SPL Set ID: 9f1c8971-c6dc-4708-848b-5cee50b6c32a

Isotretinoin Capsules, USP Isotretinoin capsules, USP contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin, USP (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems: 10 mg – D&C yellow #10, FD&C yellow #6, FD&C red #40, FD&C blue #1 and titanium dioxide 20 mg – iron oxide (red), FD&C red #40, FD&C blue #1 and titanium dioxide 25 mg – FD&C Yellow #6, FD&C blue #1 and titanium dioxide 30 mg – D&C yellow #10, FD&C red #40, FD&C blue #1 and titanium dioxide 35 mg – FD&C Yellow #6, FD&C red #40, FD&C Blue #1 and titanium dioxide 40 mg – iron oxide (black, red and yellow), FD&C red #40, FD&C Blue #1 and titanium dioxide The black imprinting ink of 10 mg and 20 mg capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution (strong ammonia solution), iron oxide (black), potassium hydroxide and purified water. The white imprinting ink of 25 mg, 30 mg, 35 mg and 40 mg capsules contains the following ingredients: shellac, titanium dioxide, isopropyl alcohol, ammonia solution (ammonium hydroxide), propylene glycol, butyl alcohol (n-Butyl alcohol) and simethicone. Isotretinoin, USP Chemically, isotretinoin, USP 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: FDA approved dissolution test specifications differ from USP. Structural Formula