SPL Set ID: 86620f6c-fd02-40df-98d5-3048dcd92c37
1 drug(s) with this SPL Set ID
Estradiol vaginal inserts, USP 10 mcg are white to off-white, round, film-coated, bi-convex vaginal inserts, debossed with ‘G’ on one side and ‘94’ on the other side and containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Each estradiol vaginal insert, USP 10 mcg contains the following excipients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each estradiol vaginal insert, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP, 10 mcg are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate, USP is a white, almost white, crystalline powder, chemically described as (8R,9S,13S,14S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.39. The structural formula is: USP Dissolution Test Pending. structure