SPL Set ID: 08529687-26b2-41e5-b6fb-35b4c0d891fe

Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is: Meets USP Dissolution Test 6. Chemical Structure