RS 
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Disintegration 701:
if plain-coated, 120 minutes.
701:
if plain-coated, 120 minutes.
Loss on drying 731—
Dry about 100 mg, accurately weighed, of powdered Tablets in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60
for 3 hours: if plain-coated, it loses not more than 5.0% of its weight; if film-coated, it loses not more than 8.0% of its weight.
731—
Dry about 100 mg, accurately weighed, of powdered Tablets in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: if plain-coated, it loses not more than 5.0% of its weight; if film-coated, it loses not more than 8.0% of its weight.
Assay—
Proceed as directed for Nystatin under Antibiotics—Microbial Assays 81, blending not less than 5 Tablets for 3 to 5 minutes in a high-speed blender with a sufficient accurately measured volume of dimethylformamide to obtain a solution of convenient concentration. Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
81, blending not less than 5 Tablets for 3 to 5 minutes in a high-speed blender with a sufficient accurately measured volume of dimethylformamide to obtain a solution of convenient concentration. Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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 |
|
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
USP35–NF30 Page 4093
Pharmacopeial Forum: Volume No. 28(1) Page 137