USP Monographs: Nystatin Vaginal Inserts

Nystatin Vaginal Inserts

Former title:

Nystatin Vaginal Tablets

» 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.

USP Reference standards

— USP Nystatin RS.

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.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

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

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1569

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

Phone Number : 1-301-816-8223


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