SPL Set ID: bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2

Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is: FDA approved dissolution test method differs from the USP dissolution test methods.