Nystatin Oral Suspension
» Nystatin Oral Suspension contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of USP Nystatin Units. It contains suitable dispersants, flavors, preservatives, and suspending agents.
Packaging and storage— Preserve in tight, light-resistant containers.
Change to read:
Uniformity of dosage units 905
Procedure for content uniformity— [note—Use low-actinic glassware. The correction factor, F, calculated as directed in section (4) of Content Uniformity under Uniformity of Dosage Units 905, is invalid if the value obtained by the formula in the second sentence is greater than 25; follow sections (5) and (6), except to substitute 0.750 for 0.900.] Transfer the well-shaken contents of 1 container of Oral Suspension to a 100-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix. Dilute an accurately measured volume of this solution quantitatively, and stepwise if necessary, with methanol to obtain a test solution containing about 25 USP Nystatin Units per mL. Similarly, prepare a Standard solution of USP Nystatin RS in methanol having a known concentration of about 25 USP Nystatin Units per mL. Concomitantly determine the absorbances of the test solution and the Standard solution at the wavelength of maximum absorbance at about 304 nm with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in USP Nystatin Units, in the container taken by the formula:
(CL/D)(AU / AS)
in which C is the concentration, in USP Nystatin Units per mL, of the Standard solution; L is the labeled quantity, in USP Nystatin Units, in the container; D is the concentration, in USP Nystatin Units, in the test solution, on the basis of the labeled quantity in the container and the extent of dilution; and AU and AS are the absorbances of the test solution and the Standard solution, respectively.
Deliverable volume 698: meets the requirements.
pH 791: between 4.5 and 6.0; or if it contains glycerin, between 5.3 and 7.5.
Assay— Proceed as directed for Nystatin under Antibiotics—Microbial Assays 81, blending a suitable accurately measured volume of Oral Suspension, freshly mixed and free from air bubbles, 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.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3123
Pharmacopeial Forum: Volume No. 34(1) Page 103
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.