SPL Set ID: 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6

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 – gelatin, iron oxide yellow and titanium dioxide; 20 mg – gelatin, iron oxide red and titanium dioxide; 25 mg – D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and titanium dioxide; 30 mg – gelatin, iron oxide (black, red and yellow) and titanium dioxide; 35 mg – FD&C Blue #1, FD&C Red #3, FD&C Yellow #6, gelatin and titanium dioxide; 40 mg – gelatin, iron oxide (black, red and yellow) and titanium dioxide. The black imprinting ink of 10 mg and 20 mg capsules contain the following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. The white imprinting ink of 25 mg, 30 mg, 35 mg and 40 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide. In addition 10 mg and 20 mg capsules contain band sealing composition: gelatin and polysorbate 80. Isotretinoin Chemically, isotretinoin USP is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in methylene chloride, slightly soluble in alcohol. The structural formula is: FDA approved dissolution test specifications differ from USP. Structure