Nystatin Vaginal Inserts
» Nystatin Vaginal Inserts are composed of Nystatin with suitable binders, diluents, and lubricants. Vaginal Inserts contain not less than 90.0 percent and not more than 140.0 percent 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.
Disintegration 701: 60 minutes.
Loss on drying 731 Dry about 100 mg, accurately weighed, of powdered Vaginal Inserts in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 5.0% of its weight.
Assay— Proceed with Vaginal Inserts as directed in the Assay under Nystatin Tablets.
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
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3124
Pharmacopeial Forum: Volume No. 29(3) Page 642