Nystatin Oral Suspension
»Nystatin Oral Suspension contains not less than 90.0percent and not more than 130.0percent 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.
Uniformity of dosage units á905ñ
FORSUSPENSION 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 á905ñ,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 0.750for 0.900.]Transfer the well-shaken contents of 1container of Oral Suspension to a 100-mLvolumetric 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 25USP Nystatin Units per mL.Similarly,prepare a Standard solution of USP Nystatin RSin methanol having a known concentration of about 25USP Nystatin Units per mL.Concomitantly determine the absorbances of the test solution and the Standard solution at the wavelength of maximum absorbance at about 304nm,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 Cis the concentration,in USP Nystatin Units per mL,of the Standard solution,Lis the labeled quantity,in USP Nystatin Units,in the container,Dis 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 AUand ASare the absorbances of the test solution and the Standard solution,respectively.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 4.5and 6.0;or if it contains glycerin,between 5.3and 7.5.
Assay— Proceed as directed for Nystatin under Antibiotics—Microbial Assays á81ñ,blending a suitable accurately measured volume of Oral Suspension,freshly mixed and free from air bubbles,for 3to 5minutes 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 400USP Nystatin Units per mL.Dilute this stock solution quantitatively with Buffer No.6to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1408
Pharmacopeial Forum:Volume No.28(1)Page 136
Phone Number:1-301-816-8335