Nystatin Vaginal Tablets, chemical structure, molecular formula, Reference Standards

Nystatin Vaginal Tablets

(Current title—not to change until October 1,2005)

Monograph title change—to become official October 1,2005

See Nystatin Vaginal Inserts

»Nystatin Vaginal Tablets are composed of Nystatin with suitable binders,diluents,and lubricants.Tablets contain not less than 90.0percent and not more than 140.0percent of the labeled amount of USP Nystatin Units.

Packaging and storage— Preserve in tight,light-resistant containers and,where so specified in the labeling,in a refrigerator.

USP Reference standards á11ñ— USP Nystatin RS.

Disintegration á701ñ: 60minutes.

Loss on drying á731ñ— Dry about 100mg,accurately weighed,of powdered Vaginal Tablets in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60

for 3hours:it loses not more than 5.0%of its weight.

Assay— Proceed with Vaginal Tablets as directed in the Assayunder Nystatin Tablets.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1409

Pharmacopeial Forum:Volume No.29(3)Page 642

Phone Number:1-301-816-8335