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

Nystatin Vaginal Inserts

(Monograph under this new title—to become official October 1,2005)

(Current monograph title is Nystatin Vaginal Tablets)

»Nystatin Vaginal Inserts are composed of Nystatin with suitable binders,diluents,and lubricants.Vaginal Inserts 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 Inserts 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 Inserts as directed in the Assayunder Nystatin Tablets.

(Official October 1,2005)

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