FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS : meets the requirements, except that under section (B)(3) of the Criteria, the words “average of the limits” are changed to “upper assay limit.”

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: 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.

(Official January 1, 2007)